Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA) (DAYANA)
|HIV Infections||Drug: Tenofovir/Emtricitabine (Truvada) and Nevirapine Drug: Tenofovir/Emtricitabine/Efavirenz (Atripla) Drug: Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia) Drug: Tenofovir/Emtricitabine (Truvada) and Zidovudine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Randomized Trial Evaluating the Virological Efficacy and the Tolerance of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Dakar and Yaounde|
- Percentage of patients with viral load below 50 copies/mL [ Time Frame: week 16 ]
- Percentage of patients with viral Load under 50 copies/ml and under 400 copies/ml [ Time Frame: W4, W12, W24, W36, W72, and W96 ]
- Severe adverse event onset, metabolic alterations, lipodystrophia [ Time Frame: J0, W16, W24, W48, W72, W96 ]
- Residual ARV plasmatic concentration [ Time Frame: W4, W48 ]
- CD4 count evolution [ Time Frame: J0, W4, W16, W24, W36, W48, W72, W96 ]
- quality of life parameters, observance [ Time Frame: J0, W4, W8, W12, W16, W24, W36, W48, W72, W96 ]
|Study Start Date:||July 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Drug: Tenofovir/Emtricitabine (Truvada) and Nevirapine
Tenofovir/Emtricitabine(Truvada) 245/200mg 1cp/day ; Nevirapine 200mg 2cp/day after first 14 days
Other Name: Truvada
Drug: Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)
Tenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day
Drug: Tenofovir/Emtricitabine (Truvada) and Zidovudine
Tenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day
Other Name: Truvada
|Active Comparator: 4||
Drug: Tenofovir/Emtricitabine/Efavirenz (Atripla)
Tenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day
Other Name: Atripla
The efficacy of antiretroviral treatments in sub-Saharan Africa has been demonstrated in cohort studies and pilot trials. The treatment regimens tested in these studies were derived from those used in pre-marketing trials conducted in industrialized countries.
However, the choice of antiretrovirals for national programs in poor countries is largely based on drug availability through the Access program, together with cost and supply considerations, rather than on field evaluations of recommended strategies.
Concomitantly with the development of antiretroviral access programs in the southern hemisphere, first-line treatments in industrialized countries have tended to become simpler, thereby improving their convenience and reducing the incidence and severity of their adverse effects. These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir. These simplified strategies are being extensively evaluated in industrialized countries.
Long-term economic benefits will be a determining factor in the adoption of these strategies by poor countries.
We will conduct a phase-III unblinded randomised trial focusing on the early virologic efficacy, tolerability and immuno-virologic efficacy of four simplified antiretroviral regimens given for 96 weeks to previously untreated HIV-1-infected patients in Senegal and Cameroon. The following four simplified treatments will be tested: TDF/FTC/NVP, LPV/TDF, TDF/FTC/AZT and TDF/FTC/EFV. The required number of patients (n=120) is compatible with the short-term recruitment capacity of two clinical investigation centers in Senegal and Cameroon.
The goal of this trial is to demonstrate that these new treatments are as effective as a reference triple-agent regimen (TDF/FTC/EFV) in driving plasma viral load below the detection limit early during treatment. The principal objective is to identify simplified treatments capable of driving viral load below 50 copies/mL at week 16 in at least 50% of patients. If successful, the initial treatments will be continued and re-assessed at 96 weeks.
120 patients previously unexposed to antiretroviral drugs will be recruited over a one-year period in two treatment centers in Dakar (Infectious Diseases department of Fann University Hospital) and Cameroon (Yaounde Military Hospital and Principal Hospital)
This study is fully in keeping with WHO/UNAIDS recommendations on antiretroviral treatment simplification in poor countries. These new treatments must be evaluated in the countries concerned, given the often very advanced stage of HIV disease at diagnosis, intercurrent health disorders, and local socioeconomic conditions.
This trial is not designed to compare these new treatments with one another, but rather to select the most promising treatments for future use. These preliminary results will help with the choice of treatment strategies for cohort studies and large-scale randomized trials.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573001
|Hopital de Fann|
|Principal Investigator:||Landman Roland, MD||Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba|
|Principal Investigator:||Sow Papa Salif, MD||Hopital de Fann, Dakar|
|Principal Investigator:||Koulla Shiro Sinata, MD||Hopital Central Yaoundé|