deltatrials
Completed NA INTERVENTIONAL NCT00000636

Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Updated 8 times since 2017 Last updated: Oct 26, 2021 Completion: Oct 31, 1997
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates HIV Infections and Tuberculosis and is currently completed. National Institute of Allergy and Infectious Diseases (NIAID) leads this study, which shows 8 recorded versions since 2026 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Study Description(click to expand)

Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance. After baseline screening, patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months, then every three months for the first year (there are additional clinic visits for INH patients). Patients are then evaluated every six months. One group of patients takes INH plus vitamin B6 for 12 months. The other group of patients takes 1 of 2 doses of rifampin (depending on patient's weight) plus pyrazinamide in 3-4 divided doses for 60 days.

Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.

After baseline screening, patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months, then every three months for the first year (there are additional clinic visits for INH patients). Patients are then evaluated every six months. One group of patients takes INH plus vitamin B6 for 12 months. The other group of patients takes 1 of 2 doses of rifampin (depending on patient's weight) plus pyrazinamide in 3-4 divided doses for 60 days.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2025 — Present [monthly]

    Completed NA

  3. Sep 2024 — Sep 2025 [monthly]

    Completed NA

  4. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  5. Dec 2021 — Jul 2024 [monthly]

    Completed NA

Show 3 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Completed NA

  2. Jun 2018 — Jan 2021 [monthly]

    Completed NA

  3. Jan 2017 — Jun 2018 [monthly]

    Completed NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .