Clinical trial
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
NCT00080119 · International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Other · Terminated
Key facts
| NCT number | NCT00080119 |
|---|---|
| Title | Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV |
| Official title | A Randomized, Double Blind, Placebo Controlled Trial to Determine the Efficacy of Isoniazid (INH) in Preventing Tuberculosis Disease and Latent Tuberculosis Infection Among Infants With Perinatal Exposure to HIV |
| Lead sponsor | International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Other |
| Collaborators | National Institute of Allergy and Infectious Diseases (NIAID) NIH Comprehensive International Program of Research on AIDS Secure the Future Foundation |
| Status | Terminated |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia |
| Intervention type | Drug |
| Interventions | Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX), Isoniazid Placebo (PL) |
| Enrollment | 1,354 |
| Start date | Feb 1, 2004 |
| Primary completion | May 1, 2009 |
| Completion | May 1, 2009 |
| First posted | Mar 25, 2004 |
| Last update posted | Feb 5, 2019 |
| Countries | Botswana, South Africa |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: