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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
454
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
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
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
Day Hospital, CHU Sanou Souro
Bobo-Dioulasso, Burkina Faso
Day Hospital, Central Hospital
Yaoundé, Cameroon
Clinical Research and Training Center, Fann Hospital
Dakar, Senegal
Number of Patients With Plasma HIV RNA < 50 Copies/mL
Time frame: 48 weeks
Number of Patients With WHO Stage 3 and 4 HIV Related Events
patients having a diagnosis of HIV related event classified as stage 3 or 4
Time frame: between baseline and 48 weeks
Patients With Plasma HIV RNA < 200 Copies/ml
number of patients with plasma HIV RNA below 200 copies/ml
Time frame: 48 weeks
Gain in CD4 Cells Between Baseline and W48
median gain in circulating CD4 cells between baseline and W48
Time frame: between baseline and 48 weeks
Number of Patients Discontinuing Study Treatment
number of patients discounting treatment because of adverse events
Time frame: between baseline and W48
Tolerance: Gastrointestinal Complains
Gastrointestinal complaints (grade 1 to 4) between baseline and W48.
Time frame: between baseline and 48 weeks
Tolerance: Neuropathies (Grade 1 to 4)
any symptom of peripheral neuropathy
Time frame: between baseline and W48
Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value
Time frame: between baseline and W48
Adherence
number of patients in different categories of adherence as measured by questionnaire
Time frame: between baseline and W48
Number of Patients With Resistance Mutations
number of patients with resistance mutations after second line treatment failure (HIV RNA\> 1000 copies/ml)
Time frame: between W12 and W48
Development of Metabolic Syndrome
number of patients developing metabolic syndrome over a period of 48 weeks
Time frame: from baseline to week 48
Number of Patients With HIV Plasma Viral Load < 50 Copies/ml
Snapshot of patients with HIV viral load less then 50 copies/ml at week 24
Time frame: Week 24
Number of Patients With HIV Plasma Viral Load < 200 Copies/ml
number of patients having a plasma viral load below 200 copies/ml at week 24
Time frame: Week 24
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