Page last updated: 2024-11-07

vitamin b 6

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Description

Vitamin B 6: VITAMIN B 6 refers to several PICOLINES (especially PYRIDOXINE; PYRIDOXAL; & PYRIDOXAMINE) that are efficiently converted by the body to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, and aminolevulinic acid. During transamination of amino acids, pyridoxal phosphate is transiently converted into PYRIDOXAMINE phosphate. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990). Most of vitamin B6 is eventually degraded to PYRIDOXIC ACID and excreted in the urine. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID104817
MeSH IDM0018248

Synonyms (8)

Synonym
8059-24-3
vitamin b 6
(5-hydroxy-4,6-dimethylpyridin-3-yl)methyl phosphate
A19429
einecs 232-503-8
FT-0636608
AKOS015891944
vitamin b6,(s)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Treatment of the toxic hepatitis with heptral increased the level of cytochrome P450, cytochrome b5, glutation activity of glutationetranspherase glutathione and reduced content of homocysteine."( [Efficacy and safety of heptral, vitamin B6 and folic acid during toxic hepatitis induced by CCL4].
Antelava, NA; Gogoluari, LI; Gogoluari, MI; Okudzhava, MV; Pirtskhalaĭshvili, NN, 2007
)
0.34
" However, haematological toxic effects of linezolid frequently limit its prolonged use, especially in patients with poor marrow reserves such as those with cancer receiving chemotherapy."( The role of vitamin B6 in the prevention of haematological toxic effects of linezolid in patients with cancer.
Adachi, J; Chemaly, RF; Hachem, R; Raad, I; Rolston, K; Ying, J; Youssef, S, 2008
)
0.35
" We found no significant differences in the rate of haematological toxic effects between the two patient groups."( The role of vitamin B6 in the prevention of haematological toxic effects of linezolid in patients with cancer.
Adachi, J; Chemaly, RF; Hachem, R; Raad, I; Rolston, K; Ying, J; Youssef, S, 2008
)
0.35
" Safety was assessed by evaluation of vital functions, laboratory tests, ECG, registration of adverse events (AE)."( [Evaluation of efficiency and safety of adding neuromultivit to basic therapy of vertebrogenic radiculopathy].
Granatov, EV; Khabirov, FA; Khaibullin, TI,
)
0.13
" In light of this, the number of reported cases of adverse health effects due to the use of vitamin B-6 have increased."( Vitamin B-6-Induced Neuropathy: Exploring the Mechanisms of Pyridoxine Toxicity.
Hadtstein, F; Vrolijk, M, 2021
)
0.62
"It is challenging for physicians to prescribe a safe dose of B6 supplements because of the narrow therapeutic index."( Preventing Vitamin B6-Related Neurotoxicity.
Reddy, P,
)
0.13
"Levetiracetam (LVT), while an effective treatment for multiple seizure types, is associated with a high incidence of neuropsychiatric adverse events (NPAEs)."( Current evidence for adjunct pyridoxine (vitamin B6) for the treatment of behavioral adverse effects associated with levetiracetam: A systematic review.
Besag, FMC; Sen, A; Vasey, MJ, 2023
)
0.91
" One RCT reported significant improvements from baseline in behavioral adverse events (BAEs) in both the intervention (PN) group and the low-dose control group (both p < 0."( Current evidence for adjunct pyridoxine (vitamin B6) for the treatment of behavioral adverse effects associated with levetiracetam: A systematic review.
Besag, FMC; Sen, A; Vasey, MJ, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
"The objectives of these analyses were to (1) develop a semimechanistic-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model to describe neutropenic response to pemetrexed and to (2) identify influential covariates with respect to pharmacodynamic response."( A semimechanistic-physiologic population pharmacokinetic/pharmacodynamic model for neutropenia following pemetrexed therapy.
Ghosh, A; Johnson, RD; Karlsson, MO; Latz, JE; Rusthoven, JJ, 2006
)
0.33
" The results showed no differences of pharmacokinetic behaviors between cyclophosphamide administration with and without vitamin B6."( Comparative pharmacokinetics of cyclophosphamide administration alone and combination with vitamin B6 in rats.
Bi, K; Chen, X; Gu, L; Hou, P; Jiang, Y; Ju, P; Ma, B; Zeng, Y; Zhang, L; Zhang, Y, 2015
)
0.42

Compound-Compound Interactions

ExcerptReferenceRelevance
" The validated method was successfully applied to evaluate the drug-drug interaction of cyclophosphamide and vitamin B6 in rat plasma."( Comparative pharmacokinetics of cyclophosphamide administration alone and combination with vitamin B6 in rats.
Bi, K; Chen, X; Gu, L; Hou, P; Jiang, Y; Ju, P; Ma, B; Zeng, Y; Zhang, L; Zhang, Y, 2015
)
0.42
"To evaluate the efficacy of mannatide combined with sodium cantharidate vitamin B6 in the treatment of malignant pleural effusions."( Efficacy of mannatide combined with sodium cantharidate vitamin B6 in the treatment of malignant pleural effusions.
Song, J; Wang, LZ; Zhang, HJ, 2015
)
0.42
" Injection into the thorax using mannatide combined with sodium cantharidate vitamin B6 was performed for 37 patients in the experimental group and mannatide combined with cisplatin for 32 patients in the control group."( Efficacy of mannatide combined with sodium cantharidate vitamin B6 in the treatment of malignant pleural effusions.
Song, J; Wang, LZ; Zhang, HJ, 2015
)
0.42
"Regimen of mannatide combined with sodium cantharidate vitamin B6 had better improvement in quality-of-life and symptom relief, with a lower side-effect incidence in treatment of malignant pleural effusions."( Efficacy of mannatide combined with sodium cantharidate vitamin B6 in the treatment of malignant pleural effusions.
Song, J; Wang, LZ; Zhang, HJ, 2015
)
0.42
"To evaluate the therapeutic effect of progesterone in combination with vitamin B6 in the treatment of antipsychotic-induced amenorrhea."( Clinical Study of Progesterone Combined with Vitamin B6 in the Treatment of Amenorrhea Endocrine Disorders Caused by Antipsychotics.
Hu, S; Ran, L; Wang, M; Zhai, W; Zhao, Y, 2022
)
0.72
" Among them, the progesterone group was treated only with progesterone, while the vitamin B6 group was given progesterone in combination with vitamin B6."( Clinical Study of Progesterone Combined with Vitamin B6 in the Treatment of Amenorrhea Endocrine Disorders Caused by Antipsychotics.
Hu, S; Ran, L; Wang, M; Zhai, W; Zhao, Y, 2022
)
0.72
"The effectiveness of progesterone combined with vitamin B6 in treating amenorrhea caused by antipsychotics is significantly better than simple progesterone, which can effectively improve the endocrine condition of patients and provide a reference for the clinical treatment of amenorrhea caused by antipsychotics."( Clinical Study of Progesterone Combined with Vitamin B6 in the Treatment of Amenorrhea Endocrine Disorders Caused by Antipsychotics.
Hu, S; Ran, L; Wang, M; Zhai, W; Zhao, Y, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
" Mechanisms responsible for endothelial dysfunction in hyperhomocyst(e)inemia may involve impaired bioavailability of NO, possibly secondary to accumulation of the endogenous NO synthase inhibitor asymmetric dimethylarginine (ADMA) and increased oxidative stress."( ADMA and oxidative stress are responsible for endothelial dysfunction in hyperhomocyst(e)inemia: effects of L-arginine and B vitamins.
Arakawa, N; Bode-Böger, SM; Böger, RH; Frölich, JC; Hornig, B; Schwedhelm, E; Sydow, K; Tsikas, D, 2003
)
0.32
" The results of the validation showed that for males, a model using a fixed bioavailability factor at the food group level was valid, while for females a model using either a fixed value or a distribution for the bioavailability factor was valid."( Validation and sensitivity analysis of probabilistic models of dietary exposure to micronutrients: an example based on vitamin B6.
Brussaard, JH; Hulshof, KF; Kruizinga, AG; Rubingh, CM, 2003
)
0.32
" Folate and vitamin B12 levels rose significantly, suggesting that the supplement was well absorbed and that participants adhered to the protocol."( Effects of short-term supplementation with ascorbate, folate, and vitamins B6 and B12 on inflammatory factors and estrogen levels in obese postmenopausal women.
Palmas, W, 2006
)
0.33
" Due to the health implications of a marginal pyridoxine status, vegans should be encouraged to include foods with a high bioavailability of pyridoxine, such as beans, lentils and bananas, in the daily diet."( Dietary intake of vitamin B6 and concentration of vitamin B6 in blood samples of German vegans.
Dörr, B; Hahn, A; Koschizke, JW; Leitzmann, C; Waldmann, A, 2006
)
0.33
" Natural food folates have a limited ability to enhance folate status as a result of their poor stability under typical cooking conditions and incomplete bioavailability when compared with the synthetic vitamin, folic acid (as found in supplements and fortified foods)."( Intake and status of folate and related B-vitamins: considerations and challenges in achieving optimal status.
McNulty, H; Scott, JM, 2008
)
0.35
"A crossover single-dose bioavailability study (n = 3) using gamma-tocopherol as exposure marker and a crossover unblinded dietary intervention study (5 weeks) in subjects at risk (n = 25)."( Consumption of restructured meat products with added walnuts has a cholesterol-lowering effect in subjects at high cardiovascular risk: a randomised, crossover, placebo-controlled study.
Blanco-Navarro, I; Blázquez-García, S; Granado-Lorencio, F; Herrero-Barbudo, C; Olmedilla-Alonso, B; Pérez-Sacristán, B, 2008
)
0.35
" Due to the low bioavailability of the hydrosolubile forms of thiamine, its liposolubile preparations (benfotiamine) are preferentially used."( [The effect of benfothiamine in the therapy of diabetic polyneuropathy].
Apostolski, S; Basta, I; Kacar, A; Lavrnić, D; Nikolić, A,
)
0.13
"Oat-bran helps to improve constipation management and B12 bioavailability in elderly, with multiple chronic diseases who live in nursing homes."( The status of vitamins B6, B12, folate, and of homocysteine in geriatric home residents receiving laxatives or dietary fiber.
Dietrich, A; Elmadfa, I; Gisinger, C; Sturtzel, B; Wagner, KH, 2010
)
0.36
"Homocysteine is a cardiovascular risk factor, its metabolism is influenced by certain B vitamins and it is associated with endothelial dysfunction probably due to impaired bioavailability of NO caused by homocysteine-induced accumulation of asymmetric dimethylarginine (ADMA), an endogenous inhibitor of NO synthase."( Homocysteine and asymmetric dimethylarginine in relation to B vitamins in elderly people.
Elmadfa, I; Fabian, E; Kickinger, A; Wagner, KH, 2011
)
0.37
"The significant correlation between homocysteine and ADMA observed in this study may be an important mechanism decreasing NO bioavailability and so causing endothelial dysfunction."( Homocysteine and asymmetric dimethylarginine in relation to B vitamins in elderly people.
Elmadfa, I; Fabian, E; Kickinger, A; Wagner, KH, 2011
)
0.37
"Bioconjugates of a polyamidoamine (PAMAM) G3 dendrimer and an aldehyde were synthesized as carriers for vitamins A and B₆, and the bioavailability of these vitamins for skin nutrition was investigated."( Bioconjugates of PAMAM dendrimers with trans-retinal, pyridoxal, and pyridoxal phosphate.
Filipowicz, A; Wołowiec, S, 2012
)
0.38
" Carbohydrate-rich diet triggers insulin response to enhance the bioavailability of tryptophan in the CNS which is responsible for increased craving of carbohydrate diets."( Effect of diet on serotonergic neurotransmission in depression.
Bose, S; Krishnamohan, R; Mattison, C; Nel, W; Ngu, N; Patel, A; Rais, A; Sandhu, R; Sandhu, S; Shabbir, F; Sharma, S; Sweeney, E, 2013
)
0.39
" Vitamin B6 (B6) is a cofactor, and genetic polymorphisms of related key enzymes, such as serine hydroxymethyltransferase (SHMT), methionine synthase reductase (MTRR), and methionine synthase (MS), in FMOCM may govern the bioavailability of metabolites and play important roles in the maintenance of genomic stability and cell viability (GSACV)."( The Role of Genetic Polymorphisms as Related to One-Carbon Metabolism, Vitamin B6, and Gene-Nutrient Interactions in Maintaining Genomic Stability and Cell Viability in Chinese Breast Cancer Patients.
Cao, N; Fenech, M; Liang, Z; Ni, J; Wang, X; Wu, X; Xu, W; Zhou, T; Zou, T, 2016
)
0.43
" However, the bioavailability of the vitamin in the edible portions of the commonly consumed plants is insufficient to meet the daily recommended doses."( Overexpression of PDX-II gene in potato (Solanum tuberosum L.) leads to the enhanced accumulation of vitamin B6 in tuber tissues and tolerance to abiotic stresses.
Bagri, DS; Kumar, A; Upadhyaya, CP; Upadhyaya, DC, 2018
)
0.48
"To investigate the ingredients' bioavailability of the complex vitamin-mineral-trace element composition LaVita® we recruited healthy volunteers for six months and observed the changes of pregnancy relevant parameters by means of laboratory measures."( Potential of the multivitamin-mineral-trace element composition LaVita® before, during and after pregnancy.
Doerfler, D; Endler, TA; Mosgoeller, W; Muss, C, 2019
)
0.51
" Prolonged circulation half-life and tumor site bioavailability were achieved for both the drugs with the developed approach."( Targeted co-delivery of the aldose reductase inhibitor epalrestat and chemotherapeutic doxorubicin via a redox-sensitive prodrug approach promotes synergistic tumor suppression.
Banala, VT; Dwivedi, M; Gautam, S; Marwaha, D; Mishra, PR; Sharma, M; Sharma, S; Shukla, RP; Urandur, S, 2019
)
0.51
"Vitamin B6 from plant foods may have lower bioavailability than vitamin B6 from animal foods, but studies on objectively measured vitamin B6 status among vegetarians compared to non-vegetarians are lacking."( Vitamin B6 Status among Vegetarians: Findings from a Population-Based Survey.
Bärnighausen, T; Cassidy, A; Karavasiloglou, N; Kühn, T; Rohrmann, S; Schorgg, P, 2021
)
0.62
" Food preparation and processing operations affect contents and bioavailability of micronutrients in traditional dishes."( Nutrient retention in popular dishes based on Google Trends data in Hatay cuisine.
Güçlü, D; Öney, B; Yılmaz, SE, 2023
)
0.91

