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Longer TB prevention pill cuts risk in HIV patients

NCT ID NCT00164281

Prevention Sponsor: Centers for Disease Control and Prevention Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether taking the tuberculosis prevention drug isoniazid for 36 months instead of the usual 6 months could better prevent TB in adults with HIV. Nearly 2,000 participants in Botswana were randomly assigned to either short or long treatment. The goal was to see if longer therapy reduces new TB cases and deaths.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isoniazid
What this could lead to
If successful, this could show that extending isoniazid preventive therapy beyond 6 months reduces tuberculosis cases in people with HIV.
What could go wrong
This is a completed Phase 4 trial, so results are already known. However, the benefit may not apply to all populations or settings, and isoniazid can cause liver side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,995 people

The number who actually took part.

Start date

Nov 2004

Finished

May 2011

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. HIV-infected 2. Age \>=18 years 3. Tuberculin skin test positive or negative 4. Laboratory: * Hemoglobin (Hgb) \>6.5 gm/dl; * Neutrophil count \>1,000 cells/mm3; * Platelets \>75,000/mm3; * AST (SGOT) \<122 U/L; * Creatinine \<1.5 mg/dl; * Beta HCG = negative 5. Karnofsky performance status \>=60 6. Signed informed consent Exclusion Criteria: 1. History of TB in the last 3 years or current active TB 2. History of noncompliance to chronic therapies

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease tuberculosis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections Tuberculosis

Contacts and locations

Locations

  • Gaborone and Francistown Health Clinics

    Gaborone, Botswana

More trials for these conditions

Other studies related to the condition(s) this trial covers.