isoniazid and Pregnancy studies

Hydra: A genus of freshwater polyps in the family Hydridae, order Hydroida, class HYDROZOA. They are of special interest because of their complex organization and because their adult organization corresponds roughly to the gastrula of higher animals.
hydrazide : Compounds derived from oxoacids RkE(=O)l(OH)m (l =/= 0) by replacing -OH by -NRNR2 (R groups are commonly H). (IUPAC).

Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.

Research Excerpts

Excerpt	Relevance	Reference
" Of 749 infants, 694 (93%) received Bacille Calmette-Guérin (BCG) vaccination, 675 (90%) were born to mothers who had completed isoniazid treatment, 20 (3%) were exposed to tuberculosis, seven (1%) became HIV positive, and one (<1%) developed probable tuberculosis."	9.69	Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial. ( Aaron, L; Bradford, S; Chakhtoura, N; Chanaiwa, V; Chipato, T; Costello, D; Golner, A; Gupta, A; Jean-Phillippe, P; Kabugho, E; Kulkarni, V; Masheto, G; Montepiedra, G; Mutambanengwe, M; Raesi, M; Shayo, A; Singh, P; Sterling, TR; Stranix-Chibanda, L; Theron, G; Vhembo, T; Weinberg, A, 2023)
" Rifapentine clearance is higher among women with HIV, but all women achieved exposures of rifapentine and isoniazid associated with successful tuberculosis prevention."	9.51	Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women. ( Bradford, S; Britto, P; Chakhtoura, N; Chalermchockcharoentkit, A; Chipato, T; Dooley, KE; Gupta, A; Jayachandran, P; Kamthunzi, P; Langat, D; Mathad, JS; Montepiedra, G; Norman, J; Patil, S; Popson, S; Rouzier, V; Savic, R; Townley, E; Wiesner, L; Zhang, N, 2022)
"International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1078, a randomized noninferiority study designed to compare the safety of starting isoniazid preventive therapy (IPT) in women living with human immunodeficiency virus (HIV) either during pregnancy or after delivery, showed that IPT during pregnancy increased the risk of composite adverse pregnancy outcomes, but not individual outcomes."	9.41	Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus. ( Aaron, L; Chakhtoura, N; Chipato, T; Gupta, A; Jean-Philippe, P; Lespinasse, D; Loftis, AJ; Masheto, G; McCarthy, K; Montepiedra, G; Nematadzira, T; Ngocho, J; Nyati, M; Onyango-Makumbi, C; Patil, S; Theron, G; Tongprasert, F; Weinberg, A; Zimmer, B, 2021)
"While 6- to 12-month courses of isoniazid for tuberculosis prevention are considered safe in pregnant women, the effects of longer-term isoniazid prophylaxis or isoniazid in combination with antiretroviral therapy (ART) are not established in human-immunodeficiency-virus-(HIV-) infected women who experience pregnancy during the course of therapy."	9.17	Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy. ( Mathebula, U; Mathoma, A; Moathlodi, R; Mosimaneotsile, B; Samandari, T; Taylor, AW; Theebetsile, I, 2013)
" Isoniazid preventive therapy (IPT) has been used globally for this purpose for many years, including in pregnancy."	9.05	The safety of isoniazid tuberculosis preventive treatment in pregnant and postpartum women: systematic review and meta-analysis. ( Falzon, D; Figueroa, C; Hamada, Y; Kanchar, A; Martín-Sánchez, M, 2020)
"Isoniazid preventive therapy (IPT) against tuberculosis (TB) is a life-saving intervention for people living with HIV (PLHIV)."	8.02	Early-phase scale-up of isoniazid preventive therapy for people living with HIV in two districts in Malawi (2017). ( Auld, AF; Gunde, LJ; Jahn, A; Kirking, HL; Maida, A; Nabity, SA; Nyirenda, RK; Odo, M; Oeltmann, JE; Shiraishi, RW; Surie, D, 2021)
"The World Health Organization recommends isoniazid preventive therapy (IPT) for people living with HIV (PLHIV) to prevent tuberculosis (TB), including pregnant women."	7.91	Brief Report: High Programmatic Isoniazid Preventive Therapy (IPT) Use in Pregnancy Among HIV-Infected Women. ( Copeland, A; Cranmer, LM; John-Stewart, G; Kinuthia, J; LaCourse, SM; Maleche-Obimbo, E; Matemo, D; Richardson, BA; Wagner, AD, 2019)
"The Lesotho Ministry of Health issued guidelines on active case finding (ACF) for tuberculosis (TB) and isoniazid preventive therapy (IPT) in April 2011."	7.80	Preventing tuberculosis among HIV-infected pregnant women in Lesotho: the case for rolling out active case finding and isoniazid preventive therapy. ( Ahimbisibwe, A; Barnes, GL; Chaisson, RE; Gounder, CR; Guay, L; Isavwa, A; Kassaye, S; Maama-Maime, LB; Machekano, R; Mokone, M; Ntene-Sealiete, K; Oyebanji, O; Sahu, M; Tiam, A, 2014)
"Pregnancy is accompanied by immune suppression."	7.01	Effects of Pregnancy and Isoniazid Preventive Therapy on Mycobacterium tuberculosis Interferon Gamma Response Assays in Women With HIV. ( Aaron, L; Bradford, S; Browning, R; Costello, D; Denti, P; Gausi, K; Gupta, A; Haas, DW; Kabugho, E; LaCourse, SM; Masheto, G; Mathad, JS; McCarthy, K; Mmbaga, B; Montepiedra, G; Naik, S; Pahwa, S; Pierre, MF; Sterling, TR; Theron, G; Vhembo, T; Weinberg, A; Zimmer, B, 2021)
" To address this knowledge gap, we used physiologically based pharmacokinetic (PBPK) modeling to evaluate NAT2 phenotype-specific effects of pregnancy on INH disposition."	5.91	Application of a physiologically based pharmacokinetic model to predict isoniazid disposition during pregnancy. ( Amaeze, OU; Isoherranen, N, 2023)
" Of 749 infants, 694 (93%) received Bacille Calmette-Guérin (BCG) vaccination, 675 (90%) were born to mothers who had completed isoniazid treatment, 20 (3%) were exposed to tuberculosis, seven (1%) became HIV positive, and one (<1%) developed probable tuberculosis."	5.69	Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial. ( Aaron, L; Bradford, S; Chakhtoura, N; Chanaiwa, V; Chipato, T; Costello, D; Golner, A; Gupta, A; Jean-Phillippe, P; Kabugho, E; Kulkarni, V; Masheto, G; Montepiedra, G; Mutambanengwe, M; Raesi, M; Shayo, A; Singh, P; Sterling, TR; Stranix-Chibanda, L; Theron, G; Vhembo, T; Weinberg, A, 2023)
"We report pregnancy outcomes among South African women with HIV enrolled in a randomized trial of 4 TPT regimens (two 3-month regimens, rifapentine/isoniazid [3HP] or rifampin/isoniazid [3HR], isoniazid for 6 months, or isoniazid continuously)."	5.51	Pregnancy in Women With HIV in a Tuberculosis Preventive Therapy Trial. ( Barnes, GL; Chaisson, RE; Gupta, A; Martinson, NA; Moulton, LH; Msandiwa, R; Singh, P, 2022)
" Rifapentine clearance is higher among women with HIV, but all women achieved exposures of rifapentine and isoniazid associated with successful tuberculosis prevention."	5.51	Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women. ( Bradford, S; Britto, P; Chakhtoura, N; Chalermchockcharoentkit, A; Chipato, T; Dooley, KE; Gupta, A; Jayachandran, P; Kamthunzi, P; Langat, D; Mathad, JS; Montepiedra, G; Norman, J; Patil, S; Popson, S; Rouzier, V; Savic, R; Townley, E; Wiesner, L; Zhang, N, 2022)
"International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1078, a randomized noninferiority study designed to compare the safety of starting isoniazid preventive therapy (IPT) in women living with human immunodeficiency virus (HIV) either during pregnancy or after delivery, showed that IPT during pregnancy increased the risk of composite adverse pregnancy outcomes, but not individual outcomes."	5.41	Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus. ( Aaron, L; Chakhtoura, N; Chipato, T; Gupta, A; Jean-Philippe, P; Lespinasse, D; Loftis, AJ; Masheto, G; McCarthy, K; Montepiedra, G; Nematadzira, T; Ngocho, J; Nyati, M; Onyango-Makumbi, C; Patil, S; Theron, G; Tongprasert, F; Weinberg, A; Zimmer, B, 2021)
"The risks associated with initiation of isoniazid preventive therapy during pregnancy appeared to be greater than those associated with initiation of therapy during the postpartum period."	5.30	Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. ( Aaron, L; Aurpibul, L; Bhosale, R; Bradford, S; Chakhtoura, N; Chipato, T; Costello, D; Gupta, A; Hesseling, A; Jean-Philippe, P; Masheto, GR; Mave, V; McCarthy, K; Mmbaga, BT; Montepiedra, G; Onyango-Makumbi, C; Rouzier, V; Shin, K; Sterling, TR; Stranix-Chibanda, L; Theron, G; Vhembo, T; Violari, A; Weinberg, A; Zimmer, B, 2019)
"To assess safety and pregnancy outcomes among pregnant women who were inadvertently exposed to study medications in two latent tuberculosis infection trials (PREVENT TB or iAdhere) evaluating 3HP and 9 months of daily isoniazid (H, 300 mg) (9H)."	5.27	Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials. ( Belknap, RW; Chaisson, RE; Goldberg, SV; Leung, CC; Lopez, M; Machado, ES; Moro, RN; Narita, M; Sanchez, J; Schluger, NW; Schwartzman, K; Scott, NA; Sterling, TR; Tepper, NK; Vernon, A; Villarino, ME, 2018)
"To reduce the risk of tuberculosis (TB) among individuals with human immunodeficiency virus (HIV) infection, the World Health Organization recommends at least 6 months of isoniazid preventive therapy (IPT)."	5.27	Predictors of isoniazid preventive therapy completion among adults newly diagnosed with HIV in rural Malawi. ( Barnes, GL; Chaisson, RE; Corbett, EL; Dowdy, DW; Khundi, M; Little, KM; Makombe, S; Ngwira, LG; Nkhoma, A, 2018)
"While 6- to 12-month courses of isoniazid for tuberculosis prevention are considered safe in pregnant women, the effects of longer-term isoniazid prophylaxis or isoniazid in combination with antiretroviral therapy (ART) are not established in human-immunodeficiency-virus-(HIV-) infected women who experience pregnancy during the course of therapy."	5.17	Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy. ( Mathebula, U; Mathoma, A; Moathlodi, R; Mosimaneotsile, B; Samandari, T; Taylor, AW; Theebetsile, I, 2013)
"The roles of the NAT2 genotype and enzyme maturation on isoniazid pharmacokinetics were investigated in South African infants with perinatal HIV exposure enrolled in a randomized, double-blind, controlled trial of isoniazid for prevention of tuberculosis disease and latent infection."	5.16	The pharmacogenetics of NAT2 enzyme maturation in perinatally HIV exposed infants receiving isoniazid. ( D'Argenio, DZ; Fletcher, CV; Kiser, JJ; Mitchell, CD; Seifart, HI; Werely, CJ; Zhu, R, 2012)
" Isoniazid preventive therapy (IPT) has been used globally for this purpose for many years, including in pregnancy."	5.05	The safety of isoniazid tuberculosis preventive treatment in pregnant and postpartum women: systematic review and meta-analysis. ( Falzon, D; Figueroa, C; Hamada, Y; Kanchar, A; Martín-Sánchez, M, 2020)
"Isoniazid (INH) has been the mainstay of treatment of latent tuberculosis infection for almost 50 years."	4.86	Treatment of latent tuberculosis infection: An update. ( Lobue, P; Menzies, D, 2010)
"Isoniazid preventive therapy (IPT) against tuberculosis (TB) is a life-saving intervention for people living with HIV (PLHIV)."	4.02	Early-phase scale-up of isoniazid preventive therapy for people living with HIV in two districts in Malawi (2017). ( Auld, AF; Gunde, LJ; Jahn, A; Kirking, HL; Maida, A; Nabity, SA; Nyirenda, RK; Odo, M; Oeltmann, JE; Shiraishi, RW; Surie, D, 2021)
"Isoniazid preventive therapy (IPT) is widely used to protect against tuberculosis (TB) in people living with human immunodeficiency virus (HIV)."	3.96	Safety and Effectiveness of Isoniazid Preventive Therapy in Pregnant Women Living with Human Immunodeficiency Virus on Antiretroviral Therapy: An Observational Study Using Linked Population Data. ( Boulle, A; Cohen, K; Davies, MA; de Waal, R; Heekes, A; Jacob, N; Kalk, E; Maartens, G; Mehta, U; Myer, L, 2020)
"The World Health Organization recommends isoniazid preventive therapy (IPT) for people living with HIV (PLHIV) to prevent tuberculosis (TB), including pregnant women."	3.91	Brief Report: High Programmatic Isoniazid Preventive Therapy (IPT) Use in Pregnancy Among HIV-Infected Women. ( Copeland, A; Cranmer, LM; John-Stewart, G; Kinuthia, J; LaCourse, SM; Maleche-Obimbo, E; Matemo, D; Richardson, BA; Wagner, AD, 2019)
"In pregnant women who have been exposed to tuberculosis (TB), primary isoniazid prophylaxis is only recommended in cases of immunosuppression, chronic medical conditions or obstetric risk factors, and close and sustained contact with a patient with infectious TB."	3.81	[Spanish Society for Pediatric Infectious Diseases guidelines on tuberculosis in pregnant women and neonates (ii): Prophylaxis and treatment]. ( Baquero-Artigao, F; de la Calle Fernández-Miranda, M; del Rosal Rabes, T; Goncé Mellgren, A; Mellado Peña, MJ; Navarro Gómez, ML; Noguera Julián, A, 2015)
"The Lesotho Ministry of Health issued guidelines on active case finding (ACF) for tuberculosis (TB) and isoniazid preventive therapy (IPT) in April 2011."	3.80	Preventing tuberculosis among HIV-infected pregnant women in Lesotho: the case for rolling out active case finding and isoniazid preventive therapy. ( Ahimbisibwe, A; Barnes, GL; Chaisson, RE; Gounder, CR; Guay, L; Isavwa, A; Kassaye, S; Maama-Maime, LB; Machekano, R; Mokone, M; Ntene-Sealiete, K; Oyebanji, O; Sahu, M; Tiam, A, 2014)
"The purpose of this study was to evaluate whether non-US-born pregnant women receiving prenatal care are targeted for treatment of latent tuberculosis (TB) infection (LTBI) with isoniazid (INH) to prevent active TB."	3.73	Tuberculosis prevention for non-US-born pregnant women. ( DeHovitz, JA; Driver, CR; Munsiff, SS; Pfeiffer, MR; Sackoff, JE; Streett, LS, 2006)
"To study the human teratogenic potential of isoniazid and other anti-tuberculosis drug treatment during pregnancy."	3.71	A population-based case-control study of the safety of oral anti-tuberculosis drug treatment during pregnancy. ( Czeizel, AE; Olsen, J; Rockenbauer, M; Sørensen, HT, 2001)
"Using a Markov decision-analysis model, the following three strategies were evaluated for treatment of latent tuberculosis infection in pregnancy, defined as positive tuberculin skin reaction of 10 mm or greater and negative chest radiograph: no treatment, antepartum isoniazid administration, in which women were given 300 mg of isoniazid with pyridoxine beginning at 20 weeks' gestation for 6 months; and postpartum isoniazid, in which women were given isoniazid and pyridoxine for 6 months after delivery."	3.70	Antepartum or postpartum isoniazid treatment of latent tuberculosis infection. ( Boggess, KA; Hamilton, CD; Myers, ER, 2000)
