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NCT00000636 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
NA
Development phase
2,000
Enrollment target

NCT00000636: Completed NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000636 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2,000 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000636, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
2,000 participants
Enrollment target

Study Summary

To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). 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.

Interventions

  • DRUG Rifampin
  • DRUG Pyrazinamide
  • DRUG Isoniazid
  • DRUG Pyridoxine hydrochloride

Trial Details

FieldValue
Enrollment Target 2,000 participants
Est. Completion 1997-10
Phase NA

What the finished NCT00000636 record still lists

NCT00000636 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% higher).

The record links to 0 conditions, and to 4 interventions - of which Rifampin is the first listed.

NCT00000636 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000636 about?

NCT00000636 is a clinical study titled "Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection". To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 ...

What is the current status of trial NCT00000636?

This trial is currently completed. It is a NA study. The enrollment target is 2,000 participants. Estimated completion is 1997-10.

What interventions are being tested in trial NCT00000636?

The interventions under investigation include: Rifampin (DRUG), Pyrazinamide (DRUG), Isoniazid (DRUG), Pyridoxine hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00000636?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00000636's enrollment target sits among peer trials

2,000 52nd of 2000 higher than 1,947 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00000636, the US trial registry maintained by the National Library of Medicine. NCT00000636 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.