Dosage Studied

ExcerptRelevanceReference
" Mild side effects, such as gastrointestinal symptoms and liver dysfunction, are observed in 40-70%, but these resolve after discontinuation or a reduction of the dosage of vitamin B(6)."( High-dose vitamin B(6) treatment in West syndrome.
Toribe, Y, 2001
)
0.31
" The results of preformulation studies enabled detection of drug-excipients interactions and selection of compatible excipient system to the given drug composition to formulate dosage form of required stability, processability and effectiveness."( [Formulation of tablets decreasing plasma homocysteine levels].
Budavári, Z, 2001
)
0.31
" Sample preparation was relatively simple whereas excipients present in the dosage forms did not interfere with the peaks of interest."( An optimized method for the simultaneous determination of vitamins B1, B6, B12 in multivitamin tablets by high performance liquid chromatography.
Kagkadis, KA; Koundourellis, JE; Markopoulou, CK, 2002
)
0.31
" In addition, a significant dose-response relation between plasma folate concentrations and risk for schizophrenia suggested a protective effect by high plasma folate concentrations."( Homocysteine metabolism and B-vitamins in schizophrenic patients: low plasma folate as a possible independent risk factor for schizophrenia.
Blom, H; Ellenbroek, B; Eskes, T; Muntjewerff, JW; Steegers, E; van der Put, N; Zitman, F, 2003
)
0.32
" Starting at a plasma homocysteine concentration of approximately 10 micromol/l, the risk increase follows a linear dose-response relationship with no specific threshold level."( DACH-LIGA homocystein (german, austrian and swiss homocysteine society): consensus paper on the rational clinical use of homocysteine, folic acid and B-vitamins in cardiovascular and thrombotic diseases: guidelines and recommendations.
Dierkes, J; Fowler, B; Geisel, J; Herrmann, W; Pietrzik, K; Stanger, O; Weger, M, 2003
)
0.32
" There was no difference in Hcy reduction following the administration of either high or low dosage of vitamins B6 and B12 utilized in the present study."( Comparative study of response to treatment with supraphysiologic doses of B-vitamins in hyperhomocysteinemic hemodialysis patients.
Abassi, Z; Brenner, B; Green, J; Khankin, E; Lanir, N; Nakhoul, F; Plawner, M; Ramadan, R, 2004
)
0.32
" The investigation of the dose-response effects of B vitamin supplementation on cognition and mood in middle-aged men and women using objective measures of cognition and accounting for the influence of confounding factors such age and education would be informative."( Associations between dietary intake of folate and vitamins B-12 and B-6 and self-reported cognitive function and psychological well-being in Australian men and women in midlife.
Bryan, J; Calvaresi, E, 2004
)
0.32
" Dose-response relationships, a criterion for causality, were examined linking exposures to likelihood of case status."( Case-control study of multiple chemical sensitivity, comparing haematology, biochemistry, vitamins and serum volatile organic compound measures.
Baines, CJ; Cole, DE; Jazmaji, V; Loescher, B; Marshall, L; McKeown-Eyssen, GE; Riley, N, 2004
)
0.32
" Notably, adjusted (for age and sex) dose-response curves for the postmethionine increase in homocysteine or fasting homocysteine versus betaine showed that the inverse associations were most pronounced at low serum folate, an observation that was confirmed by analyses of interaction."( Betaine and folate status as cooperative determinants of plasma homocysteine in humans.
Blom, HJ; den Heijer, M; Holm, PI; Keijzer, MB; Midttun, Ø; Ueland, PM; Vollset, SE, 2005
)
0.33
" Pyridoxine is preventative in low dosage and curative in high dosage."( [Isoniazid induced neuropathy: consider prevention].
De Broucker, T; Martinez-Almoyna, L; Steichen, O, 2006
)
0.33
" Dietary vitamins E and C were statistically significantly protective for both colon and rectal cancer at all levels of consumption, and for both vitamins there was a dose-response effect of increasing protection, particularly so for colon cancer."( Colorectal cancer protective effects and the dietary micronutrients folate, methionine, vitamins B6, B12, C, E, selenium, and lycopene.
Kune, G; Watson, L, 2006
)
0.33
" It included (1) the drugs used for the treatment, (2) their dosage, and (3) the dosage and the schedule of adrenocorticotropic hormone therapy."( Current treatment of West syndrome in Japan.
Ito, M; Okumura, A; Ozawa, H; Tsuji, T; Watanabe, K, 2007
)
0.34
" To our knowledge, this is the highest dosage of vitamin B6 administered to humans over prolonged periods of time ever reported in the medical literature."( Severe sensorimotor neuropathy after intake of highest dosages of vitamin B6.
Gdynia, HJ; Kassubek, J; Kühnlein, P; Ludolph, AC; Müller, T; Otto, M; Sperfeld, AD, 2008
)
0.35
" An increased risk of colon cancer was suggested for men in the middle quintile of serum folate, but without indication of a dose-response relationship."( One-carbon metabolism biomarkers and risk of colon and rectal cancers.
Albanes, D; Graubard, B; Lim, U; Selhub, J; Stolzenberg-Solomon, R; Taylor, PR; Virtamo, J; Weinstein, SJ, 2008
)
0.35
"The pregnant C57BL/6J mice were dosed with 24 microg TCDD/kg and/or 5, 10, 20, and 40 mg B(6)/kg body weight on gestation day (GD) 10."( Experimental study on protection of vitamin B6 on TCDD-induced palatal cleft formation in the mice.
He, W; Li, CH; Meng, T; Shi, B, 2009
)
0.35
"There was a strong dose-response relation of plasma PLP concentration with plasma CRP."( Association of vitamin B-6 status with inflammation, oxidative stress, and chronic inflammatory conditions: the Boston Puerto Rican Health Study.
Lai, CQ; Mattei, J; Ordovas, JM; Shen, J; Tucker, KL, 2010
)
0.36
" However, no dose-response relation was observed."( Folate and other one-carbon metabolism-related nutrients and risk of postmenopausal breast cancer in the Cancer Prevention Study II Nutrition Cohort.
Gapstur, SM; McCullough, ML; Stevens, VL; Sun, J, 2010
)
0.36
" The proposed models were applied successfully to simultaneous determination of B1 and B6 in presence of a low concentration of B12 in pharmaceutical dosage forms that contain simple excipients."( Development and validation of PCR, PLS, and TLC densitometric methods for the simultaneous determination of vitamins B(1), B(6) AND B(12) in pharmaceutical formulations.
Elzanfaly, ES; Nebsen, M; Ramadan, NK, 2010
)
0.36
"There were no significant dose-response relations between any plasma- or FFQ-measured dietary factors and relative telomere length in multivariate analyses."( One-carbon metabolism factors and leukocyte telomere length.
De Vivo, I; Giovannucci, E; Hankinson, SE; Liu, JJ; Prescott, J; Rosner, B, 2013
)
0.39
" Dose-response relationship was assessed by restricted cubic spline."( Association of vitamin B6, vitamin B12 and methionine with risk of breast cancer: a dose-response meta-analysis.
Kang, S; Wu, W; Zhang, D, 2013
)
0.39
" Linear dose-response relationship was found, and the risk of breast cancer decreased by 23% (P<0."( Association of vitamin B6, vitamin B12 and methionine with risk of breast cancer: a dose-response meta-analysis.
Kang, S; Wu, W; Zhang, D, 2013
)
0.39
" B6 was administered orally starting at 5 mg/kg body weight per day and given in increments of 5 mg/kg every 6 weeks, up to a final dosage of 20 mg/kg per day at week 24."( Vitamin B6 in primary hyperoxaluria I: first prospective trial after 40 years of practice.
Beck, BB; Franklin, J; Hero, B; Hoppe, B; Hoyer-Kuhn, H; Kohbrok, S; Volland, R, 2014
)
0.4
" Second, in vivo effect of different dosage patterns and concentrations in the development of hepatic metastasis was analyzed by intra-splenic inoculation of C26 colon carcinoma cells in Balb/c mice."( Ocoxin® oral solution slows down tumor growth in an experimental model of colorectal cancer metastasis to the liver in Balb/c mice.
Arteta, B; Benedicto, A; Hernandez-Unzueta, I; Márquez, J; Mena, J; Olaso, E; Sanz, E, 2016
)
0.43
" Normal dosage isocarboxazide may be prescribed for all patients because isocarboxazide is not metabolized through the CYP2D6 enzyme complex like most other antidepressants."( [The use of the monoamine oxidase inhibitor isocarboxazide in treatment-resistant depression].
Brøsen, K; Krogh-Nielsen, L; Larsen, JK, 2015
)
0.42
" Multivitamin supplements were taken at a dosage of one pill every day for 12 weeks through the oral route."( Effects of Multivitamin Supplements on Cognitive Function, Serum Homocysteine Level, and Depression of Korean Older Adults With Mild Cognitive Impairment in Care Facilities.
Kim, SY; Lee, HK; Sok, SR, 2016
)
0.43
"1 mg of folic acid in combination with vitamin B6 and B12 is less effective in reducing migraine associated symptoms compared to the previously tested dosage of 2 mg folic acid in combination with 25 mg of vitamin B6 and 400 μg of vitamin B12."( The effect of 1 mg folic acid supplementation on clinical outcomes in female migraine with aura patients.
Avgan, N; Ghassabian, S; Griffiths, L; Lea, R; Menon, S; Nasir, B; Oliver, C; Smith, M, 2016
)
0.43
" Subgroup analysis indicated that the follow-up time, the dosage of folic acid and vitamin B12 and B6, the history of diseases had no confounding effect on the incidence of cardio-cerebrovascular disease events."( [Meta-analysis on effect of combined supplementation of folic acid, vitamin B12 and B6 on risk of cardio-cerebrovascular diseases in randomized control trials].
Dang, SN; Lan, X; Yan, H; Zhao, YL, 2016
)
0.43
" We also performed a random-effects dose-response meta-analysis."( Vitamin B6 and Cancer Risk: A Field Synopsis and Meta-Analysis.
Briarava, M; Mocellin, S; Pilati, P, 2017
)
0.46
" Study participants with elevated PAr experienced a higher risk of incident stroke in an essentially linear dose-response fashion."( The PAr index, an indicator reflecting altered vitamin B-6 homeostasis, is associated with long-term risk of stroke in the general population: the Hordaland Health Study (HUSK).
Meyer, K; Midttun, Ø; Nygård, O; Tell, GS; Ueland, PM; Ulvik, A; Vollset, SE; Zuo, H, 2018
)
0.48
"PAr was positively associated with lung cancer risk in a dose-response fashion."( Vitamin B6 catabolism and lung cancer risk: results from the Lung Cancer Cohort Consortium (LC3).
Albanes, D; Blot, WJ; Brennan, P; Buring, JE; Cai, Q; Caporaso, NE; Ericson, U; Fanidi, A; Freedman, ND; Gao, Y; Gaziano, JM; Giles, GG; Grankvist, K; Han, J; Hodge, A; Hultdin, J; Hveem, K; Johansson, M; Jones, MR; Koh, W; Langhammer, A; Lee, I; Marchand, LL; McCullough, ML; Midttun, Ø; Næss, M; Pettinger, M; Prentice, R; Relton, C; Severi, G; Shu, X; Stampfer, MJ; Stevens, VL; Tell, GS; Thomson, CA; Ueland, PM; Ulvik, A; Visvanathan, K; Wang, R; Weinstein, SJ; Wu, J; Xiang, Y; Yuan, J; Zeleniuch-Jacquotte, A; Zhang, X; Zheng, W; Ziegler, RG; Zuo, H, 2019
)
0.51
" No previous study has, however, designated the time of TRP dosing to improve mood."( Effect of Tryptophan, Vitamin B
Akamatsu, Y; Hayashi, T; Moritani, T; Nishida, MM; Tsujita, N, 2019
)
0.51
" Thus, in France, as in other countries, vitamin B6 could be integrated into the therapeutic arsenal of mild to moderate nausea and vomiting during pregnancy according to the following dosage schedule: oral intake of 10mg four times a day of a compounded preparation of vitamin B6, alone or in combination with doxylamine."( [Interest of vitamin b6 for treatment of nausea and/or vomiting during pregnancy].
Pecriaux, C, 2020
)
0.56
" The results indicated a non-linear dose-response relationship between vitamin B6 intake and pancreatic risk."( Vitamin B6, vitamin B12 and methionine and risk of pancreatic cancer: a meta-analysis.
Mao, QQ; Wei, DH, 2020
)
0.56
" Restricted cubic splines were plotted to evaluate the dose-response relationship between dietary OCM-related nutrient intake and the risk of PE."( One-carbon metabolism-related nutrients intake is associated with lower risk of preeclampsia in pregnant women: a matched case-control study.
Bo, Y; Cao, Y; Dou, W; Duan, D; Fu, W; Liu, Y; Lyu, Q; Ma, S; Zeng, F; Zhao, X, 2022
)
0.72
" Significant nonlinear dose-response relationships were observed for the associations of folate with anemia, vitamin B12 with vitamin B-complex deficiencies, anemia and cholelithiasis, and homocysteine with cerebrovascular disease."( Phenome-wide association study of genetically predicted B vitamins and homocysteine biomarkers with multiple health and disease outcomes: analysis of the UK Biobank.
Bennett, D; Campbell, H; Duthie, S; Eguiagaray, IM; Li, X; Little, J; MacFarlane, AJ; McNulty, H; Momoli, F; Montazeri, A; Munger, R; Rubini, M; Senekal, M; Theodoratou, E; Wang, L, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Pathways (3)