"Treatment of tuberculosis: A 6-month regimen consisting of isoniazid, rifampin, and pyrazinamide given for 2 months followed by isoniazid and rifampin for 4 months is effective treatment in patients with fully susceptible organisms who comply with the treatment regimen."	3.67	American Thoracic Society. Medical Section of the American Lung Association: Treatment of tuberculosis and tuberculosis infection in adults and children. ( , 1986)
"The existence of a spermine oxidizing enzyme was established in human pregnancy serum by a radiochemical method, and a cross-sectional study of its quantitative profile between 10 and 40 weeks gestation was undertaken."	3.66	Polyamine oxidase activity in human pregnancy serum. ( Illei, G; Morgan, DM, 1979)
" Extracted parameters included bioavailability for oral drugs, volume of distribution (Vd) and clearance (CL), trough and peak drug concentrations, time of maximum concentration, area under the curve and half-life, probability of target attainment, and minimal inhibitory concentration (MIC)."	3.01	The Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy: Part III Non-penicillin and Non-cephalosporin Drugs. ( Groen, F; Hooge, MNL; Kosterink, JGW; Mian, P; Prins, JR; Touw, DJ; Winter, HLJ, 2023)
" We investigated pregnancy-induced and pharmacogenetic-associated pharmacokinetic changes and drug-drug interactions between isoniazid and efavirenz in pregnant women."	3.01	Pharmacokinetics and Drug-Drug Interactions of Isoniazid and Efavirenz in Pregnant Women Living With HIV in High TB Incidence Settings: Importance of Genotyping. ( Aaron, L; Aurpibul, L; Bhosale, R; Bradford, S; Browning, R; Chakhtoura, N; Chanaiwa, V; Chipato, T; Costello, D; Denti, P; Gausi, K; Gupta, A; Haas, DW; Hesseling, A; Jean-Philippe, P; Kabugho, E; Masheto, GR; McCarthy, K; Mhembere, T; Mmbaga, BT; Montepiedra, G; Mutambanengwe, M; Nevrekhar, N; Norman, J; Nyati, M; Onyango-Makumbi, C; Rouzier, V; Shin, K; Sterling, TR; Stranix-Chibanda, L; Theron, G; Tongprasert, F; Vhembo, T; Violari, A; Wallis, CL; Weinberg, A; Wiesner, L; Zimmer, B, 2021)
"Pregnancy is accompanied by immune suppression."	3.01	Effects of Pregnancy and Isoniazid Preventive Therapy on Mycobacterium tuberculosis Interferon Gamma Response Assays in Women With HIV. ( Aaron, L; Bradford, S; Browning, R; Costello, D; Denti, P; Gausi, K; Gupta, A; Haas, DW; Kabugho, E; LaCourse, SM; Masheto, G; Mathad, JS; McCarthy, K; Mmbaga, B; Montepiedra, G; Naik, S; Pahwa, S; Pierre, MF; Sterling, TR; Theron, G; Vhembo, T; Weinberg, A; Zimmer, B, 2021)
"The epidemiology of tuberculosis has changed dramatically over the past 5 years with significant shifts in at-risk populations, resulting in increased disease among young adults and children, especially among those from developing countries."	2.41	Congenital tuberculosis: a rare manifestation of a common infection. ( Smith, KC, 2002)
"Congenital factor XIII deficiency is a rare disease, but has provided valuable information on the physiological role of factor XIII and the benefit of factor XIII replacement therapy."	2.39	Factor XIII deficiency: pathogenic mechanisms and clinical significance. ( Egbring, R; Kröniger, A; Seitz, R, 1996)
"Rifampin is a potent antituberculous drug."	2.35	Rifampin. ( Dorken, E; Grzybowski, S; Schonell, M, 1972)
" To address this knowledge gap, we used physiologically based pharmacokinetic (PBPK) modeling to evaluate NAT2 phenotype-specific effects of pregnancy on INH disposition."	1.91	Application of a physiologically based pharmacokinetic model to predict isoniazid disposition during pregnancy. ( Amaeze, OU; Isoherranen, N, 2023)
"Despite efforts to detect and treat active tuberculosis (TB) at the border, 75% of all active TB cases diagnosed in our hospital were illegal migrants."	1.42	Preventing tuberculosis transmission at a maternity hospital by targeted screening radiography of migrants. ( Abu-Hanna, J; Aviram, G; Braun, T; Carmeli, Y; Grisaru-Soen, G; Lessing, JB; Schechner, V, 2015)
"A smear positive pulmonary tuberculosis mother with productive cough was diagnosed on the fifth day of admission."	1.38	Outcome of neonates exposed to active pulmonary tuberculosis. ( Jirapradittha, J; Kiatchoosakun, P; Saengnipanthkul, S, 2012)
"When active tuberculosis is identified, combination therapy with isoniazid, rifampin, pyrazinamide, and ethambutol should be promptly initiated for a two-month "intensive phase," and in most cases, followed by isoniazid and a rifamycin product for a four- to seven-month "continuation phase."	1.35	Update on the treatment of tuberculosis. ( Inge, LD; Wilson, JW, 2008)
" Results from the HA assay indicated that the minimal affective concentrations of citrinin required to elicit a toxic response in the adult hydra (MACA) and in the regenerating hydra (MACD) were 30 mg/l and 20 mg/l, respectively."	1.29	Evaluation of the developmental toxicity of citrinin using Hydra attenuata and postimplantation rat whole embryo culture. ( Edwards, JF; Mayura, K; Phillips, TD; Spainhour, CB; Yang, YG, 1993)
"Three patients presenting with tuberculous lymphadenitis during pregnancy are described."	1.28	Reactivation of tuberculous lymphadenitis during pregnancy. ( Khoo, SH; Warner, TT; Wilkins, EG, 1992)
"She tested positive and suspected pneumocystosis (later confirmed) and began treatment with IV Septrin and hydrocortisone."	1.28	A maternal death caused by AIDS. Case report. ( Barton, SE; Gazzard, B; Kell, PD; Marwood, RP; Nelson, M; Smith, DE, 1991)
" Only a single dosage level was studied, and the data obtained from the assay do not provide sufficient information to meet the minimum requirements of safety evaluations submitted for regulatory review."	1.27	Currently used alternatives to the Chernoff-Kavlock short-term in vivo reproductive toxicity assay. ( Christian, MS; Hoberman, AM; Lochry, EA, 1987)
" Uniform practice was found with regard to the dosage of isoniazid administered, duration of treatment, and most other indications for preventive therapy recommended by the American Thoracic Society and the U."	1.26	Tuberculosis chemoprophylaxis practices in metropolitan clinics. ( Brewin, A; Gibert, J; Herskowitz, D; Leff, A, 1979)
"Two specific illnesses, pulmonary tuberculosis and epilepsy, were investigated."	1.26	Childhood cancer and drugs in pregnancy. ( Draper, GJ; Sanders, BM, 1979)
"Urogenital tuberculosis has not decreased in incidence like other forms of tuberculosis and this is not to be expected in the coming years."	1.25	[Present status and treatment of urogenital tuberculosis]. ( Haubensak, K; Osterhage, HR, 1975)
"About 10% of the patients had active pulmonary tuberculosis immediately before or during gestation."	1.25	Pregnancy and pulmonary tuberculosis. ( David, S; Fuchs, FF; Schaefer, G; Zervoudakis, IA, 1975)

