Conditions: HIV HIV Infections
Keywords: HIV Second line treatment WHO recommendations Africa Treatment strategies treatment experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 454
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) arm 2: abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) arm 3: emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)

Interventions: intervention 1: emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) intervention 2: abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) intervention 3: emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)
Intervention descriptions: intervention 1: Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening intervention 2: Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening intervention 3: Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food

Protocol document: