HIV Infections, Tuberculosis
Conditions
Keywords
antiretroviral therapy, HIV, Opportunistic infections, CD4, Viral load, TB/HIV co infection, Treatment Naive
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.
Interventions
DRUGEarly 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
Sponsors
Centre for the AIDS Programme of Research in South Africa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the incidence of progression to AIDS defining illness or mortality | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms | 18 months |
Countries
South Africa
Outcome results
None listed