Research

Studies (262)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Incidence Rate of Combined Endpoint, Antepartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE

Timeframe	Studies, this research(%)	All Research%
pre-1990	177 (67.56)	18.7374
1990's	15 (5.73)	18.2507
2000's	15 (5.73)	29.6817
2010's	31 (11.83)	24.3611
2020's	24 (9.16)	2.80

Authors	Studies
Shady, NW	2
Farouk, HA	2
Sallam, HF	2
Haghighi, L	2
Mohabbatian, B	1
Najmi, Z	1
Rokhgireh, S	1
Saadatjoo, S	1
Moradi, Y	1
Mokhtari, M	1
Singh, P	2
Moulton, LH	1
Barnes, GL	3
Gupta, A	10
Msandiwa, R	2
Chaisson, RE	6
Martinson, NA	1
Mandima, P	1
Baltrusaitis, K	1
Montepiedra, G	8
Aaron, L	6
Mathad, J	1
Onyango-Makumbi, C	4
Nyati, M	3
Ngocho, J	2
Chareka, G	1
Ponatshego, P	1
Masheto, G	4
McCarthy, K	5
Jean-Philippe, P	4
Stranix-Chibanda, L	4
Groen, F	1
Prins, JR	1
Hooge, MNL	1
Winter, HLJ	1
Kosterink, JGW	1
Touw, DJ	1
Mian, P	1
Chipato, T	5
Chanaiwa, V	2
Vhembo, T	4
Mutambanengwe, M	2
Raesi, M	1
Bradford, S	5
Golner, A	1
Costello, D	4
Kulkarni, V	1
Shayo, A	1
Kabugho, E	3
Jean-Phillippe, P	1
Chakhtoura, N	5
Sterling, TR	5
Theron, G	6
Weinberg, A	5
Amaeze, OU	1
Isoherranen, N	1
Quincer, EM	1
Lyland, A	1
Onyango, D	1
LaCourse, SM	3
Figueroa, J	1
John-Stewart, GC	1
Cranmer, LM	3
Wagner, AD	1
Copeland, A	1
Maleche-Obimbo, E	1
Richardson, BA	1
Matemo, D	1
Kinuthia, J	2
John-Stewart, G	2
Masheto, GR	2
Violari, A	2
Mmbaga, BT	2
Aurpibul, L	2
Bhosale, R	2
Mave, V	1
Rouzier, V	3
Hesseling, A	2
Shin, K	2
Zimmer, B	4
Salazar-Austin, N	1
Cohn, S	2
Lala, S	1
Waja, Z	1
Dooley, KE	3
Hoffmann, CJ	1
Martinson, N	3
Adeniyi, OV	1
Selanto-Chairman, N	1
Owolabi, EO	1
Ajayi, AI	1
Kayembe, DK	1
Ter Goon, D	1
Gordana, A	1
Lambert, J	1
Rao, A	1
Nayak, G	1
Kumari, S	1
Kalthur, SG	1
Mutalik, SP	1
Mutalik, S	1
Adiga, SK	1
Kalthur, G	1
Cornish, EF	1
Hudson, J	1
Sayers, R	1
Loveday, M	1
Kalk, E	1
Heekes, A	1
Mehta, U	1
de Waal, R	1
Jacob, N	1
Cohen, K	1
Myer, L	1
Davies, MA	1
Maartens, G	1
Boulle, A	1
Tiendrebeogo, T	1
Anglaret, X	1
Becquet, R	1
Hamada, Y	1
Figueroa, C	1
Martín-Sánchez, M	1
Falzon, D	1
Kanchar, A	1
Browning, R	2
Mmbaga, B	1
Naik, S	1
Pahwa, S	1
Mathad, JS	2
Pierre, MF	1
Gausi, K	2
Denti, P	3
Haas, DW	2
Wiesner, L	3
Norman, J	2
Wallis, CL	1
Nevrekhar, N	1
Mhembere, T	1
Tongprasert, F	2
Loftis, AJ	1
Nematadzira, T	1
Patil, S	2
Lespinasse, D	1
Wang, X	1
Zhang, Y	1
Lin, X	1
Fu, Y	1
Sun, Q	1
Li, J	1
Liu, X	1
Bai, J	1
Orazulike, N	1
Sharma, JB	2
Sharma, S	2
Umeora, OUJ	1
Nabity, SA	1
Gunde, LJ	1
Surie, D	1
Shiraishi, RW	1
Kirking, HL	1
Maida, A	1
Auld, AF	1
Odo, M	1
Jahn, A	1
Nyirenda, RK	1
Oeltmann, JE	1
Wang, Y	1
Shao, R	1
He, C	1
Chen, L	1
Savic, R	1
Britto, P	1
Jayachandran, P	1
Zhang, N	1
Townley, E	1
Popson, S	1
Langat, D	1
Chalermchockcharoentkit, A	1
Kamthunzi, P	1
McIlleron, H	1
Mashabela, F	1
Hoffmann, JD	1
Shembe, S	1
Velaphi, S	2
Lala, SG	1
Moro, RN	1
Scott, NA	1
Vernon, A	1
Tepper, NK	1
Goldberg, SV	1
Schwartzman, K	1
Leung, CC	1
Schluger, NW	1
Belknap, RW	1
Narita, M	1
Machado, ES	1
Lopez, M	1
Sanchez, J	1
Villarino, ME	1
Little, KM	1
Khundi, M	1
Ngwira, LG	1
Nkhoma, A	1
Makombe, S	1
Corbett, EL	1
Dowdy, DW	2
Lin, S	1
Guan, W	1
LaZhou, C	1
Shi, Y	1
Kim, HY	1
Hanrahan, CF	1
Golub, JE	1
Sharma, E	1
Dharmendra, S	1
Hill, WC	1
Paruolo, JB	1
Giovino, AC	1
Pisu, MG	1
Boero, G	1
Garau, A	1
Casula, C	1
Cisci, S	1
Biggio, F	1
Concas, A	1
Follesa, P	1
Maciocco, E	1
Porcu, P	1
Serra, M	1
Taylor, AW	1
Mosimaneotsile, B	1
Mathebula, U	1
Mathoma, A	1
Moathlodi, R	1
Theebetsile, I	1
Samandari, T	1
Tiam, A	1
Machekano, R	1
Gounder, CR	1
Maama-Maime, LB	1
Ntene-Sealiete, K	1
Sahu, M	1
Isavwa, A	1
Oyebanji, O	1
Ahimbisibwe, A	1
Mokone, M	1
Guay, L	1
Kassaye, S	1
Grisaru-Soen, G	2
Savyon, M	1
Sadot, E	1
Schechner, V	2
Sivan, Y	1
Schwartz, D	1
Tarabeia, J	1
Amitai, Z	1
Yoabov, I	1
Carmeli, Y	2
Mohabatian, B	1
Baquero-Artigao, F	1
Mellado Peña, MJ	1
del Rosal Rabes, T	1
Noguera Julián, A	1
Goncé Mellgren, A	1
de la Calle Fernández-Miranda, M	1
Navarro Gómez, ML	1
Seung, KJ	1
Keshavjee, S	1
Rich, ML	1
Lessing, JB	1
Braun, T	1
Abu-Hanna, J	1
Aviram, G	1
Kapoor, S	1
Shah, M	1
Mathivha, KT	1
Langat, A	1
Ronen, K	1
McGrath, CJ	1
LaCourse, S	1
Pintye, J	1
Odeny, B	1
Singa, B	1
Katana, A	1
Nganga, L	1
Luewan, S	1
Bunmaprasert, T	1
Chiengthong, K	1
Tongsong, T	1
Inge, LD	1
Wilson, JW	1
Kittisupamongkol, W	1
