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

Centre for the AIDS Programme of Research in South Africa

Status and phase: Completed; Phase 3

Conditions: Tuberculosis; HIV Infections

Treatments: Drug: Early versus intermediate versus late initiation of ART

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00398996

CAPRISA 003

Details and patient eligibility

About

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.

Enrollment: 642 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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642 participants in 3 patient groups

1 - Early integrated-therapy group

Active Comparator group

Description:

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

Treatment:

Drug: Early versus intermediate versus late initiation of ART

2 - Late integrated-therapy group

Active Comparator group

Description:

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

Treatment:

Drug: Early versus intermediate versus late initiation of ART

3 - Sequential-therapy group

Active Comparator group

Description:

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

Treatment:

Drug: Early versus intermediate versus late initiation of ART