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

Study Overview
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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.

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

Conditions
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HIV Infections, Tuberculosis

Intervention / Treatment
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* Drug: Early versus intermediate versus late initiation of ART


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 - Early integrated-therapy group<br>antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment | Drug: Early versus intermediate versus late initiation of ART<br>* 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<br>|
| Active Comparator: 2 - Late integrated-therapy group<br>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<br>* 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<br>|
| Active Comparator: 3 - Sequential-therapy group<br>Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment | Drug: Early versus intermediate versus late initiation of ART<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the incidence of progression to AIDS defining illness or mortality |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, antiretroviral therapy, Opportunistic infections, CD4, Viral load, TB/HIV co infection, Treatment Naive