Lobue, P	1
Menzies, D	1
Wibaux, C	1
Andrei, I	1
Paccou, J	1
Philippe, P	1
Biver, E	1
Duquesnoy, B	1
Flipo, RM	1
Guo, WJ	1
Shieh, GR	1
Chen, SL	1
Singh, V	1
Patra, S	1
Kulshrestha, V	1
Kriplani, A	1
Agarwal, N	1
Singh, UB	1
Rana, T	1
Zhu, R	1
Kiser, JJ	1
Seifart, HI	1
Werely, CJ	1
Mitchell, CD	1
D'Argenio, DZ	1
Fletcher, CV	1
Kuwabara, K	1
Lee, CH	1
Wang, JD	1
Chen, PC	1
Saengnipanthkul, S	1
Jirapradittha, J	1
Kiatchoosakun, P	1
Garg, K	1
Mohapatra, PR	1
Bergeron, KG	1
Bonebrake, RG	1
Allen, C	1
Gray, CJ	1
RENOVANZ, HD	1
SCHATTMANN, K	1
RUGGERI, E	1
MARRAS, G	1
BROMBERG, YM	1
SALZBERGER, M	1
BRUDERMAN, I	1
ABOULKER, P	1
MUHLRAD, S	1
PYE, A	1
GUERIN, RA	1
MINTZ, M	1
BARLOW, CF	1
SCHOOLAR, JC	1
ROTH, LJ	1
KNAPP, A	1
GASSMANN, B	1
ZIMMERMANN, W	1
PIKE, RL	1
KIRKSEY, A	1
MOYA, F	1
THORNDIKE, V	1
ZOLCINSKI, A	1
HEIMRATH, T	1
RZUCIDLO, Z	1
VARPELA, E	2
MATTILA, A	1
POULSON, E	1
ROBSON, JM	1
GUSEV, VA	1
LOWE, CR	1
SANCHEZYLLADES, L	1
SILNITSKII, PA	1
PERMSKAIA, VA	1
PELTOKALLIO, P	1
PELTOKALLIO, V	1
MACCARINI, PA	1
AGUZZOLI, RS	1
PI-SUNYER, J	1
CUTHBERT, J	1
BRUCE, LG	1
DEVI, PK	1
MUJUMDAR, SS	1
MOKADAM, NG	1
MENON, CR	1
GAWAI, TB	1
GALLOWAY, RK	1
FOSSATI, C	1
GRACEY, L	1
HESS, M	1
OGIER, E	1
FERABOLI, M	2
Choudhary, J	1
Mubarik, M	1
Parvez, A	1
Naikoo, MA	1
Stakhanov, VA	1
Makarov, OV	1
Kaiukova, SI	1
Chernousova, LN	1
Borisova, MI	1
Slastnikova, EB	1
Nakanishi, N	1
Moritaka, T	1
Ueda, N	1
Schram, AJ	1
Holm, JP	1
van Altena, R	1
Sackoff, JE	1
Pfeiffer, MR	1
Driver, CR	1
Streett, LS	1
Munsiff, SS	1
DeHovitz, JA	1
Mikami, R	1
Hammond, EC	1
Selikoff, IJ	1
Robitzek, EH	1
Schaefer, G	2
Marcus, JC	1
Tuman, KJ	1
Chilcote, RR	1
Berkow, RI	1
Moohr, JW	1
Brock, PG	1
Roach, M	1
Bhide, SV	5
Maru, GB	2
Mate, NB	1
Menon, M	1
Gangadharan, P	1
Menon, MM	3
Fujii, K	1
Watanabe, M	1
Pickwell, SM	1
Skakun, NP	1
Shman'ko, VV	1
Snider, D	1
Bilynskiĭ, BT	1
Shparik, IaV	1
Jones, FL	1
Stober, T	1
Anstätt, T	1
Schimrigk, K	1
Landschulz, W	2
Thesleff, I	1
Ekblom, P	2
Meyrick Thomas, RH	1
Rowland Payne, CM	1
Black, MM	1
Hyland, RN	1
Snider, DE	1
Layde, PM	1
Johnson, MW	1
Lyle, MA	1
Benatar, SR	1
Atkins, JN	1
Miceli, JN	1
Olson, WA	1
Cohen, SN	4
Elizondo Elizondo, F	1
González Briseño, MR	1
Rincón Castañeda, R	1
Thomas del Río, G	1
Hinojosa Garza, S	1
Junosza-Szaniawska, J	1
Wierzba, K	1
Stallworth, JR	1
Brasfield, DM	1
Tiller, RE	1
Waterfill, DB	1
Templeton, WC	1
Raff, MJ	1
Melo, JC	1
Wall, MA	1
Greth, A	1
Flamand, JR	1
Delhomme, A	1
Verduin, PR	1
Giacchino, R	1
Tasso, L	1
Losurdo, G	1
Castagnola, E	1
Olliaro, P	1
Egbring, R	1
Kröniger, A	1
Seitz, R	1
Yue, Y	1
Yang, Q	1
Zhang, S	1
Boggess, KA	1
Myers, ER	1
Hamilton, CD	1
Fisch, P	1
Handgretinger, R	1
Schaefer, HE	1
James, JS	1
Czeizel, AE	1
Rockenbauer, M	1
Olsen, J	1
Sørensen, HT	1
Smith, KC	1
Nanda, S	1
Agarwal, U	1
Sangwan, K	1
Warkany, J	1
Mcclure, HM	1
Wilk, AL	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Novel TB Prevention Regimens for HIV-Infected Adults[NCT00057122]	Phase 3	1,148 participants (Actual)	Interventional	2002-09-30	Completed
A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High Tuberculosis (TB) Incidence Setting[NCT01494038]	Phase 4	956 participants (Actual)	Interventional	2014-08-19	Completed
TB Screening Improves Preventive Therapy Uptake Trial[NCT04557176]		1,719 participants (Actual)	Interventional	2020-11-16	Active, not recruiting
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 2	50 participants (Actual)	Interventional	2017-03-13	Completed
TBTC Study 26: Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months Versus Daily Isoniazid for 9 Months for the Treatment of Latent Tuberculosis Infection[NCT00023452]	Phase 3	8,053 participants (Actual)	Interventional	2001-06-30	Completed
TBTC Study 33. An Evaluation of Adherence to Latent Tuberculosis Infection (LTBI) Treatment With 12 Doses of Once Weekly Rifapentine (RPT) and Isoniazid (INH) Given as Self-administered (SAT) Versus Directly-observed Therapy (DOT): iAdhere.[NCT01582711]	Phase 3	1,002 participants (Actual)	Interventional	2012-09-30	Completed
A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana[NCT00164281]	Phase 4	2,000 participants (Actual)	Interventional	2004-11-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata (NCT01494038)
Timeframe: Measured from study entry through end of pregnancy