PathwayProteinsCompounds
pyridoxal 5'-phosphate salvage I519
pyridoxal 5'-phosphate biosynthesis I726
superpathway of pyridoxal 5'-phosphate biosynthesis and salvage937

Research

Studies (2,831)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990918 (32.43)18.7374
1990's5 (0.18)18.2507
2000's809 (28.58)29.6817
2010's800 (28.26)24.3611
2020's299 (10.56)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 79.59

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index79.59 (24.57)
Research Supply Index8.10 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index259.44 (26.88)
Search Engine Supply Index3.69 (0.95)

This Compound (79.59)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials259 (8.55%)5.53%
Reviews304 (10.03%)6.00%
Case Studies100 (3.30%)4.05%
Observational13 (0.43%)0.25%
Other2,354 (77.69%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (81)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayed-release Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (T [NCT03905564]Phase 10 participants (Actual)Interventional2019-06-30Withdrawn(stopped due to Sponsor decision)
PILOTSTUDIE ZUR PYRIDOXALPHOSPHATTHERAPIE BEI PATIENTEN MIT PRIMÄRER HYPEROXALURIE TYP I (PHOX-B6-PILOT) Pilot Trial on Treatment of Patients With Primary Hyperoxaluria Type I With Pyridoxal-phosphate [NCT01281878]Phase 212 participants (Actual)Interventional2010-12-31Completed
Efficacy of Risk-Targeted Video Based Directly on Observed Therapy for Latent TB [NCT03783728]0 participants (Actual)Observational2019-06-30Withdrawn(stopped due to Investigator is leaving the University)
Renal Protective Effect and Clinical Analysis of Vitamin B6 in Patients With Sepsis [NCT06008223]128 participants (Actual)Interventional2021-11-01Completed
Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial [NCT01317849]0 participants (Actual)Interventional2011-07-31Withdrawn(stopped due to financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance)
An Exploratory Single Blind Study of Ergoloid Mesylates, 5-Hydroxytryptophan, and the Combination in Adult Males With Fragile X Syndrome [NCT05030129]Phase 215 participants (Actual)Interventional2021-10-07Completed
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis [NCT03882177]Phase 216 participants (Actual)Interventional2020-02-21Completed
URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence [NCT03302299]Phase 4302 participants (Actual)Interventional2017-04-07Completed
Effects of Vitamin Supplementation and Strength Training in Parkinson's Disease [NCT01238926]40 participants (Anticipated)Interventional2008-05-31Active, not recruiting
Vitamin B6 and Magnesium on Neurobehavioral Status of Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study [NCT03963479]Phase 250 participants (Anticipated)Interventional2019-01-01Recruiting
Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial [NCT03720249]100 participants (Anticipated)Interventional2019-05-20Not yet recruiting
EARLY NUTRITIONAL INTERVENTION IN PATIENTS WITH AUTISM SPECTRUM DISORDERS [NCT01230359]40 participants (Actual)Interventional2010-04-30Completed
Effect of Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics [NCT03790345]Phase 2/Phase 345 participants (Anticipated)Interventional2019-09-03Recruiting
Pyridoxine, P2 Receptor Antagonism, and ATP-mediated Vasodilation in Young Adults [NCT03738943]Early Phase 19 participants (Actual)Interventional2019-02-07Completed
A Pilot Study of the Preoperative Misoprostol in Reducing Operative Blood Loss During Hysterectomy [NCT01199159]77 participants (Actual)Interventional2007-01-31Completed
TBTC Study 31 PK/PD: Population Pharmacokinetic and Pharmacodynamic Study of Efficacy and Safety of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis in the Study 31 Treatment Trial: Intensive PK Sampling [NCT02563327]Phase 360 participants (Anticipated)Interventional2016-05-30Recruiting
Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy [NCT00763633]Phase 4150 participants (Anticipated)Interventional2008-01-31Recruiting
A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy [NCT00767689]6 participants (Actual)Interventional2006-03-21Terminated(stopped due to incomplete enrollment)
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates [NCT05411744]Phase 425 participants (Anticipated)Interventional2022-07-01Recruiting
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients. [NCT00659269]Phase 3319 participants (Actual)Interventional2006-07-31Completed
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease [NCT00853879]150 participants (Actual)Interventional2006-12-31Terminated
Uterine Fibroids Are a Very Common Finding in Women of Reproductive Age. Ready Safety Study Extracts of Plants Pregnenolone & Pyridoxal Phosphate for Treating Uterine Fibroids in Women of Reproductive Age and Women Pregnancy. [NCT04762316]66 participants (Actual)Interventional2019-01-01Completed
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers [NCT03510468]Phase 151 participants (Actual)Interventional2018-06-12Completed
Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial [NCT02209545]Phase 447 participants (Actual)Interventional2014-10-31Terminated(stopped due to The study was prematurely closed due to low enrollment rates.)
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial [NCT05409872]108 participants (Anticipated)Interventional2022-09-15Recruiting
Evaluation of the Role of Pyridoxine Adjuvant Therapy on the Blood Glucose Level in Type 2 Diabetic Patients [NCT05918068]108 participants (Actual)Interventional2022-11-01Completed
Phase 3 Study of a Compound Natural Health Product in Children With ADHD [NCT01022229]Phase 316 participants (Actual)Interventional2013-11-30Completed
Assesment of Vitamin B6 Level in Patients With Major Depressive Disorder [NCT05649293]94 participants (Anticipated)Observational2023-04-01Not yet recruiting
The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study [NCT00704990]Phase 2/Phase 328 participants (Actual)Interventional2008-09-30Completed
Vitamin B6 Supplementation and Mood States in College Women Taking Oral Contraceptives [NCT04070391]8 participants (Actual)Interventional2019-01-01Completed
Efficacy of the Association of Hyaluronic Acid With High Molecular Weight, α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion in Patients at Risk [NCT05449171]100 participants (Anticipated)Interventional2022-09-01Recruiting
A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome [NCT02625415]54 participants (Actual)Interventional2016-07-31Completed
Protocol Comparing a Nutraceutical Formulation Consisting of Omega-3 Fatty Acids, Vitamin D, and Vitamins B6 Plus B12 Versus No Treatment in the Prevention or Reduction of Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients Treated With Docetaxe [NCT02795572]Phase 213 participants (Actual)Interventional2017-06-27Terminated(stopped due to Retirement of the Principal Investigator)
Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application [NCT02758990]16 participants (Actual)Interventional2016-03-31Terminated(stopped due to Recruiting and financial constraints)
Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia [NCT03287778]17 participants (Actual)Interventional2017-12-01Completed
Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection [NCT01404312]Phase 33,000 participants (Actual)Interventional2012-05-23Completed
Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012 [NCT01730313]Phase 20 participants (Actual)Interventional2016-02-29Withdrawn(stopped due to Did not get approval from the collaborating partners in-country)
A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome [NCT00296036]Phase 3137 participants (Actual)Interventional2006-06-30Completed
[NCT01964001]Phase 2/Phase 371 participants (Actual)Interventional2014-01-31Completed
The Treatment of Pulmonary Mycobacterium Tuberculosis in HIV Infection [NCT00001033]Phase 3650 participants InterventionalCompleted
Vitamin B6 Effects on One-Carbon Metabolism [NCT01128244]Phase 2/Phase 313 participants (Actual)Interventional2010-04-30Completed
A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study [NCT04311502]Phase 2104 participants (Actual)Interventional2021-06-16Active, not recruiting
The Early Bactericidal Activity of High-Dose or Standard-Dose Isoniazid Among Adult Participants With Isoniazid-Resistant or Drug-Sensitive Tuberculosis [NCT01936831]Phase 2282 participants (Actual)Interventional2014-08-13Completed
[NCT01426490]Phase 2/Phase 3300 participants (Anticipated)Interventional2011-08-31Recruiting
[NCT00706888]64 participants (Anticipated)InterventionalCompleted
Oral Misoprostol Before Endometrial Biopsy [NCT00200226]Phase 372 participants (Actual)Interventional2003-02-28Completed
A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome [NCT00559858]Phase 3270 participants (Anticipated)Interventional2004-12-31Active, not recruiting
Air Pollution, Epigenetics and Cardiovascular Health: A Human Intervention Trial [NCT01864824]Phase 110 participants (Actual)Interventional2013-06-30Completed
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection [NCT00000636]2,000 participants InterventionalCompleted
Neuroprotective Effect of Vitamin B12 and Vitamin B6 Against Vincristine Induced Peripheral Neuropathy: A Randomized, Double Blind, Placebo Controlled, Multi Center Trial [NCT02923388]Phase 488 participants (Actual)Interventional2016-10-31Completed
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB) [NCT03568383]Phase 35,610 participants (Anticipated)Interventional2019-06-03Recruiting
HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study) [NCT00106886]Phase 45,000 participants Interventional1999-12-31Active, not recruiting
Co-SAM: An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated Severe Acute Malnutrition [NCT05994742]Phase 31,266 participants (Anticipated)Interventional2024-03-01Not yet recruiting
Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS) [NCT00486213]Phase 3210 participants (Actual)Interventional2007-06-30Terminated(stopped due to Slow accrual)
A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) [NCT00245050]Phase 334 participants (Actual)Interventional2004-04-30Completed
Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis [NCT00000950]50 participants InterventionalCompleted
B-Vitamin Atherosclerosis Intervention Trial (BVAIT) [NCT00114400]Phase 2/Phase 3506 participants Interventional2000-11-30Completed
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection [NCT00000959]600 participants InterventionalCompleted
High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimer's Disease (Vitamins to Slow Alzheimer's - VITAL) [NCT00056225]Phase 3340 participants (Actual)Interventional2003-01-31Completed
Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI) [NCT06020300]Phase 464 participants (Anticipated)Interventional2023-07-28Recruiting
Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT) [NCT00266487]3,750 participants Interventional1998-12-31Completed
Implementation for Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals Using Novel Regimen of Isoniazid/Rifapentine Daily (4 Weeks) Compared to Isoniazid/Rifapentine Weekly (12 Weeks) [NCT03785106]Phase 32,500 participants (Anticipated)Interventional2019-08-15Recruiting
Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding (AUB) Using Sublingual Misoprostol 200 Mcg: A Randomized, Double Blind, Placebo-controlled Trial [NCT01762319]52 participants (Anticipated)Interventional2012-11-30Recruiting
A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women With Latent Tuberculosis Infection [NCT02651259]Phase 1/Phase 250 participants (Actual)Interventional2017-03-13Completed
Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder [NCT05813366]39 participants (Anticipated)Interventional2023-04-25Not yet recruiting
The Neurobehavioral and Biochemical Effects of High Dose of Vitamin B6 With Magnesium in Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Study [NCT04509401]66 participants (Actual)Interventional2020-01-11Completed
A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin [NCT00000778]Phase 144 participants InterventionalCompleted
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in [NCT00000796]525 participants InterventionalCompleted
A Single-Center, Open-Label Study to Assess the Effects of the Addition of Modulators of Homocysteine to Adalimumab Therapy in the Treatment of Moderate to Severe Plaque Psoriasis Evaluated With the PASI, PGA and DLQI [NCT01704599]Phase 1/Phase 28 participants (Actual)Interventional2009-01-31Terminated(stopped due to side effect and poor clinical outcome)
