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NCT00108862 · ClinicalTrials.gov registry record · Phase 4

Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis

A Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

Completed
Registry status
Phase 4
Development phase
809
Enrollment target

NCT00108862: Completed Phase 4 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

NCT00108862 is a Phase 4 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 809 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00108862, a Phase 4 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

COMPLETED
Registry status
Phase 4
Development phase
809 participants
Enrollment target

Study Summary

The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB). Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2 weeks of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death in HIV-infected participants being treated for TB by at least 40% at week 48 when compared to deferred ART, initiated at after 8-12 weeks of TB treatment.

Primary Outcome

As this was a study of the strategy of providing antiretroviral therapy (ART) during the initial treatment of TB versus deferring ART until TB was treated for 8-12 weeks, all eligible participants randomized were followed for 48 weeks, whether they started ART as scheduled, whether they started ART at all, or even if the participant did not have TB and discontinued TB treatment. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associ

Interventions

  • OTHER Strategy: Immediate ART
  • OTHER Strategy: Deferred ART

Trial Details

FieldValue
Enrollment Target 809 participants
Start Date 2006-08
Est. Completion 2010-07
Phase Phase 4

What the finished NCT00108862 record still lists

NCT00108862 is an interventional study that assigns participants to a tested intervention. The registered 809 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% higher).

The record links to 0 conditions, and to 2 interventions - of which Strategy: Immediate ART is the first listed.

NCT00108862 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00108862 about?

NCT00108862 is a clinical study titled "Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis". The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB). Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2 weeks of TB treatment, will reduce the frequency of other AIDS-defining il...

What is the current status of trial NCT00108862?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 809 participants. The study started on 2006-08. Estimated completion is 2010-07.

What interventions are being tested in trial NCT00108862?

The interventions under investigation include: Strategy: Immediate ART (OTHER), Strategy: Deferred ART (OTHER).

Who is sponsoring clinical trial NCT00108862?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00108862's enrollment target sits among peer trials

809 95th of 2000 higher than 1,906 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00108862, the US trial registry maintained by the National Library of Medicine. NCT00108862 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.