Incidence Rate of Combined Endpoint, up to 12 Weeks Postpartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	15.93
Arm B (Deferred INH Treatment)	13.79

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through 12 weeks after birth

Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	16.98
Arm B (Deferred INH Treatment)	10.09

Incidence rate, calculated by Mantel-Haenszel (MH), weighted by gestational age strata 1) gestational age at entry less than 24 weeks or 2) gestational age at entry greater than or equal to 24 weeks. AE's include laboratory results, signs/symptoms, or diagnoses; graded as per Division of AIDS (DAIDS) or by protocol-defined hepatotoxicity measures. Related to treatment indicates possibly, probably, or definitely related to INH or Placebo for INH as judged by Independent Endpoint Review Committee. Discontinuation refers to permanent discontinuation of study treatment. (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Incidence Rate of Combined Endpoints: Infant TB or Infant Death

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	15.03
Arm B (Deferred INH Treatment)	14.93

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Incidence Rate of Combined Endpoints: Maternal TB or Maternal Death

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	2.99
Arm B (Deferred INH Treatment)	4.68

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Incidence Rate of Combined Endpoints: Maternal TB, Maternal Death, Infant TB, or Infant Death

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	1.00
Arm B (Deferred INH Treatment)	1.38

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Incidence Rate of Infant Death

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	3.42
Arm B (Deferred INH Treatment)	4.72

Incidence rate was calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Incidence Rate of Maternal Deaths

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	2.99
Arm B (Deferred INH Treatment)	4.42

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through Week 48 postpartum

Incidence Rate of TB Infection Among Mothers

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	0.40
Arm B (Deferred INH Treatment)	0.78

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB infection, as judged by Secondary Endpoint Review Committee (NCT01494038)
Timeframe: Measured from study entry to Week 48 after birth

Incidence Rate of Tuberculosis (TB) Among Infants

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	0.60
Arm B (Deferred INH Treatment)	0.59

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB, or congenital TB as defined using the Cantwell criteria (see reference), judged by the Secondary Endpoint Review Committee. Includes an infant death due to unknown cause. (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Incidence Rate, Antepartum, of Grade 3 or Higher AE

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	0.54
Arm B (Deferred INH Treatment)	0.52

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through end of pregnancy

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Any Cause

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	56.36
Arm B (Deferred INH Treatment)	50.88

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through delivery

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	1.77
Arm B (Deferred INH Treatment)	2.59

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Hepatotoxicity definition as defined by DAIDS AE grading criteria 1.0. (NCT01494038)
Timeframe: Measured from study entry through delivery

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by Protocol-specific Definition of Hepatotoxicity, Related to Treatment

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	1.77
Arm B (Deferred INH Treatment)	2.59

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. Protocol-specific definition of hepatotoxicity: Any one of the following: 1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of normal (ULN), where ULN is specified by the clinic physician; 2) Total bilirubin > 3 X ULN; 3) ALT greater than 3 X ULN and total bilirubin greater than 2 X ULN; or 4) ALT > 3 X ULN and persistent symptomatic clinical hepatitis (NCT01494038)
Timeframe: Measured from study entry through delivery

Incidence Rate, Antepartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	1.77
Arm B (Deferred INH Treatment)	2.59

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through delivery

Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	1.77
Arm B (Deferred INH Treatment)	2.59

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through 12 weeks postpartum

Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Related to Treatment

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	8.37
Arm B (Deferred INH Treatment)	4.98

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata (NCT01494038)
Timeframe: Measured from study entry through 12 weeks postpartum

Incidence Rate, up to 12 Weeks Postpartum, of Grade 3 or Higher AE

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	7.91
Arm B (Deferred INH Treatment)	4.52

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study entry through 12 weeks postpartum

Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Any Cause

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	56.48
Arm B (Deferred INH Treatment)	40.59

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. (NCT01494038)
Timeframe: Measured from study start through 12 weeks postpartum

Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	8.37
Arm B (Deferred INH Treatment)	4.98

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata (NCT01494038)
Timeframe: Measured from study start through 12 weeks postpartum

Number of Infants Hospitalized

Intervention	events per 100 person-years (Number)
Arm A (Immediate INH Treatment)	7.91
Arm B (Deferred INH Treatment)	4.52

Hospitalization due to reasons other than birth (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Number of Infants With Grade 3 or Higher Clinical or Laboratory AE

Intervention	Participants (Count of Participants)
Arm A (Immediate INH Treatment)	73
Arm B (Deferred INH Treatment)	75

Laboratory, sign/symptom, or diagnoses graded as 3 or higher by DAIDS criteria. (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment

Intervention	Participants (Count of Participants)
Arm A (Immediate INH Treatment)	193
Arm B (Deferred INH Treatment)	196

As before, but AE is judged to be possibly, probably, or definitely related to INH or Placebo for INH, by clinic medical staff (NCT01494038)
Timeframe: Measured from study entry through Week 48 after birth

Number of Mothers With a Fetal Death

Intervention	Participants (Count of Participants)
Arm A (Immediate INH Treatment)	5
Arm B (Deferred INH Treatment)	6

Fetal deaths include both stillbirths and spontaneous abortions; in case of a multiple birth, mothers who had at least one fetal death (NCT01494038)
Timeframe: Measured from study entry through end of pregnancy

Number of Mothers With an Infant Born Prematurely

Intervention	Participants (Count of Participants)
Arm A (Immediate INH Treatment)	17
Arm B (Deferred INH Treatment)	9

Premature birth is defined as gestational age of < 37 weeks at delivery. (NCT01494038)
Timeframe: Measured at delivery

Number of Mothers With Tuberculosis Resistant to INH

Intervention	Participants (Count of Participants)
Arm A (Immediate INH Treatment)	48
Arm B (Deferred INH Treatment)	40

Resistance to INH from isolates of Mycobacterium tuberculosis, as a percentage of mothers who develop culture-confirmed TB (NCT01494038)
Timeframe: Measured from study entry through Week 48 postpartum

Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve (AUC24h), for EFV

Intervention	Participants (Count of Participants)
Arm A (Immediate INH Treatment)	1
Arm B (Deferred INH Treatment)	0

Pharmacokinetic parameter was estimated from population PK modeling fitted to the intensive PK data. AUC0-24h was predicted using population pharmacokinetic model using the NONMEM software program. A 2-compartment model with first-order absorption with transit compartment and first-order elimination with well-stirred liver model to capture hepatic clearance and first-pass extraction with 1 parameter (hepatic intrinsic clearance) was used, (NCT01494038)
Timeframe: Measured at antepartum (third trimester and >= 2 weeks after starting study drug) and week 16 postpartum (+/-) 4 weeks) while on active INH; blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dosing.

Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve of Plasma Concentration Versus Time (AUC24h), for INH

Intervention	hour*mg/L (Mean)
	Third trimester of pregnancy	Week 16 postpartum
Fast Metabolizers	38.5	46.9
Intermediate Metabolizers	62.5	76.2
Slow Metabolizers	153.02	186

Absorption (ka) of INH

Intervention	hour*mg/L (Mean)
	Third trimester of pregnancy	Week 16 postpartum
Fast Metabolizers	3.63	4.25
Intermediate Metabolizers	6.55	7.67
Slow Metabolizers	21.6	25.3

"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).

Absorption Rate Constant (ka) for Rifapentine (RPT)

Intervention	hr-1 (Mean)
All Cohorts	1.74

"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).

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

Intervention	hr-1 (Mean)
All Cohorts	1.43

"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).

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

Intervention	L/hr (Mean)
All Cohorts	1.64

"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).

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

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

"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).

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

Intervention	L/hr (Mean)
All Cohorts	2.82

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

Cord Blood Concentrations of Rifapentine (RPT) Among Infants

Intervention	mcg/mL (Mean)
All Cohorts	3.24

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

Incidence of Related Serious Adverse Events (SAEs) in Pregnant and Postpartum Women Taking Once-weekly RPT + INH

Intervention	mcg/mL (Mean)
All Cohorts	2.97

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 entry through participants' last study visit at 24 weeks after delivery

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

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

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

Number of Mothers With Active TB up to 24 Weeks Postpartum

Intervention	Participants (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

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

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

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

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

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

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

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)

Percentage of Participants With All Grade 3 and 4 AEs

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

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

Percentage of Participants With All Serious AEs

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

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

Percentage of Participants With Grade 2 Adverse Events (AEs) Judged to be Related to Study Drug Regimen

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

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) and were used. (NCT02651259)
Timeframe: Measured from study entry through participants' last study visit at 24 weeks after delivery

Percentage of Participants With Related Serious Adverse Events (AEs) in Infants Born to Women Taking Once-weekly RPT + INH

Intervention	percent of participants (Number)
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)	4
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)	0

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 birth through infants' last study visit at 24 weeks after birth

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

Intervention	percent of participants (Number)
Cohort 1 (Infants Born to Women Enrolled in Second Trimester)	0
Cohort 2 (Infants Born to Women Enrolled in Third Trimester)	0

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

Plasma Concentrations of Rifapentine (RPT) Among Infants

Intervention	mcg/mL (Mean)
All Cohorts	5.31

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

Volume of Distribution of INH

Intervention	mcg/mL (Mean)
All Cohorts	2.47

"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).

