isoniazid has been researched along with Premature Birth in 2 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).
Premature Birth: CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION).
Excerpt | Relevance | Reference |
---|---|---|
"In this multicenter, double-blind, placebo-controlled, noninferiority trial, we randomly assigned pregnant women with HIV infection to receive isoniazid preventive therapy for 28 weeks, initiated either during pregnancy (immediate group) or at week 12 after delivery (deferred group)." | 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) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (50.00) | 24.3611 |
2020's | 1 (50.00) | 2.80 |
Authors | Studies |
---|---|
Quincer, EM | 1 |
Lyland, A | 1 |
Onyango, D | 1 |
LaCourse, SM | 1 |
Figueroa, J | 1 |
John-Stewart, GC | 1 |
Cranmer, LM | 1 |
Gupta, A | 1 |
Montepiedra, G | 1 |
Aaron, L | 1 |
Theron, G | 1 |
McCarthy, K | 1 |
Bradford, S | 1 |
Chipato, T | 1 |
Vhembo, T | 1 |
Stranix-Chibanda, L | 1 |
Onyango-Makumbi, C | 1 |
Masheto, GR | 1 |
Violari, A | 1 |
Mmbaga, BT | 1 |
Aurpibul, L | 1 |
Bhosale, R | 1 |
Mave, V | 1 |
Rouzier, V | 1 |
Hesseling, A | 1 |
Shin, K | 1 |
Zimmer, B | 1 |
Costello, D | 1 |
Sterling, TR | 1 |
Chakhtoura, N | 1 |
Jean-Philippe, P | 1 |
Weinberg, A | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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 | |||
[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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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 |
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.
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 |
1 trial available for isoniazid and Premature Birth
Article | Year |
---|---|
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women.
Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method | 2019 |
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women.
Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method | 2019 |
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women.
Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method | 2019 |
Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women.
Topics: Adolescent; Adult; AIDS-Related Opportunistic Infections; Antitubercular Agents; Double-Blind Method | 2019 |
1 other study available for isoniazid and Premature Birth
Article | Year |
---|---|
The effect of antenatal isoniazid preventive therapy on birth outcomes in Western Kenya.
Topics: Female; HIV Infections; Humans; Infant, Newborn; Isoniazid; Kenya; Perinatal Death; Pregnancy; Prema | 2023 |