A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

642 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-07-31

Brief Summary

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This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients:

Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment

Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.

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Detailed Description

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Conditions

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HIV Infections Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 - Early integrated-therapy group

antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment

Group Type ACTIVE_COMPARATOR

Early versus intermediate versus late initiation of ART

Intervention Type DRUG

Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed

2 - Late integrated-therapy group

antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment

Group Type ACTIVE_COMPARATOR

Early versus intermediate versus late initiation of ART

Intervention Type DRUG

Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed

3 - Sequential-therapy group

Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment

Group Type ACTIVE_COMPARATOR

Early versus intermediate versus late initiation of ART

Intervention Type DRUG

Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed

Interventions

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Early versus intermediate versus late initiation of ART

Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV infected patients co-infected with TB
* Receiving any one of the standard anti-TB therapy regimens
* All patients must agree to use contraception since they will be on efavirenz.

Exclusion Criteria

* Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No