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).

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).

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).

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).

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).

Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment

Cumulative TB disease rate was defined as number of participants (regardless of age) with culture-confirmed TB disease (defined as positive culture for MTB]) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB, or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach). (NCT00023452)
Timeframe: Baseline up to 33 Months

Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment

Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 33 months after enrollment (for those who completed therapy within 33 months) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach). (NCT00023452)
Timeframe: Baseline up to Month 33

Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy

Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach). (NCT00023452)
Timeframe: Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)

Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment

Cumulative TB disease rate defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for Mycobacterium tuberculosis [MTB]) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, computed tomography [CT] scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for acid-fast bacilli [AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants with (w/)33 months of follow-up calculated using survival analysis methods (Kaplan-Meier approach). (NCT00023452)
Timeframe: Baseline up to Month 33

Percentage of Participants Who Completed the Treatment Regimen

Completion in the 3RPT/INH arm was defined as: received 12 doses of RPT/INH within 16 weeks (12 weeks optimal). However, participants were considered to have completed therapy if at least 11 doses of RPT/INH had been received (~90%) during the 16-week time period. Completion in the 9INH arm was defined as: received 270 doses of INH within 52 weeks (39 weeks optimal). However, participants were considered to have completed therapy if at least 240 doses of INH were received (~90%) during the 52-week period. (NCT00023452)
Timeframe: Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)

Percentage of Participants With Death Due to Any Cause

Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH

Discontinuation of study drug due to an adverse drug reaction associated with either 3RPT/INH or 9INH was defined as discontinuing treatment and/or study due to a treatment-related adverse event (AE) (considered either possibly, probably, or definitely related to the study drug by the investigator). (NCT00023452)
Timeframe: Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])

Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH

Drug discontinuations for any reason associated with 3RPT/INH or 9INH included all reasons for discontinuation from study treatment, regardless of relationship to treatment. (NCT00023452)
Timeframe: Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)

Percentage of Participants With Resistance to Study Medications in Isolates of MTB From Participants Who Developed Active TB Disease Within 33 Months of Enrollment

Drug-susceptibility testing (DST) was performed on isolates of MTB obtained from participants who developed signs and symptoms of active TB disease (including sputum specimens or specimens from appropriate body site for extrapulmonary TB disease). DST was performed at site's local laboratory and sent to Sponsor for confirmatory susceptibility testing. DST included all drugs currently used to treat TB disease, including pyrazinamide (PZA) and fluoroquinolones. Susceptibility was tested for other drugs at the Sponsor laboratory at the following concentrations: INH, 0.02, 1.0, and 5.0 micrograms per milliliter (µg/mL) and rifampin (RIF), 1.0 µg/mL. Isolates resistant to RIF were assumed to be resistant to RPT. (NCT00023452)
Timeframe: Baseline up to Month 33

Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH

Drug toxicities (or AEs) were graded using Common Toxicity Criteria (CTC version 2.0, Publish Date April 30, 1999, Cancer Therapy Evaluation Program). Grade 3 and 4 drug toxicities associated with 3RPT/INH or 9INH were defined as treatment-related Grade 3 or 4 AEs (considered either possibly, probably, or definitely related to the study drug by the investigator). (NCT00023452)
Timeframe: Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])

Intervention	hour*mg/L (Mean)
	AUC (0-24) for RPT	AUC (0-24) for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)	424.7	158.7
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)	406.8	153.7

Intervention	L/hr (Mean)
	CL/F (slow acetylators)	CL/F (fast acetylators)
All Cohorts	8.98	32.7

Intervention	mg/L (Mean)
	Cmax for RPT	Cmax for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)	30.2	8.76
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)	28.6	8.50

Intervention	mg/L (Mean)
	Cmin for RPT	Cmin for des-RPT
Cohort 1 (Pregnant Women Enrolled in the Second Trimester)	1.45	1.06
Cohort 2 (Pregnant Women Enrolled in the Third Trimester)	1.58	1.20

