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

Sponsor

Centre for the AIDS Programme of Research in South Africa (Other)

Overall Status

Completed

CT.gov ID

NCT00398996

Collaborator

(none)

642

Enrollment

Location

Arms

Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Tuberculosis	Drug: Early versus intermediate versus late initiation of ART	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

642 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 - Early integrated-therapy group antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment	Drug: 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
Active Comparator: 2 - Late integrated-therapy group antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment	Drug: 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
Active Comparator: 3 - Sequential-therapy group Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment	Drug: 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

Arm

Intervention/Treatment

Active Comparator: 1 - Early integrated-therapy group

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

Drug: 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

Active Comparator: 2 - Late integrated-therapy group

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

Drug: 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

Active Comparator: 3 - Sequential-therapy group

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

Drug: 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

Outcome Measures

Primary Outcome Measures

To measure the incidence of progression to AIDS defining illness or mortality [18 months]

Secondary Outcome Measures

A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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