Trial · NCT01494038
Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
NCT01494038, Phase 4, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2018-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women. Trials, record NCT01494038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01494038
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
- NCT number
- NCT01494038
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 956 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections, Tuberculosis
- Interventions
- Isoniazid (INH), Placebo for isoniazid (INH)
- First posted
- 2011-12-16
- Last updated
- 2021-11-05
- Results first posted
- 2018-11-20
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment | Measured from study entry through Week 48 after birth | 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. |
| Secondary | Number of Mothers With a Fetal Death | Measured from study entry through end of pregnancy | Fetal deaths include both stillbirths and spontaneous abortions; in case of a multiple birth, mothers who had at least one fetal death |
| Secondary | Number of Mothers With a Fetus Small for Gestational Age | Measured at delivery | Small for gestational age was determined by physician at site |
| Secondary | Number of Mothers With an Infant Born Prematurely | Measured at delivery | Premature birth is defined as gestational age of \< 37 weeks at delivery. |
| Secondary | Number of Mothers With a Low Birth-weight Infant | Measured on day of birth | Low birth weight is defined as weight \< 2500 mg |
| Secondary | Number of Mothers With an Infant With a Congenital Anomaly | Measured from study entry through Week 48 after birth | Includes congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria. |
| Secondary | Number of Mothers With an Adverse Pregnancy Outcome: Spontaneous Abortion, Stillbirth, Premature Birth, Low Birth Weight, or Congenital Anomaly | Measured from study entry through Week 48 after birth | In case of a multiple birth, mothers who had at least one adverse pregnancy outcome. Spontaneous abortion is intra-uterine fetal death prior to 20 weeks of gestational age; stillbirth, the same, \>= 20 weeks; preterm delivery, \< 37 weeks of gestational age; low birth weight, \< 2,500 grams, and congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria. |
| Secondary | Number of Infants With Grade 3 or Higher Clinical or Laboratory AE | Measured from study entry through Week 48 after birth | Laboratory, sign/symptom, or diagnoses graded as 3 or higher by DAIDS criteria. |
| Secondary | Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment | Measured from study entry through Week 48 after birth | As before, but AE is judged to be possibly, probably, or definitely related to INH or Placebo for INH, by clinic medical staff |
| Secondary | Number of Infants Which Are HIV-infected | Measured from study entry through study Week 44 | HIV infection determined during follow-up period. Infection at birth or during breastfeeding |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment | Measured from study entry through Week 48 after birth | All women enrolled. | events per 100 person-years | NUMBER |
| SECONDARY | Number of Mothers With a Fetal Death | Measured from study entry through end of pregnancy | Mothers who had at least one live birth, stillbirth, or spontaneous abortion. One participant with outcome of induced abortion not included | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Mothers With a Fetus Small for Gestational Age | Measured at delivery | Measurement of small-for-gestational-age was deemed to be unreliable. Analysis not performed. | ||
| SECONDARY | Number of Mothers With an Infant Born Prematurely | Measured at delivery | Mothers who had at least one live birth | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Mothers With a Low Birth-weight Infant | Measured on day of birth | Mothers who had at least one live birth available to be weighed at time of delivery | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Mothers With an Infant With a Congenital Anomaly | Measured from study entry through Week 48 after birth | Mothers who had at least one live birth able to be assessed between birth and 48 weeks after birth | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Mothers With an Adverse Pregnancy Outcome: Spontaneous Abortion, Stillbirth, Premature Birth, Low Birth Weight, or Congenital Anomaly | Measured from study entry through Week 48 after birth | Mothers who had at least one live birth, stillbirth, or spontaneous abortion; participant with induced abortion is omitted, and whose babies were available for examination after birth (if born alive) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infants With Grade 3 or Higher Clinical or Laboratory AE | Measured from study entry through Week 48 after birth | Infants born alive | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment | Measured from study entry through Week 48 after birth | Infants born alive | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infants Which Are HIV-infected | Measured from study entry through study Week 44 | Infants born alive | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment | Arm A (Immediate INH Treatment) | 15.03 | events per 100 person-years | ||
| Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment | Arm B (Deferred INH Treatment) | 14.93 | events per 100 person-years | ||
| Number of Mothers With a Fetal Death | Arm A (Immediate INH Treatment) | 17 | Participants | ||
| Number of Mothers With a Fetal Death | Arm B (Deferred INH Treatment) | 9 | Participants | ||
| Number of Mothers With an Infant Born Prematurely | Arm A (Immediate INH Treatment) | 48 | Participants | ||
| Number of Mothers With an Infant Born Prematurely | Arm B (Deferred INH Treatment) | 40 | Participants | ||
| Number of Mothers With a Low Birth-weight Infant | Arm A (Immediate INH Treatment) | Yes | 62 | Participants | |
| Number of Mothers With a Low Birth-weight Infant | Arm B (Deferred INH Treatment) | Yes | 46 | Participants | |
| Number of Mothers With a Low Birth-weight Infant | Arm A (Immediate INH Treatment) | No | 368 | Participants | |
| Number of Mothers With a Low Birth-weight Infant | Arm B (Deferred INH Treatment) | No | 400 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Immediate INH Treatment) | 477 | |
| Overall Study | STARTED | Arm B (Deferred INH Treatment) | 479 | |
| Overall Study | COMPLETED | Arm A (Immediate INH Treatment) | 389 | |
| Overall Study | COMPLETED | Arm B (Deferred INH Treatment) | 396 | |
| Overall Study | NOT COMPLETED | Arm A (Immediate INH Treatment) | 88 | |
| Overall Study | NOT COMPLETED | Arm B (Deferred INH Treatment) | 83 |
Source ClinicalTrials.gov
Adverse events636
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Congenital umbilical hernia | Congenital, familial and genetic disorders | Mother/Immediate INH | 0 | 477 | |
| other | Congenital umbilical hernia | Congenital, familial and genetic disorders | Mother/Deferred INH | 0 | 479 | |
| other | Congenital umbilical hernia | Congenital, familial and genetic disorders | Infant/Immediate INH | 36 | 445 | |
| other | Congenital umbilical hernia | Congenital, familial and genetic disorders | Infant/Deferred INH | 41 | 464 | |
| other | Abdominal pain | Gastrointestinal disorders | Mother/Immediate INH | 24 | 477 | |
| other | Abdominal pain | Gastrointestinal disorders | Mother/Deferred INH | 15 | 479 | |
| other | Abdominal pain | Gastrointestinal disorders | Infant/Immediate INH | 2 | 445 | |
| other | Abdominal pain | Gastrointestinal disorders | Infant/Deferred INH | 0 | 464 | |
| other | Diarrhoea | Gastrointestinal disorders | Mother/Immediate INH | 37 | 477 | |
| other | Diarrhoea | Gastrointestinal disorders | Mother/Deferred INH | 25 | 479 |
1 to 10 of 636Source ClinicalTrials.gov
See all 636 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mother/Immediate INH | 2 | 477 |
| Total, all-cause mortality | Mother/Deferred INH | 4 | 479 |
| Total, all-cause mortality | Infant/Immediate INH | 11 | 445 |
| Total, all-cause mortality | Infant/Deferred INH | 17 | 464 |
| Total, other adverse events | Mother/Immediate INH | 438 | 477 |
| Total, other adverse events | Mother/Deferred INH | 449 | 479 |
| Total, other adverse events | Infant/Immediate INH | 417 | 445 |
| Total, other adverse events | Infant/Deferred INH | 430 | 464 |
| Total, serious adverse events | Mother/Immediate INH | 71 | 477 |
| Total, serious adverse events | Mother/Deferred INH | 69 | 479 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Immediate INH Treatment) vs Arm B (Deferred INH Treatment): Number of Mothers With an Infant Born Prematurely | Trial comparisons |
| Arm A (Immediate INH Treatment) vs Arm B (Deferred INH Treatment): Number of Infants Hospitalized | Trial comparisons |
| Arm A (Immediate INH Treatment) vs Arm B (Deferred INH Treatment): Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment | Trial comparisons |
| Arm A (Immediate INH Treatment) vs Arm B (Deferred INH Treatment): Number of Infants With Grade 3 or Higher Clinical or Laboratory AE | Trial comparisons |
| Arm A (Immediate INH Treatment) vs Arm B (Deferred INH Treatment): Number of Mothers With a Fetal Death | Trial comparisons |
| Arm A (Immediate INH Treatment) vs Arm B (Deferred INH Treatment): Number of Mothers With Tuberculosis Resistant to INH | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01494038
GET https://conductscience.org/api/trials/v1/NCT01494038/registered?page=2