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

Phase 3

Completed

• Conditions: HIV Infections; Tuberculosis
• Interventions: Drug: Early versus intermediate versus late initiation of ART

• Registration Number: NCT00398996
• Lead Sponsor: Centre for the AIDS Programme of Research in South Africa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-23
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 - Early integrated-therapy group	Early versus intermediate versus late initiation of ART	antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment
2 - Late integrated-therapy group	Early versus intermediate versus late initiation of ART	antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment
3 - Sequential-therapy group	Early versus intermediate versus late initiation of ART	Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment

Primary Outcome Measures

Name	Time	Method
To measure the incidence of progression to AIDS defining illness or mortality	18 months

Secondary Outcome Measures

Name	Time	Method
A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms	18 months

Trial Locations

Locations (1)

CAPRISA eThekwini Clinical Research Site; 🇿🇦 Durban, KwaZulu-Natal, South Africa