In the well recognized context of HIV infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen. This multicentre international, randomized, non-blinded phase III trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line HIV-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/mL versus \> 5000 copies/mL) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Evaluation of second line antiretroviral regimen including boosted lopinavir
Evaluation of second line antiretroviral regimen including boosted atazanavir
Tshepang clinic, Limpopo University
Pretoria, South Africa
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital
Mbeya, Tanzania
Virological response
Proportion of patients with plasma HIV RNA \< 50 copies/mL
Time frame: 48 weeks
Virological response
Proportion of patients with plasma HIV RNA \< 400 copies/mL
Time frame: 12 and 24 weeks
Viral resistance
Incidence of resistance mutations after treatment failure (HIV RNA \< 1000 copies/mL)
Time frame: 12, 24 and 48 weeks
Clinical course of HIV infection
Mortality, occurence of clinical events stage 3 or 4 (WHO classification), immune reconstitution sundrome, non-AIDS clinical events including bacterial infections
Time frame: Up to 48 weeks
Tolerance assessment
Proportion of adverse events related to antiretroviral treatment, proportion of treatement discontinuations due to antiretroviral side effect, variation of biological parameters and metabolic markers between second line antiretroviral initiation and 24/48 weeks.
Time frame: 24 and 48 weeks
Adherence assessment
Measurement of pills consumption at each visit, face-to-face questionnaire with the pharmacist
Time frame: At each protocol visit : week 2, 4, 12, 24, 36 and 48
Hepatitis B evaluation
Prevalence of HBs AG, HBe Ag, HBV viremia, and HBV asociated drug resistance mutations at baseline
Time frame: At entry
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Immunologic response
Variation of circulating total and CD4+ lymphocyte count between second line treatment initiation and 24 weeks/48 weeks
Time frame: 24 and 48 weeks