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The Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy: Part III Non-penicillin and Non-cephalosporin Drugs. Clinical pharmacokinetics, 2023, Volume: 62, Issue:3 Topics: Anti-Bacterial Agents; Cephalosporins; Clindamycin; Female; Humans; Isoniazid; Penicillins; Pregnanc	2023
The safety of isoniazid tuberculosis preventive treatment in pregnant and postpartum women: systematic review and meta-analysis. The European respiratory journal, 2020, Volume: 55, Issue:3 Topics: Female; Humans; Infant, Low Birth Weight; Infant, Newborn; Isoniazid; Postpartum Period; Pregnancy;	2020
Tuberculosis (TB) in pregnancy - A review. European journal of obstetrics, gynecology, and reproductive biology, 2021, Volume: 259 Topics: Antitubercular Agents; Female; Humans; Infant, Newborn; Isoniazid; Pregnancy; Tuberculosis; Tubercul	2021
Emerging progress on diagnosis and treatment of female genital tuberculosis. The Journal of international medical research, 2021, Volume: 49, Issue:5 Topics: Antitubercular Agents; Female; Humans; Infertility, Female; Isoniazid; Mycobacterium tuberculosis; P	2021
Female genital tuberculosis: Revisited. The Indian journal of medical research, 2018, Volume: 148, Issue:Suppl Topics: Biopsy; Endoscopy; Ethambutol; Fallopian Tubes; Female; Humans; Isoniazid; Mycobacterium tuberculosi	2018
Multidrug-Resistant Tuberculosis and Extensively Drug-Resistant Tuberculosis. Cold Spring Harbor perspectives in medicine, 2015, Apr-27, Volume: 5, Issue:9 Topics: Antitubercular Agents; Child; Coinfection; Community Health Services; Drug Administration Schedule;	2015
Treatment of latent tuberculosis infection: An update. Respirology (Carlton, Vic.), 2010, Volume: 15, Issue:4 Topics: Adult; Aged; Aged, 80 and over; AIDS-Related Opportunistic Infections; Animals; Antitubercular Agent	2010
Latent tuberculosis in pregnancy: screening and treatment. Current women's health reports, 2003, Volume: 3, Issue:4 Topics: Antibiotics, Antitubercular; Antitubercular Agents; Chemical and Drug Induced Liver Injury, Chronic;	2003
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Article	Year
A randomized double blinded clinical trial to explore the clinical outcomes of vaginal isonicotinic acid hydrazide (INH) administration six hours prior to T380A intrauterine device insertion in persons delivered only by cesarean delivery. Contraception, 2023, Volume: 120 Topics: Administration, Intravaginal; Cesarean Section; Double-Blind Method; Female; Humans; Intrauterine De	2023
Isonicotinic acid hydrazide (INH) versus extra-amniotic saline infusion (EASI) for cervical ripening at term: a randomised controlled trial. Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2022, Volume: 42, Issue:7 Topics: Administration, Intravaginal; Cervical Ripening; Female; Humans; Isoniazid; Labor, Induced; Misopros	2022
Pregnancy in Women With HIV in a Tuberculosis Preventive Therapy Trial. Journal of acquired immune deficiency syndromes (1999), 2022, 12-01, Volume: 91, Issue:4 Topics: Antitubercular Agents; Contraceptive Agents; Drug Administration Schedule; Drug Therapy, Combination	2022
Prevalence of neurotoxicity symptoms among postpartum women on isoniazid preventive therapy and efavirenz-based treatment for HIV: an exploratory objective of the IMPAACT P1078 randomized trial. BMC pregnancy and childbirth, 2023, Jan-17, Volume: 23, Issue:1 Topics: Antitubercular Agents; Female; HIV Infections; Humans; Isoniazid; Postpartum Period; Pregnancy; Prev	2023
A randomized double blinded clinical trial to explore the clinical outcomes of vaginal isonicotinic acid hydrazide (INH) administration six hours prior to T380A intrauterine device insertion in persons delivered only by cesarean delivery. Contraception. 2 Contraception, 2023, Volume: 120 Topics: Cesarean Section; Female; Humans; Intrauterine Devices; Isoniazid; Pregnancy	2023
Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial. The Lancet. Child & adolescent health, 2023, Volume: 7, Issue:10 Topics: Antitubercular Agents; BCG Vaccine; Female; HIV Infections; Humans; Infant; Isoniazid; Pregnancy; Tu	2023
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. The New England journal of medicine, 2019, 10-03, Volume: 381, Issue:14 Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method	2019
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. The New England journal of medicine, 2019, 10-03, Volume: 381, Issue:14 Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method	2019
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. The New England journal of medicine, 2019, 10-03, Volume: 381, Issue:14 Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method	2019
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. The New England journal of medicine, 2019, 10-03, Volume: 381, Issue:14 Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method	2019
Effects of Pregnancy and Isoniazid Preventive Therapy on Mycobacterium tuberculosis Interferon Gamma Response Assays in Women With HIV. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021, 11-02, Volume: 73, Issue:9 Topics: Female; HIV Infections; Humans; Interferon-gamma; Interferon-gamma Release Tests; Isoniazid; Latent	2021
Pharmacokinetics and Drug-Drug Interactions of Isoniazid and Efavirenz in Pregnant Women Living With HIV in High TB Incidence Settings: Importance of Genotyping. Clinical pharmacology and therapeutics, 2021, Volume: 109, Issue:4 Topics: Adolescent; Adult; Alkynes; Anti-HIV Agents; Antitubercular Agents; Arylamine N-Acetyltransferase; B	2021
Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021, 06-01, Volume: 72, Issue:11 Topics: Adolescent; Child; Female; HIV; HIV Infections; Humans; Infant, Newborn; Isoniazid; Pregnancy; Pregn	2021
Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022, 05-03, Volume: 74, Issue:9 Topics: Adult; Antitubercular Agents; Child; Drug Therapy, Combination; Female; HIV Infections; Humans; Ison	2022
Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials. Annals of the American Thoracic Society, 2018, Volume: 15, Issue:5 Topics: Adolescent; Adult; Antitubercular Agents; Dose-Response Relationship, Drug; Drug Administration Sche	2018
Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials. Annals of the American Thoracic Society, 2018, Volume: 15, Issue:5 Topics: Adolescent; Adult; Antitubercular Agents; Dose-Response Relationship, Drug; Drug Administration Sche	2018
Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials. Annals of the American Thoracic Society, 2018, Volume: 15, Issue:5 Topics: Adolescent; Adult; Antitubercular Agents; Dose-Response Relationship, Drug; Drug Administration Sche	2018
Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials. Annals of the American Thoracic Society, 2018, Volume: 15, Issue:5 Topics: Adolescent; Adult; Antitubercular Agents; Dose-Response Relationship, Drug; Drug Administration Sche	2018
Predictors of isoniazid preventive therapy completion among adults newly diagnosed with HIV in rural Malawi. The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2018, 04-01, Volume: 22, Issue:4 Topics: Adolescent; Adult; Antitubercular Agents; Female; HIV Infections; Humans; Isoniazid; Kaplan-Meier Es	2018
Cost-effectiveness of universal isoniazid preventive therapy among HIV-infected pregnant women in South Africa. The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2018, 12-01, Volume: 22, Issue:12 Topics: Adolescent; Adult; Antitubercular Agents; Cost-Benefit Analysis; Female; HIV Infections; Humans; Int	2018
Pregnancy outcomes in HIV-infected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy. Infectious diseases in obstetrics and gynecology, 2013, Volume: 2013 Topics: Adult; AIDS-Related Opportunistic Infections; Analysis of Variance; Antibiotic Prophylaxis; Antitube	2013
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Genital tuberculosis among infertile women and fertility outcome after antitubercular therapy. International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2011, Volume: 113, Issue:3 Topics: Adult; Antitubercular Agents; Drug Therapy, Combination; Ethambutol; Female; Fertilization; Humans;	2011
The pharmacogenetics of NAT2 enzyme maturation in perinatally HIV exposed infants receiving isoniazid. Journal of clinical pharmacology, 2012, Volume: 52, Issue:4 Topics: Administration, Oral; Age Factors; Antitubercular Agents; Arylamine N-Acetyltransferase; Child, Pres	2012
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[Effects of rifampicin on the menstrual cycle and on oestrogen excretion in patients taking oral contraceptives]. Deutsche medizinische Wochenschrift (1946), 1973, Aug-11, Volume: 98, Issue:33 Topics: Adolescent; Adult; Clinical Trials as Topic; Contraceptives, Oral; Estriol; Estrogens; Estrone; Etha	1973
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isoniazid and Pregnancy

Research Excerpts

Research

Studies (262)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Incidence Rate of Combined Endpoint, Antepartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE

Incidence Rate of Combined Endpoint, up to 12 Weeks Postpartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE

Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment

Incidence Rate of Combined Endpoints: Infant TB or Infant Death

Incidence Rate of Combined Endpoints: Maternal TB or Maternal Death

Incidence Rate of Combined Endpoints: Maternal TB, Maternal Death, Infant TB, or Infant Death

Incidence Rate of Infant Death

Incidence Rate of Maternal Deaths

Incidence Rate of TB Infection Among Mothers

Incidence Rate of Tuberculosis (TB) Among Infants

Incidence Rate, Antepartum, of Grade 3 or Higher AE

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Any Cause

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by Protocol-specific Definition of Hepatotoxicity, Related to Treatment

Incidence Rate, Antepartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause

Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause

Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Related to Treatment

Incidence Rate, up to 12 Weeks Postpartum, of Grade 3 or Higher AE

Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Any Cause

Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment

Number of Infants Hospitalized

Number of Infants With Grade 3 or Higher Clinical or Laboratory AE

Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment

Number of Mothers With a Fetal Death

Number of Mothers With an Infant Born Prematurely

Number of Mothers With Tuberculosis Resistant to INH

Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve (AUC24h), for EFV

Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve of Plasma Concentration Versus Time (AUC24h), for INH

Absorption (ka) of INH

Absorption Rate Constant (ka) for Rifapentine (RPT)

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

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

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

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

Cord Blood Concentrations of Rifapentine (RPT) Among Infants

Incidence of Related Serious Adverse Events (SAEs) in Pregnant and Postpartum Women Taking Once-weekly RPT + INH

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

Number of Mothers With Active TB up to 24 Weeks Postpartum

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

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

Percentage of Participants With All Grade 3 and 4 AEs

Percentage of Participants With All Serious AEs

Percentage of Participants With Grade 2 Adverse Events (AEs) Judged to be Related to Study Drug Regimen

Percentage of Participants With Related Serious Adverse Events (AEs) in Infants Born to Women Taking Once-weekly RPT + INH

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

Plasma Concentrations of Rifapentine (RPT) Among Infants

Volume of Distribution of INH

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

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

Clearance (CL/F) of INH

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

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

Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment

Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment

Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy

Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment

Percentage of Participants Who Completed the Treatment Regimen

Percentage of Participants With Death Due to Any Cause

Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH

Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH

Percentage of Participants With Resistance to Study Medications in Isolates of MTB From Participants Who Developed Active TB Disease Within 33 Months of Enrollment

Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH

Reviews

Trials

Other Studies