A Randomised Double Blind Study of the Effects of Homocysteine Lowering Therapy on Mortality and Cardiac Events in Patients Undergoing Coronary Angiography [NCT00354081]Phase 33,096 participants (Actual)Interventional1999-04-30Completed
Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection [NCT00000638]2,000 participants InterventionalCompleted
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS) [NCT00000541]Phase 20 participants Interventional1993-05-31Completed
The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid [NCT05448365]Phase 360 participants (Anticipated)Interventional2022-07-01Recruiting
A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy [NCT00614445]Phase 3280 participants (Actual)Interventional2008-01-31Completed
Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline- Randomized Controlled Trial [NCT05024422]89 participants (Actual)Interventional2021-12-31Completed
Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Neuroprotective Effect of Vitamin B6 and Vitamin B12 Against Vincristine Induced Neurotoxicity in Acute Lymphoblastic Leukaemia Patients [NCT03593304]Phase 2/Phase 340 participants (Actual)Interventional2018-03-29Completed
The Effects of Vitamin B-6 and Glutathione on Inflammatory Responses, Homocysteine Metabolism, Oxidative Stress and Antioxidant Capacities in Patients With Liver Cirrhosis or Hepatocellular Carcinoma [NCT02321579]25 participants (Anticipated)Interventional2014-12-31Recruiting
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder [NCT05837104]Phase 240 participants (Anticipated)Interventional2023-12-13Recruiting
Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals [NCT04272242]Phase 272 participants (Anticipated)Interventional2020-08-01Suspended(stopped due to Following completion of Arm 1, A5372 is currently Temporarily Closed. Timeline for opening of Arm 2 is not available.)
A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifampin-Based Tuberculosis Treatment Versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifabutin-Based Tuberculosis Treatment W [NCT01601626]Phase 271 participants (Actual)Interventional2013-07-13Terminated(stopped due to The study was stopped early due to feasibility concerns.)
A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients [NCT03580499]40 participants (Actual)Interventional2018-09-13Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00245050 (2) [back to overview]Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
NCT00245050 (2) [back to overview]Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)
NCT00296036 (2) [back to overview]To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia
NCT00296036 (2) [back to overview]To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream
NCT00614445 (1) [back to overview]Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).
NCT00659269 (4) [back to overview]Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 2
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 4
NCT01128244 (5) [back to overview]Fasting Plasma Cystathionine Concentration
NCT01128244 (5) [back to overview]Fasting Plasma Pyridoxal Phosphate Concentration
NCT01128244 (5) [back to overview]Flux of Homocysteine Remethylation From Serine-derived Carbon
NCT01128244 (5) [back to overview]Plasma 3-hydroxykynurenine Concentration
NCT01128244 (5) [back to overview]Total Remethylation of Homocysteine
NCT01404312 (6) [back to overview]Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
NCT01404312 (6) [back to overview]Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause
NCT01404312 (6) [back to overview]Cumulative Incidence of Death Due to a Non-TB Event
NCT01404312 (6) [back to overview]Cumulative Incidence of Death From Any Cause
NCT01404312 (6) [back to overview]Efavirenz (EFV) Plasma Concentrations in Arm A
NCT01404312 (6) [back to overview]Nevirapine (NVP) Plasma Concentrations in Arm A
NCT01601626 (26) [back to overview]Cumulative Probability of HIV Virologic Failure at Week 72
NCT01601626 (26) [back to overview]LPV AUC in Participants Enrolled in Arms A, B, and C
NCT01601626 (26) [back to overview]Number of Participants Reporting a Grade 3 or 4 Laboratory Abnormality
NCT01601626 (26) [back to overview]Number of Participants Reporting a Grade 3 or 4 Sign or Symptom
NCT01601626 (26) [back to overview]Number of Participants Who Experienced MTB IRIS
NCT01601626 (26) [back to overview]Percent of Participants Who Died
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced a New AIDS-defining Illness
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced HIV Virologic Failure
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced Sputum Conversion at Week 8.
NCT01601626 (26) [back to overview]RBT Cmax and Cmin in Participants Enrolled in Arms A and C
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced TB Relapse/Recurrence
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced TB Treatment Failure
NCT01601626 (26) [back to overview]Percent of Participants Who Interrupted or Discontinued at Least One HIV Drug Due to Toxicity
NCT01601626 (26) [back to overview]Percent of Participants Who Interrupted or Discontinued at Least One TB Drug Due to Toxicity
NCT01601626 (26) [back to overview]Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.
NCT01601626 (26) [back to overview]Percent of Participants Whose HIV Viral Load Was Less Than 50 Copies/mL at Week 48
NCT01601626 (26) [back to overview]RAL AUC in Participants Enrolled in Arm C
NCT01601626 (26) [back to overview]RBT AUC in Participants Enrolled in Arms A and C
NCT01601626 (26) [back to overview]LPV Cmax and Cmin in Participants Enrolled in Arms A, B, and C
NCT01601626 (26) [back to overview]RAL Cmax and Cmin in Participants Enrolled in Arm C
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced TB Relapse/Recurrence and Who Had TB Drug Resistance
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced a New AIDS-defining Illness or Died
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 24
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 48
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 72
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 8
NCT01704599 (24) [back to overview]Number of Participants With Category Change in Vitamin B12 Blood Level
NCT01704599 (24) [back to overview]Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)
NCT01704599 (24) [back to overview]Number of Participants With Category Change in Serum Folic Acid Level.
NCT01704599 (24) [back to overview]Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):
NCT01704599 (24) [back to overview]Number of Participants Who Fulfilled the Category of Having Height Measured
NCT01704599 (24) [back to overview]Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)
NCT01704599 (24) [back to overview]Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)
NCT01704599 (24) [back to overview]Number of Participants in the Categories of Having and Not Having an Adverse Event
NCT01704599 (24) [back to overview]Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine
NCT01704599 (24) [back to overview]EKG Categoryy Changes Related to Homocysteine Changes
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium
NCT01704599 (24) [back to overview]Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)
NCT01704599 (24) [back to overview]PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF
NCT01704599 (24) [back to overview]PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3
NCT01704599 (24) [back to overview]Number of Participants Within Categories of Body Temperature Change
NCT01704599 (24) [back to overview]Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody
NCT01704599 (24) [back to overview]Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasign and Decreasing Body Weight
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:
NCT01936831 (10) [back to overview]Daily Change in log10 Colony-forming Unit (CFU)
NCT01936831 (10) [back to overview]Daily Change in Time to Positivity (TTP)
NCT01936831 (10) [back to overview]INH PK Parameter Maximum Plasma Concentration (Cmax)
NCT01936831 (10) [back to overview]INH PK Parameter Minimum Plasma Concentration (Cmin)
NCT01936831 (10) [back to overview]Number of Participants With Grade 2 or Higher Drug-related Adverse Clinical or Laboratory Events
NCT01936831 (10) [back to overview]Proportions of Participants Estimated to Have a Drop in log10 CFU/mL at or Above 0.65 log10 CFU/mL.
NCT01936831 (10) [back to overview]Daily Change in TTP Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
NCT01936831 (10) [back to overview]INH PK Parameter Area Under the Concentration Time Curve (AUC 0-24 Hours)
NCT01936831 (10) [back to overview]INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
NCT01936831 (10) [back to overview]Daily Change in log10 CFU Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
NCT02651259 (24) [back to overview]Plasma Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants
NCT02651259 (24) [back to overview]Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT) for Intensive and Sparse PK
NCT02651259 (24) [back to overview]Volume of Distribution of INH
NCT02651259 (24) [back to overview]Volume of Distribution Relative to Bioavailability (Vc/F) for Rifapentine (RPT)
NCT02651259 (24) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC0-24) for RPT and Area Under the Curve From 0 to 24 Hours (AUC0-24) for Des-RPT Pregnant Women in 2nd and 3rd Trimester
NCT02651259 (24) [back to overview]Clearance (CL/F) of INH
NCT02651259 (24) [back to overview]Maximum Concentration (Cmax) for RPT Maximum Concentration (Cmax) for Des-RPT Pregnant Women in 2nd and 3rd Trimester
NCT02651259 (24) [back to overview]Maximum Concentration (Cmin) for RPT and Maximum Concentration (Cmin) for Des-RPT Pregnant Women in 2nd and 3rd Trimester
NCT02651259 (24) [back to overview]Plasma Concentrations of Rifapentine (RPT) Among Infants
NCT02651259 (24) [back to overview]Absorption (ka) of INH
NCT02651259 (24) [back to overview]Absorption Rate Constant (ka) for Rifapentine (RPT)
NCT02651259 (24) [back to overview]Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT)
NCT02651259 (24) [back to overview]Clearance Relative to Bioavailability (CLmet/F) for Desacetyl Rifapentine (Des-RPT)
NCT02651259 (24) [back to overview]Cord Blood Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants
NCT02651259 (24) [back to overview]Cord Blood Concentrations of Rifapentine (RPT) Among Infants
NCT02651259 (24) [back to overview]Incidence of Related Serious Adverse Events (SAEs) in Pregnant and Postpartum Women Taking Once-weekly RPT + INH
NCT02651259 (24) [back to overview]Number of Infants With Active TB up to 24 Weeks of Life
NCT02651259 (24) [back to overview]Number of Mothers With Active TB up to 24 Weeks Postpartum
NCT02651259 (24) [back to overview]Number of Participants With Discontinuation of Study Drug Due to Intolerance (Tolerability of Study Drug Regimen - i.e., RPT, INH, and Pyridoxine)
NCT02651259 (24) [back to overview]Percentage of Participants With All AEs Leading to Permanent Discontinuation of Study Drug Regimen (i.e., RPT, INH, and Pyridoxine)
NCT02651259 (24) [back to overview]Percentage of Participants With All Grade 3 and 4 AEs
NCT02651259 (24) [back to overview]Percentage of Participants With All Serious AEs
NCT02651259 (24) [back to overview]Percentage of Participants With Grade 2 Adverse Events (AEs) Judged to be Related to Study Drug Regimen
NCT02651259 (24) [back to overview]Percentage of Participants With Related Serious Adverse Events (AEs) in Infants Born to Women Taking Once-weekly RPT + INH
NCT03302299 (8) [back to overview]Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity
NCT03302299 (8) [back to overview]Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale
NCT03302299 (8) [back to overview]Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days
NCT03302299 (8) [back to overview]Percentage of Participants With Suboptimal INH Medication Adherence
NCT03302299 (8) [back to overview]INH Concentration in Hair: (INH Pmol + Acetyl INH Pmol) Per mg of Hair
NCT03302299 (8) [back to overview]Number of Participants With Latent Tuberculosis at Study Screening.
NCT03302299 (8) [back to overview]Number of Participants With Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Elevations at Study Screening
NCT03302299 (8) [back to overview]Number of Participants Who Discontinued Treatment
NCT03510468 (1) [back to overview]Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
NCT03882177 (2) [back to overview]Number of Participants Who Permanently Discontinue Assigned Study Regimen for Any Reason
NCT03882177 (2) [back to overview]Frequency of Grade 3 or Higher Adverse Events

Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)

Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific doxorubicin HCl liposome related toxicities using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. (NCT00245050)
Timeframe: Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.

,
Interventionparticipants (Number)
Grade 1 HFSGrade 2 HFSGrade 3 HFS
Placebo331
Pyridoxine233

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Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)

QOL was measured with the FACT-G questionnaire following the third course of doxorubicin HCl liposome before the patient was seen by the treating physician and before chemotherapy was administered. The FACT-G, version 4, is a 27-item core questionnaire evaluating the domains of physical, functional, family-social, and emotional well-being (PWB, FWB, SWB, EWB). Total score ranges from 0-108 and higher scores indicate better QOL. (NCT00245050)
Timeframe: After Cycle 3 of chemotherapy (on average at 3 months)

InterventionTotal scores on FACT-G scale (Mean)
Pyridoxine84.9
Placebo84.4

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To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia

A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported. (NCT00296036)
Timeframe: First 3 weeks of treatment

Interventionpercentage of participants (Number)
Urea/Lactic Acid Cream13.6
Placebo Cream10.2

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To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream

Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report. (NCT00296036)
Timeframe: Up to 4, 21-day cycles

,
Interventionparticipants (Number)
Grade 3+ Adverse EventGrade 4+ Adverse Event
Placebo Cream183
Urea/Lactic Acid Cream213

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Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).

The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe). (NCT00614445)
Timeframe: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)

InterventionPUQE Score (Mean)
Diclectin®-4.8
Placebo-3.9

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Change in Neurotoxicity Assessment Between Cycle 4 and Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm7.0
Taxane Group: MV + Vitamin B12 + Vitamin B67.2
Heavy Metals Group: Multivitamin (MV) Arm3.9
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.7
Vinca Alkaloids Group: Multivitamin (MV) Arm11.8
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm7

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Neurotoxicity Assessment at Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported. (NCT00659269)
Timeframe: At study start; prior to treatment (week 0)

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm8.5
Taxane Group: MV + Vitamin B12 + Vitamin B67.3
Heavy Metals Group: Multivitamin (MV) Arm5.23
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.58
Vinca Alkaloids Group: Multivitamin (MV) Arm6.80
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm2.08

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Neurotoxicity Assessment at Cycle 2

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm13.0
Taxane Group: MV + Vitamin B12 + Vitamin B612.0
Heavy Metals Group: Multivitamin (MV) Arm9.7
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm8.4
Vinca Alkaloids Group: Multivitamin (MV) Arm14.56
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm5.6

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Neurotoxicity Assessment at Cycle 4

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm14.5
Multivitamin + Vitamin B12 + Vitamin B614.5
Heavy Metals Group: Multivitamin (MV) Arm8.71
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm7.05
Vinca Alkaloids Group: Multivitamin (MV) Arm17.5
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm9.22

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Fasting Plasma Cystathionine Concentration

For all subjects, the concentration of plasma cystathionine in fasting blood samples taken before and after the supplementation period will provide a functional measure of vitamin B6 nutritional status. (NCT01128244)
Timeframe: Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.

Interventionmicromol/L (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Plasma Cystathionine Concentration0.140.13

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Fasting Plasma Pyridoxal Phosphate Concentration

For all subjects, the concentration of plasma pyridoxal phosphate in fasting blood samples taken before and after the supplementation period will provide a direct measure of vitamin B6 nutritional status. (NCT01128244)
Timeframe: Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.

Interventionnmol/L (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Plasma Pyridoxal Phosphate Concentration25.8143

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Flux of Homocysteine Remethylation From Serine-derived Carbon

Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of homocysteine remethylation from serine-derived carbon before and after vitamin B6 supplementation. These flux values may be slightly higher than flux of total homocysteine remethylation in Outcome Measure 1 because of the small contribution of methionine salvage to the flux measured in Outcome Measure 2. (NCT01128244)
Timeframe: Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days

Interventionmicromol/(kg x hr) (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Homocysteine Remethylation Flux From Serine6.606.92

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Plasma 3-hydroxykynurenine Concentration

For all subjects, analysis of blood samples before and after vitamin B6 supplementation will allow evaluation of discriminating biomarkers using targeted metabolite profile analysis of one-carbon metabolism and tryptophan catabolism constituents. Also, we will conduct exploratory evaluation and potential identification of new biomarkers using metabolomics analysis on subjects before and after vitamin B6 supplementation. (NCT01128244)
Timeframe: April, 2010 - June, 2014

Interventionmicrol/L (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Secondary Analysis: Plasma 3-hydroxykynurenine Concentration25.927.3

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Total Remethylation of Homocysteine

Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation. (NCT01128244)
Timeframe: Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days

Interventionmicromol/(kg x hr) (Mean)
Baseline prior to vitamin supplementationAfter 28-days of vitamin supplementation
Total Homocysteine Remethylation Flux6.075.63

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Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis

Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug. (NCT01404312)
Timeframe: After TB diagnosis

InterventionParticipants (Count of Participants)
Rifampin72268104Rifampin72268105Isoniazid72268104Isoniazid72268105Ethambutol72268104Ethambutol72268105Pyrazinamide72268104Pyrazinamide72268105
Developed ResistanceDid not Develop Resistance
RPT Plus INH Regimen (Arm A)1
INH Regimen (Arm B)1
RPT Plus INH Regimen (Arm A)14
INH Regimen (Arm B)11
RPT Plus INH Regimen (Arm A)2
RPT Plus INH Regimen (Arm A)12
RPT Plus INH Regimen (Arm A)0
RPT Plus INH Regimen (Arm A)7
INH Regimen (Arm B)7
INH Regimen (Arm B)0
RPT Plus INH Regimen (Arm A)6
INH Regimen (Arm B)6

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Cumulative Incidence of Death Due to a Non-TB Event

Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks. (NCT01404312)
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)

,
Interventionevents per 100 participants (Number)
Cumulative incidence by 1 year post-randomizationCumulative incidence by 2 years post-randomizationCumulative incidence by 3 years post-randomizationCumulative incidence by 4 years post-randomization
INH Regimen (Arm B)0.51.01.52.0
RPT Plus INH Regimen (Arm A)0.30.40.91.6

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Cumulative Incidence of Death From Any Cause

Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry. (NCT01404312)
Timeframe: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)

,
Interventionevents per 100 participants (Number)
1 year post-entry2 years post-entry3 years post-entry4 years post-entry
INH Regimen (Arm B)0.631.151.622.29
RPT Plus INH Regimen (Arm A)0.350.491.052.00

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Efavirenz (EFV) Plasma Concentrations in Arm A

"Mean and standard deviation.~Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019." (NCT01404312)
Timeframe: Measured at Weeks 0, 2, 4, and 16

Interventionnanograms per mL (Mean)
Week 0Week 2Week 4
RPT Plus INH Regimen (Arm A)378738704082

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Nevirapine (NVP) Plasma Concentrations in Arm A

Mean and standard deviation (NCT01404312)
Timeframe: Measured at Weeks 0, 2, and 4

Interventionnanograms per mL (Mean)
Week0Week 2Week 4
RPT Plus INH Regimen (Arm A)757362345797

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Cumulative Probability of HIV Virologic Failure at Week 72

Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. The percent of participants with HIV virologic failure at week 72 was calculated using a Kaplan-Meier estimator with an associated standard error. The confidence interval was calculated using a log-log transformation. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At weeks 16, 24, 48, and 72

Interventioncumulative events per 100 participants (Number)
A: Standard-dose LPV/r w/RBT29.2
B: Double-dose LPV/r w/RIF50.0
C: Standard-Dose LPV/r + RAL w/RBT30.4

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LPV AUC in Participants Enrolled in Arms A, B, and C

Describe LPV plasma PK characteristics (area under the curve [AUC] between 0 and 12 hours) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose

Interventionhours*ng/mL (Median)
A: Standard-dose LPV/r w/RBT159796
B: Double-dose LPV/r w/RIF161772
C: Standard-Dose LPV/r + RAL w/RBT149247

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Number of Participants Reporting a Grade 3 or 4 Laboratory Abnormality

The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) laboratory abnormality were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

InterventionParticipants (Count of Participants)
A: Standard-dose LPV/r w/RBT6
B: Double-dose LPV/r w/RIF3
C: Standard-Dose LPV/r + RAL w/RBT5

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Number of Participants Reporting a Grade 3 or 4 Sign or Symptom

The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) sign or symptom were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

InterventionParticipants (Count of Participants)
A: Standard-dose LPV/r w/RBT7
B: Double-dose LPV/r w/RIF5
C: Standard-Dose LPV/r + RAL w/RBT5

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Number of Participants Who Experienced MTB IRIS

The number of participants who experienced MTB immune reconstitution inflammatory syndrome (IRIS) was summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

InterventionParticipants (Count of Participants)
A: Standard-dose LPV/r w/RBT1
B: Double-dose LPV/r w/RIF2
C: Standard-Dose LPV/r + RAL w/RBT3

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Percent of Participants Who Died

The percent of participants who died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT4.2
B: Double-dose LPV/r w/RIF4.7
C: Standard-Dose LPV/r + RAL w/RBT4.3

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Percent of Participants Who Experienced a New AIDS-defining Illness

New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT0.0
B: Double-dose LPV/r w/RIF4.2
C: Standard-Dose LPV/r + RAL w/RBT0.0

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Percent of Participants Who Experienced HIV Virologic Failure

Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. Participants who were missing data due to being lost-to-follow-up or dead were coded as virologic failures. The percent of participants who experienced HIV virologic failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At weeks 16, 24, 48, and 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT29.2
B: Double-dose LPV/r w/RIF50.0
C: Standard-Dose LPV/r + RAL w/RBT30.4

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Percent of Participants Who Experienced Sputum Conversion at Week 8.

Sputum conversion was defined as culture MTB-negative at week 8 or AFB smear negative at week 8 (and culture contaminated or missing at week 8); there were no Xpert MTB/RIF results at week 8. The percent of participants experienced sputum conversion at week 8 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT87.5
B: Double-dose LPV/r w/RIF81.8
C: Standard-Dose LPV/r + RAL w/RBT70.0

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RBT Cmax and Cmin in Participants Enrolled in Arms A and C

Describe RBT plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

,
Interventionng/mL (Median)
Maximum Concentration (Cmax)Minimum Concentration (Cmin)
A: Standard-dose LPV/r w/RBT461161
C: Standard-Dose LPV/r + RAL w/RBT349115

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Percent of Participants Who Experienced TB Relapse/Recurrence

TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The percent of participants who experienced TB relapse/recurrence was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At or after 24 weeks and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT0.0
B: Double-dose LPV/r w/RIF4.2
C: Standard-Dose LPV/r + RAL w/RBT4.3

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Percent of Participants Who Experienced TB Treatment Failure

TB treatment failure was defined as having a MTB-positive culture after 16 weeks of TB treatment for a participant who was documented to be taking TB medications. The percent of participants who experienced TB treatment failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After 16 weeks and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT0.0
B: Double-dose LPV/r w/RIF0.0
C: Standard-Dose LPV/r + RAL w/RBT0.0

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Percent of Participants Who Interrupted or Discontinued at Least One HIV Drug Due to Toxicity

The percent of participants who interrupted or discontinued at least one HIV drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT20.8
B: Double-dose LPV/r w/RIF16.7
C: Standard-Dose LPV/r + RAL w/RBT21.7

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Percent of Participants Who Interrupted or Discontinued at Least One TB Drug Due to Toxicity

The percent of participants who interrupted or discontinued at least one TB drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through to the discontinuation of the last TB drug

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT20.8
B: Double-dose LPV/r w/RIF8.3
C: Standard-Dose LPV/r + RAL w/RBT13.0

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Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.

The percent of participants whose HIV viral load was less than 400 copies/mL at week 48 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. Participants who were lost-to-follow-up or dead by week 48 or had missing results at week 48 were coded as having HIV viral load greater than 400 copies/mL. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT58.3
B: Double-dose LPV/r w/RIF66.7
C: Standard-Dose LPV/r + RAL w/RBT60.9

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Percent of Participants Whose HIV Viral Load Was Less Than 50 Copies/mL at Week 48

The percent of participants whose HIV viral load was less than 50 copies/mL at week 48 was calculated with an associated standard error. Participants who were lost-to-follow-up or dead by week 48 or had missing RNA at week 48 were coded as having HIV viral load greater than 50 copies/mL. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT45.8
B: Double-dose LPV/r w/RIF54.2
C: Standard-Dose LPV/r + RAL w/RBT56.5

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RAL AUC in Participants Enrolled in Arm C

Describe RAL plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

Interventionhours*ng/mL (Median)
C: Standard-Dose LPV/r + RAL w/RBT11338

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RBT AUC in Participants Enrolled in Arms A and C

Describe RBT plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

Interventionhours*ng/mL (Median)
A: Standard-dose LPV/r w/RBT7374
C: Standard-Dose LPV/r + RAL w/RBT5516

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LPV Cmax and Cmin in Participants Enrolled in Arms A, B, and C

Describe LPV plasma pharmacokinetic (PK) characteristics (maximum concentration [Cmax] and minimum concentration [Cmin]) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose

,,
Interventionng/mL (Median)
Maximum Concentration (Cmax)Minimum Concentration (Cmin)
A: Standard-dose LPV/r w/RBT185319920
B: Double-dose LPV/r w/RIF181388033
C: Standard-Dose LPV/r + RAL w/RBT168028548

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RAL Cmax and Cmin in Participants Enrolled in Arm C

Describe RAL plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

Interventionng/mL (Median)
Maximum Concentration (Cmax)Minimum Concentration (Cmin)
C: Standard-Dose LPV/r + RAL w/RBT2830166

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Percent of Participants Who Experienced TB Relapse/Recurrence and Who Had TB Drug Resistance

TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The drug resistance was determined based on phenotypic methods. The percent of participants who experienced TB relapse/recurrence and who had TB drug resistance was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At or after 24 weeks and through week 72

Interventionparticipants (Number)
B: Double-dose LPV/r w/RIF0
C: Standard-Dose LPV/r + RAL w/RBT0

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Percent of Participants Who Experienced a New AIDS-defining Illness or Died

New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness or died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT4.2
B: Double-dose LPV/r w/RIF8.3
C: Standard-Dose LPV/r + RAL w/RBT4.3

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CD4 Count Change From Baseline to Week 24

The difference in CD4 count from baseline to week 24 was calculated as the CD4 count at week 24 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 24 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT20
B: Double-dose LPV/r w/RIF56
C: Standard-Dose LPV/r + RAL w/RBT13

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CD4 Count Change From Baseline to Week 48

The difference in CD4 count from baseline to week 48 was calculated as the CD4 count at week 48 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 48 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT99
B: Double-dose LPV/r w/RIF119
C: Standard-Dose LPV/r + RAL w/RBT74

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CD4 Count Change From Baseline to Week 72

The difference in CD4 count from baseline to week 72 was calculated as the CD4 count at week 72 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 72 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT126
B: Double-dose LPV/r w/RIF212
C: Standard-Dose LPV/r + RAL w/RBT54

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CD4 Count Change From Baseline to Week 8

The difference in CD4 count from baseline to week 8 was calculated as the CD4 count at week 8 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 8 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT7
B: Double-dose LPV/r w/RIF26
C: Standard-Dose LPV/r + RAL w/RBT37

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Number of Participants With Category Change in Vitamin B12 Blood Level

Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. (NCT01704599)
Timeframe: At Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins500

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Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)

Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high (NCT01704599)
Timeframe: At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins401

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Number of Participants With Category Change in Serum Folic Acid Level.

Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
IncreasedUnchangedDecreasedNot evaluable (if >20 ng/ml only stated as such)
Humira Then Humira Plus 3 B Vitamins3002

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Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):

Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
ImprovedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins313

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Number of Participants Who Fulfilled the Category of Having Height Measured

Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis. (NCT01704599)
Timeframe: Week 0 at Start of Adalimumab

Interventionparticipants (Number)
MeasuredNot measured
Humira Then Humira Plus 3 B Vitamins80

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Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)

An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study. (NCT01704599)
Timeframe: Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination

Interventionparticipants (Number)
NormalizingUnchangedNewly abnormal
Humira Then Humira Plus 3 B Vitamins141

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Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)

A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28. (NCT01704599)
Timeframe: By Week 16, by Week 28 and by Day 70 post Week 28.

Interventionparticipants (Number)
No SAESAE by Week 16SAE by Week 28SAE by Day 70 afterWeek 28
Humira Then Humira Plus 3 B Vitamins7100

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Number of Participants in the Categories of Having and Not Having an Adverse Event

"Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study:~AE Humira only" (NCT01704599)
Timeframe: After Week 16 of study

Interventionparticipants (Number)
No Adverse Event after Week 16Adverse Event Weeks 16-28Adverse event by Day 70 call after Week 28
Humira Then Humira Plus 3 B Vitamins241

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Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)

Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
WBC increasedWBC unchangedWBC decreasedHemoglobin/Hematocrit increasedHemoglobin/Hematocrit unchangedHemoglobin/Hematocrit decreased
Humira Then Humira Plus 3 B Vitamins302302

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Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine

Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis.. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Plus 3 B Vitamins103

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Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium

Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins122

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Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change

DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12). (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
ImprovedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins331

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Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus

Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. (NCT01704599)
Timeframe: Week 16 then Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins302

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Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level

Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis. (NCT01704599)
Timeframe: At Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins400

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Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)

Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study. (NCT01704599)
Timeframe: At screening

Interventionparticipant (Number)
NegativePositive
Humira Then Humira Plus 3 B Vitamins10

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PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF

Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
PASI improved with high VEGFPASI Worsened with high VEGFPASI Unchanged with normal VEGFPASI Improved with normal VEGFPASI Worsened with normal VEGF
Humira Then Humira Plus 3 B Vitamins12130

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Number of Participants Within Categories of Body Temperature Change

Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
increasedunchangeddecreased
Humira Then Humira Plus 3 B Vitamins221

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Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.

Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28 (NCT01704599)
Timeframe: Week 16 to Week 28 and Week 28 to post study day 70

Interventionparticipants (Number)
high titer worsenedhigh titer improved then worsened day 70normal titer improvednormal titer unchanged then improved day 70normal titer worsened
Humira Then Humira Plus 3 B Vitamins11311

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Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody

Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study. (NCT01704599)
Timeframe: Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins

Interventionparticipants (Number)
ElevatedNormal
Humira Then Humira Plus 3 B Vitamins26

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Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change

PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
ImprovedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins412

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Number of Participants Within the Categories of Increasign and Decreasing Body Weight

Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins205

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Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:

Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
Systolic BP increasedSystolic BP unchangedSystolic BP decreasedDiastolic BP increasedDiastolic BP unchangedDiastolic BP decreasedPulse increasedPulse unchangedPulse decreased
Humira Then Humira Plus 3 B Vitamins403502502

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Daily Change in log10 Colony-forming Unit (CFU)

Negative daily change in log10 CFU indicate decreases in bacterial burden over the 7 day period. Defined as EBA0-7(CFU) = [Day 7 log10 CFU per mL - baseline log10 CFU per mL]/7. The baseline measure is the mean of the pre-entry visit and entry visit sputum colony counts. (NCT01936831)
Timeframe: Measured at baseline and Day 7

Interventionlog10 CFU per mL sputum per day (Mean)
Group 1: 5mg Cohort-0.06
Group 1: 10mg Cohort-0.18
Group 1: 15mg Cohort-0.21
Group 2: 5mg Cohort-0.15

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Daily Change in Time to Positivity (TTP)

"The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the 7 day period and is therefore better.~Daily change is defined as EBA0-7(TTP) = [Day 7 TTP - Baseline TTP]/7. Baseline is the mean of the pre-entry visit and entry visit TTPs." (NCT01936831)
Timeframe: Measured at baseline and Day 7

Interventionhours per day (Mean)
Group 1: 5mg Cohort3
Group 1: 10mg Cohort8
Group 1: 15mg Cohort10
Group 2: 5mg Cohort10
Group 3: 15mg Cohort2.0
Group 3: 20mg Cohort4.6

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INH PK Parameter Maximum Plasma Concentration (Cmax)

Cmax defines maximum concentration observed over the 24 hours of the INH dosing interval. (NCT01936831)
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.

Interventionug/mL (Median)
Group 1: 5mg Cohort5.26
Group 1: 10mg Cohort10.4
Group 1: 15mg Cohort15.1
Group 2: 5mg Cohort4.55
Group 3: 15mg Cohort15
Group 3: 20mg Cohort22.15

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INH PK Parameter Minimum Plasma Concentration (Cmin)

Cmin defines minimum concentration observed over the 24 hours of the INH dosing interval. (NCT01936831)
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.

Interventionug/mL (Median)
Group 1: 5mg Cohort0.053
Group 1: 10mg Cohort0.053
Group 1: 15mg Cohort0.053
Group 2: 5mg Cohort0.053
Group 3: 15mg Cohort0.053
Group 3: 20mg Cohort0.053

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Proportions of Participants Estimated to Have a Drop in log10 CFU/mL at or Above 0.65 log10 CFU/mL.

Proportions of participants obtained through simulation using the estimated model who have a drop in log10 CFU/mL at or above the threshold of 0.65 log10 CFU/mL; 0.65 is half the drop in log10 CFU/mL observed in participants with DS-TB (Group 2) on day 7. A total of 10000 simulated pseudo-participants per arm were used based on data from the study participants. The NAT2 genotype distribution was based only on Group 1 and 2 participants since NAT2 genotype data was not available for Group 3. The simulations were run repeatedly. The point estimate of the proportion was based on the median proportion of the pseudo-individuals across the repeated simulations and the 90% confidence interval used the 5th and 95th percentiles of the proportion across the repeated simulations. (NCT01936831)
Timeframe: From baseline through day 7

Interventionproportion of simulated participants (Median)
Group 1: 5mg Cohort0.17
Group 1: 10mg Cohort0.50
Group 1: 15mg Cohort0.64
Group 2: 5mg Cohort0.88
Group 3: 15mg Cohort0.01
Group 3: 20mg Cohort0.05

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Daily Change in TTP Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models

The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the time period and is therefore better. The mean log transformed TTP are estimated using all values by fitting a biphasic regression models for each participant. The daily change over the first two days of treatment is calculated as EBA0-2 (TTP)= [Day 2 TTP - baseline TTP]/2. The daily change from Day 2 to Day 7 is calculated as EBA2-7 (TTP)= [Day 7 TTP - Day 2 TTP]/5. Baseline is the average of pre-evaluation and entry visits. (NCT01936831)
Timeframe: At baseline, day 2, and day 7

,,,,,
Interventionhours per day (Mean)
EBA(0-2)EBA(2-7)
Group 1: 10mg Cohort11.035.45
Group 1: 15mg Cohort7.3512.01
Group 1: 5mg Cohort7.781.77
Group 2: 5mg Cohort22.395.09
Group 3: 15mg Cohort2.912.69
Group 3: 20mg Cohort-1.365.45

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INH PK Parameter Area Under the Concentration Time Curve (AUC 0-24 Hours)

AUC 0-24h defines area under the concentration-time curve over the period of 24 hours post-dose, estimated through non-compartmental methods using the linear trapezoidal rule. (NCT01936831)
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.

Interventionug*hr/mL (Median)
Group 1: 5mg Cohort14.05
Group 1: 10mg Cohort53.08
Group 1: 15mg Cohort50.24
Group 2: 5mg Cohort10.47
Group 3: 15mg Cohort54.13
Group 3: 20mg Cohort70.54

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INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates

MIC are determined by phenotypic drug susceptibility testing (DST) based on spot sputum collected at Step 1 Day 0. For group 3 participants shown, MIC was tested using Thermofisher Sensititre MYCOTB plates. (NCT01936831)
Timeframe: Day 0

InterventionParticipants (Count of Participants)
0.03 μg/mL0.06 μg/mL0.12 μg/mL0.25 μg/mL0.5 μg/mL1 μg/mL2 μg/mL4 μg/mL>4 μg/mL
Step 1 Group 3 Version 3100001493

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Daily Change in log10 CFU Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models

Negative daily change in log10 CFU indicate decreases in bacterial burden over the time period. The mean CFU are estimated using all values by fitting a biphasic regression models for each participant. The daily change for the first two days of treatment was calculated as EBA0-2 (CFU)= [Day 2 log10 CFU per mL - baseline log10 CFU per mL]/2. The daily change from day 2 to day 7 was calculated as EBA2-7 (CFU)= [Day 7 log10 CFU per mL - Day 2 log10 CFU per mL]/5. Baseline is the average of pre-entry and entry visits. (NCT01936831)
Timeframe: At baseline, day 2, and day 7

,,,
Interventionlog10 CFU per mL sputum per day (Mean)
EBA(0-2)EBA(2-7)
Group 1: 10mg Cohort-0.17-0.17
Group 1: 15mg Cohort-0.13-0.25
Group 1: 5mg Cohort-0.23-0.01
Group 2: 5mg Cohort-0.41-0.07

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Plasma Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants

Plasma blood concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery - (within 3 days of life for infants).

Interventionmcg/mL (Mean)
All Cohorts5.31

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Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT) for Intensive and Sparse PK

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Calculated an average CL for all women in the 2nd trimester (cohort I) and all women in the 3rd trimester (cohort II)" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)1.4
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)1.50

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Volume of Distribution of INH

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~• Estimated a single INH Vc/F for the whole population" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL (Mean)
All Cohorts107

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Volume of Distribution Relative to Bioavailability (Vc/F) for Rifapentine (RPT)

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Estimated a single RPT Vc/F for for the whole population Note: that the mean stated below is actually the value that is obtained from a population analysis and represents a population estimate with the relative standard error" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL (Mean)
All Cohorts30.1

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Area Under the Curve From 0 to 24 Hours (AUC0-24) for RPT and Area Under the Curve From 0 to 24 Hours (AUC0-24) for Des-RPT Pregnant Women in 2nd and 3rd Trimester

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Obtained AUC by model-based integration" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

,
Interventionhour*mg/L (Mean)
AUC (0-24) for RPTAUC (0-24) for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)424.7158.7
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)406.8153.7

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Clearance (CL/F) of INH

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with 2 mixtures to characterize subpopulations based on acetylation status~Estimated a separate INH CL/F based on acetylation status (fast, slow)" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
CL/F (slow acetylators)CL/F (fast acetylators)
All Cohorts8.9832.7

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Maximum Concentration (Cmax) for RPT Maximum Concentration (Cmax) for Des-RPT Pregnant Women in 2nd and 3rd Trimester

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Obtained Cmax by model-based estimation" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

,
Interventionmg/L (Mean)
Cmax for RPTCmax for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)30.28.76
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)28.68.50

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Maximum Concentration (Cmin) for RPT and Maximum Concentration (Cmin) for Des-RPT Pregnant Women in 2nd and 3rd Trimester

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Obtained Cmin by model-based estimation" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

,
Interventionmg/L (Mean)
Cmin for RPTCmin for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)1.451.06
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)1.581.20

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Plasma Concentrations of Rifapentine (RPT) Among Infants

Plasma concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery - (within 3 days of life for infants).

Interventionmcg/mL (Mean)
All Cohorts2.47

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Absorption (ka) of INH

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~• Estimated a single absorption rate constant (ka) for the whole population" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

Interventionhr-1 (Mean)
All Cohorts1.74

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Absorption Rate Constant (ka) for Rifapentine (RPT)

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Estimated the transit compartment rate constant (ktr), which is synonymous with the absorption constant (ka), for the whole population Note that the mean stated below is actually the value that is obtained from a population analysis and represents a population estimate" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

Interventionhr-1 (Mean)
All Cohorts1.43

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Clearance Relative to Bioavailability (CL/F) for Rifapentine (RPT)

"PK parameters from postpartum women were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption~Calculated an average CL for all post-partum individuals" (NCT02651259)
Timeframe: Data used in the population PK analysis for postpartum women included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
All Cohorts1.64

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Clearance Relative to Bioavailability (CLmet/F) for Desacetyl Rifapentine (Des-RPT)

"PK parameters were determined from plasma concentration-time profiles using a nonlinear mixed effects model (version 7.4; ICON PLC, Dublin, Ireland).~Developed a 1 compartment PK model with transit compartments for oral absorption and a separate compartment for metabolite formation~Estimated a single des-RPT CLmet/F for the whole population Note: that the mean stated below is actually the value that is obtained from a population analysis and represents a population estimate with the relative standard error" (NCT02651259)
Timeframe: Data used in the population PK analysis included the intensive PK visit (pre-dose (t0) and 0.5, 1, 2. 4, 5, 8, 12, 24, 48, 72 hours post-dose) and sparse PK visit (1, 4, 24, 48 hours post-dose).

InterventionL/hr (Mean)
All Cohorts2.82

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Cord Blood Concentrations of Desacetyl Rifapentine (Des-RPT) Among Infants

Cord blood concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery (within 3 days of life for infants).

Interventionmcg/mL (Mean)
All Cohorts3.24

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Cord Blood Concentrations of Rifapentine (RPT) Among Infants

Cord blood concentrations were summarized using using R (version 3.5.1). (NCT02651259)
Timeframe: at delivery - (within 3 days of life for infants)

Interventionmcg/mL (Mean)
All Cohorts2.97

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Number of Infants With Active TB up to 24 Weeks of Life

Based on site-specified confirmatory TB test. If women and infants were diagnosed with active TB during study they would be referred to local care for TB management and treatment. (NCT02651259)
Timeframe: Measured from birth through participants' last study visit at 24 weeks after delivery

InterventionParticipants (Count of Participants)
Cohort 1(Infants Born to Women Enrolled in Second Trimester)0
Cohort 2 (Infants Born to Women Enrolled in Third Trimester)0

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Number of Mothers With Active TB up to 24 Weeks Postpartum

Based on site-specified confirmatory TB test. If women and infants were diagnosed with active TB during study they would be referred to local care for TB management and treatment. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

InterventionParticipants (Count of Participants)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)0
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)0

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Number of Participants With Discontinuation of Study Drug Due to Intolerance (Tolerability of Study Drug Regimen - i.e., RPT, INH, and Pyridoxine)

At entry and follow-up, all lab results, sign and symptoms, and diagnoses will be recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that result in discontinuation of study drug regimen, and that meet criteria for EAE reporting will be further evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

InterventionParticipants (Count of Participants)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)0
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)0

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Percentage of Participants With All AEs Leading to Permanent Discontinuation of Study Drug Regimen (i.e., RPT, INH, and Pyridoxine)

At entry and follow-up, all lab results, sign and symptoms, and diagnoses were recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that resulted in discontinuation of study drug regimen, and that met criteria for EAE reporting would further be evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study treatment dispensation (approximately for 12 weeks)

Interventionpercent of participants (Number)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)0
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)0

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Percentage of Participants With All Grade 3 and 4 AEs

At entry and follow-up, all lab results, sign and symptoms, and diagnoses were recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that resulted in discontinuation of study drug regimen, and that met criteria for EAE reporting would further be evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

Interventionpercent of participants (Number)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)20
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)16

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Percentage of Participants With All Serious AEs

At entry and follow-up, all lab results, sign and symptoms, and diagnoses were recorded. Also, during follow-up grade 2 events related to pregnancy complications, hepatotoxicity, hemorrhage, or peripheral neuropathy, and all grade 3 or events that resulted in discontinuation of study drug regimen, and that met criteria for EAE reporting would further be evaluated and recorded. The DAIDS Table for Grading Adult and Pediatric Adverse Events (V 2.0) and Expedited AE Manual (V 2.0) were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

Interventionpercent of participants (Number)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)8
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)12

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Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity

Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period. (NCT03302299)
Timeframe: Hepatotoxicity occurring during the six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.

Interventionpercent (Number)
INH and Vitamin B68.3

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Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale

The Self Rating Single Item (SRSI) adherence scale asks participants to rate their ability to take their medications as prescribed over the past 30 days. Participants reporting INH use in the prior 30 days at the 3- or 6-month interview are included here, and reported their INH adherence in the prior 30 days as excellent, very good, good, fair, poor, or very poor. (NCT03302299)
Timeframe: Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH

InterventionParticipants (Count of Participants)
At 3 months72558043At 6 months72558043
ExcellentVery goodGoodFairPoorVery poor
INH and Vitamin B6160
INH and Vitamin B679
INH and Vitamin B638
INH and Vitamin B62
INH and Vitamin B6124
INH and Vitamin B690
INH and Vitamin B641
INH and Vitamin B64
INH and Vitamin B60
INH and Vitamin B61

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Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days

"Participants were asked In the past 30 days, how many days in total have you not taken your pill? and were presented with a visual analog scale (VAS) to indicate the percentage of INH taken in the past 30 days. We converted the VAS percentage into number of days out of 30 to match the first question. Our final self-report measure was the minimum number of the 2 self-reported measurements." (NCT03302299)
Timeframe: Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH

Interventiondays (Median)
at 3 monthsat 6 months
INH and Vitamin B63030

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Percentage of Participants With Suboptimal INH Medication Adherence

Suboptimal INH adherence was defined as <90% of days with at least 1 electronic medication management (EMM) pill cap opening in the previous 90 days, at 3- and 6-months. (NCT03302299)
Timeframe: Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter)

Interventionpercentage of participants (Number)
at 3 monthsat 6 months
INH and Vitamin B631.343.9

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INH Concentration in Hair: (INH Pmol + Acetyl INH Pmol) Per mg of Hair

INH concentration in hair (pmol/mg) will be measured at 3- and 6- months during INH therapy. (NCT03302299)
Timeframe: Measured at 3- and 6- months after INH initiation

Interventionpmol/mg (Median)
at 3 monthsat 6 months
INH and Vitamin B636.037.8

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Number of Participants With Latent Tuberculosis at Study Screening.

Latent tuberculosis assessed at screening via tuberculin skin testing (TST). A TST induration >=5mm was considered positive for latent tuberculosis. (NCT03302299)
Timeframe: Study screening visit

InterventionParticipants (Count of Participants)
Study Screening308

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Number of Participants With Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Elevations at Study Screening

Alanine transaminase (ALT) or aspartate transaminase (AST) elevations (>2x the upper limit of normal) at study screening (NCT03302299)
Timeframe: Study screening visit

InterventionParticipants (Count of Participants)
Study Screening80

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Number of Participants Who Discontinued Treatment

Lack of tolerability will be defined as any isoniazid (INH) treatment discontinuation prior to completion of the prescribed course (6 months of INH taken over a maximum period of 9 months) due to side effects or alanine transaminase (ALT)/aspartate transaminase (AST) elevations. (NCT03302299)
Timeframe: Six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.

InterventionParticipants (Count of Participants)
INH and Vitamin B632

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Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)

Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of TFV was calculated using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ® (NCT03510468)
Timeframe: 0-24 hours post dosing on days 14, 22, and 31

Interventionhr*ng/ml (Geometric Mean)
Day 14Day 22Day 31
Pharmacokinetic Study in Healthy Volunteers262.2265.3230.8

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Number of Participants Who Permanently Discontinue Assigned Study Regimen for Any Reason

(Other than new recognition of participant ineligibility based on absence of M. tuberculosis growth in baseline sputum cultures, or growth of M. tuberculosis resistant to rifampin by GeneXpert) (NCT03882177)
Timeframe: Measured through Day 14

InterventionParticipants (Count of Participants)
Arm 1: Pravastatin (40 mg) and Rifafour10
Arm 2: Pravastatin (80 mg) and Rifafour6
Arm 3: Pravastatin (120 mg) and Rifafour0
Arm 4: Pravastatin (160 mg) and Rifafour0

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Frequency of Grade 3 or Higher Adverse Events

Graded using the DAIDS table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (NCT03882177)
Timeframe: Measured through Day 30

InterventionAEs Grade 3 or Higher (Number)
Arm 1: Pravastatin (40 mg) and Rifafour8
Arm 2: Pravastatin (80 mg) and Rifafour4

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