Trial · NCT00080119
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
NCT00080119, Phase 2, Phase 3, Terminated, International Maternal Pediatric Adolescent AIDS Clinical Trials Group; results first posted 2010-10-19
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ConductScience Library. Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV. Trials, record NCT00080119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00080119
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
- NCT number
- NCT00080119
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,354 participants, actual
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Interventions
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX), Isoniazid Placebo (PL)
- First posted
- 2004-03-25
- Last updated
- 2019-02-05
- Results first posted
- 2010-10-19
- Limitations and caveats
DSMB recommended stopping study due to futility: no compelling reason to enroll additional infants or to continue to treat participants with the blinded study medication. Week 192 analyses not done as \<4% (26%) of HIVpos (HIVneg) reached wk 192
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children | Through to week 96 | Criteria for diagnosis with TB disease: Definite-isolation of Mycobacterium TB (M.tb) or +ve stain on cerebrospinal fluid (CSF); Probable- +ve acid fast bacilli (AFB) stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of pulmonary TB (PTB) and either a +ve tuberculin skin test (TST) or minimum score on algorithm for clinical TB. Records reviewed by Endpoint Review Group. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method. |
| Primary | Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive tuberculin skin test (TST) based on a purified protein derivative (PPD) performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to Development of TB Infection or Death Among HIV-infected Children | Through to week 96 | Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children | Through to week 96 | HIV disease progression was defined as any advancement in Centers for Disease Control (CDC) disease category from entry or death. If a participant was CDC disease category C at entry progression was defined as death. Results report percent of participants with HIV progression or death by week 96 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to Development of TB Disease Among HIV Infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to Development of TB Infection Among HIV-infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection by week 96 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to Death Among HIV-infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Deaths from any cause were included. Results report percent of participants dying by week 96 calculated using the Kaplan-Meier method. |
| Secondary | Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Any event of grade 3 or higher not present at entry that occurred after randomization was classified as a new event. Results report percent of participants with a new event by week 96 calculated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children | Through to week 96 | Includes HIVpos who started study treatment. Time from randomization to TB disease/death was calculated. Participants lost-to-follow-up (LTF) \<96 wks (+12wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. Participants on study when study discontinued censored at discontinuation visit. | Percent of participants | NUMBER |
| PRIMARY | Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children | Through to week 96 | HIVneg who started study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants lost-to-follow-up before 96 wks were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks (+12 week window) who were free of TB infection were censored at 96 weeks (+12 week window). | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to Development of TB Infection or Death Among HIV-infected Children | Through to week 96 | HIVpos starting study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants LTF \<96 weeks (+12 wk) censored at the time LTF. Participants in follow-up at 96 wks free of TB infection censored at 96 wks. Participants on study when study discontinued were censored at discontinuation visit. | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children | Through to week 96 | Includes HIVpos starting study treatment. Time from randomization to first of disease progression/death calculated. Censored if LTF \<96 wks, at 96 wks (if on study) or at discontinuation visit. Participants found to be HIVneg upon repeat testing could only progress by meeting a death endpoint. | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Includes HIVneg who started study treatment. Time from randomization to the first of TB disease/death was calculated. Participants lost-to-follow-up before 96 weeks (+12 week window)were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks who were free of TB disease were censored at 96 weeks (+12 week window). | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to Development of TB Disease Among HIV Infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Includes all starting study treatment. Time from randomization to development of TB disease was calculated. Participants LTF \<96 wks (+12 wks) censored at time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. HIVpos on study when study discontinued were censored at their discontinuation visit. | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to Development of TB Infection Among HIV-infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Includes all starting study treatment. Time from randomization to development of TB infection was calculated. Participants LTF \<96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB infection were censored at 96 wks. HIVpos on study when study discontinued censored at their discontinuation visit. | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to Death Among HIV-infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Includes all starting study treatment. Time from randomization to death was calculated. Participants LTF \<96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks (+12 wks) censored at 96 weeks. HIVpos on study when study was discontinued were censored at their discontinuation visit. | Percent of participants | NUMBER |
| SECONDARY | Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children | Through to week 96 | Includes all starting treatment. Time from randomization to first new adverse event (AE) calculated. For lab toxicities, censored at visit following permanent discontinuation of study drugs. For signs/symptoms, participants in follow-up at 96 wks (+12) with no new grade \>=3 AE censored at 96 wks. Participants LTF \<96 wks censored at LTF. | Percent of participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children | HIVpos/INH | 27.4 | Percent of participants | ||
| Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children | HIVpos/PL | 28.9 | Percent of participants | ||
| Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children | HIVneg/INH | 10.9 | Percent of participants | ||
| Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children | HIVneg/PL | 12.6 | Percent of participants | ||
| Time From Randomization to Development of TB Infection or Death Among HIV-infected Children | HIVpos/INH | 29.4 | Percent of participants | ||
| Time From Randomization to Development of TB Infection or Death Among HIV-infected Children | HIVpos/PL | 32.8 | Percent of participants | ||
| Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children | HIVpos/INH | 30.6 | Percent of participants | ||
| Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children | HIVpos/PL | 22.5 | Percent of participants | ||
| Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children | HIVneg/INH | 8.3 | Percent of participants | ||
| Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children | HIVneg/PL | 9.1 | Percent of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HIVneg/INH | 403 | |
| Overall Study | STARTED | HIVneg/PL | 401 | |
| Overall Study | STARTED | HIVpos/INH | 273 | |
| Overall Study | STARTED | HIVpos/PL | 274 | |
| Overall Study | COMPLETED | HIVneg/INH | 347 | |
| Overall Study | COMPLETED | HIVneg/PL | 339 | |
| Overall Study | COMPLETED | HIVpos/INH | 108 | |
| Overall Study | COMPLETED | HIVpos/PL | 111 | |
| Overall Study | NOT COMPLETED | HIVneg/INH | 56 | |
| Overall Study | NOT COMPLETED | HIVneg/PL | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events252
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 | Lymphadenitis | Blood and lymphatic system disorders | HIVneg/INH | 0 | 403 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | HIVneg/PL | 1 | 401 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | HIVpos/INH | 10 | 273 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | HIVpos/PL | 28 | 274 | |
| other | Diarrhoea | Gastrointestinal disorders | HIVneg/INH | 16 | 403 | |
| other | Diarrhoea | Gastrointestinal disorders | HIVneg/PL | 28 | 401 | |
| other | Diarrhoea | Gastrointestinal disorders | HIVpos/INH | 18 | 273 | |
| other | Diarrhoea | Gastrointestinal disorders | HIVpos/PL | 26 | 274 | |
| other | AIDS encephalopathy | Infections and infestations | HIVneg/INH | 0 | 403 | |
| other | AIDS encephalopathy | Infections and infestations | HIVneg/PL | 1 | 401 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HIVneg/INH | ||
| Total, all-cause mortality | HIVneg/PL | ||
| Total, all-cause mortality | HIVpos/INH | ||
| Total, all-cause mortality | HIVpos/PL | ||
| Total, other adverse events | HIVneg/INH | 353 | 403 |
| Total, other adverse events | HIVneg/PL | 368 | 401 |
| Total, other adverse events | HIVpos/INH | 264 | 273 |
| Total, other adverse events | HIVpos/PL | 268 | 274 |
| Total, serious adverse events | HIVneg/INH | 25 | 403 |
| Total, serious adverse events | HIVneg/PL | 18 | 401 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI068632 | International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group | JACKSON, J BROOKS | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00080119
GET https://conductscience.org/api/trials/v1/NCT00080119/results?page=2