HIV/AIDS Infections and Infestations
Conditions
Interventions
Comparison of two strategies for second-line antiretroviral therapy after 24 weeks of combination Aluvia® (or Kaletra®)-containing antiretroviral therapy:
Arm 1: Continued combination Aluvia-containi
Sponsors
Medical Research Council Clinical Trials Unit (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Enrolled in the DART trial (ISRCTN13968779 at http://www.controlled-trials.com/ISRCTN13968779) 2. Failed first-line antiretroviral therapy (clinically/immunologically) and having completed 24 weeks of second-line combination antiretroviral therapy including ritonavir-boosted lopinavir (as either Aluvia® heat-stable tablets or Kaletra® capsules) 3. Documented informed consent 4. Life expectancy of at least 3 months
Exclusion criteria
Exclusion criteria: Pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in CD4 count at 24 weeks after randomisation (efficacy) 2. Any Serious Adverse Event (SAE), which is not HIV related only (safety) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression to a new or recurrent WHO stage 4 HIV event or death 2. Progression to a new or recurrent WHO stage 3 or 4 HIV event or death 3. Change in CD4 count from SARA randomisation to 48, 72 and 96 weeks 4. Any grade 3 or 4 adverse events 5. HIV RNA viral load (performed retrospectively) at 12, 24, 36, 48, 72 and 96 weeks 6. Adherence as measured by questionnaire and pill counts 7. Health economic outcomes | — |
Countries
Uganda, Zimbabwe
Outcome results
None listed