HIV Infections Clinical Trial
Official title:
Multicentric, Non-inferiority, Randomized, Non-blinded Phase 3 Trial Comparing Virological Response at 48 Weeks of 3 Antiretroviral Treatment Regimens in HIV-1-infected Patients With Treatment Failure After 1st Line Antiretroviral Therapy (Cameroon, Burkina Faso, Senegal)
Since the first line antiretroviral (ARV) treatment is now largely accessible in the
Sub-Saharian Africa countries, documentation of virological failure, drug resistance
patterns and second line treatment evaluation are still to be consolidated in settings where
viral load monitoring is not available and non-B HIV subtype is predominant.
This trial aims at evaluating the efficacy and tolerance of 3 different second line
treatment strategies: two recommended by WHO combine two non-nucleoside reverse
transcriptase inhibitor associated with a ritonavir boosted protease inhibitor
(emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir);
the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet
evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a
better tolerance and its single daily administration may facilitate treatment adherence.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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