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Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)

This study has been completed.
Sponsor:
Collaborators:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Gilead Sciences
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT00573001
First received: December 12, 2007
Last updated: May 14, 2012
Last verified: May 2012

December 12, 2007
May 14, 2012
July 2008
July 2011   (final data collection date for primary outcome measure)
Percentage of patients with viral load below 50 copies/mL [ Time Frame: week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00573001 on ClinicalTrials.gov Archive Site
  • Percentage of patients with viral Load under 50 copies/ml and under 400 copies/ml [ Time Frame: W4, W12, W24, W36, W72, and W96 ] [ Designated as safety issue: No ]
  • Severe adverse event onset, metabolic alterations, lipodystrophia [ Time Frame: J0, W16, W24, W48, W72, W96 ] [ Designated as safety issue: Yes ]
  • Residual ARV plasmatic concentration [ Time Frame: W4, W48 ] [ Designated as safety issue: No ]
  • CD4 count evolution [ Time Frame: J0, W4, W16, W24, W36, W48, W72, W96 ] [ Designated as safety issue: No ]
  • quality of life parameters, observance [ Time Frame: J0, W4, W8, W12, W16, W24, W36, W48, W72, W96 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)
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

The goal of this trial is to demonstrate that new treatments are as effective as a reference triple-agent regimen in driving plasma viral load below the detection limit early during treatment (16 weeks). These simplified treatments involve fewer tablets and intakes, fixed-dose combinations, and also radically new strategies such as boosted protease inhibitor and tenofovir.

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.

Methods:

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.

Objective:

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.

Study design:

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)

Expected results:

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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/Emtricitabine/Efavirenz (Atripla)
    Tenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day
    Other Name: Atripla
  • Drug: Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)
    Tenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day
    Other Names:
    • Viread
    • Aluvia
  • Drug: Tenofovir/Emtricitabine (Truvada) and Zidovudine
    Tenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day
    Other Name: Truvada
  • Experimental: 1
    Intervention: Drug: Tenofovir/Emtricitabine (Truvada) and Nevirapine
  • Experimental: 2
    Intervention: Drug: Tenofovir (Viread) and Lopinavir/Ritonavir (Aluvia)
  • Experimental: 3
    Intervention: Drug: Tenofovir/Emtricitabine (Truvada) and Zidovudine
  • Active Comparator: 4
    Intervention: Drug: Tenofovir/Emtricitabine/Efavirenz (Atripla)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age over 18 years for Senegal and over 21 years for Cameroon
  • HIV-1 infected patient
  • patient naive from any antiretroviral treatment
  • CD4 cell count over 50 cells per mm3
  • contraceptive method use
  • informed consent signed

Exclusion Criteria:

  • opportunistic infection ongoing or any other serious pathology
  • ongoing treatment with rifampicine
  • severe renal or hepatic impairment
  • HbSAg positive
  • Hemoglobine under 8g/L
  • Neutrophils under 500 cells per mm3
  • ongoing pregnancy or breastfeeding
  • treatment by contra-indicated drugs (as described in study drugs notices)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Cameroon,   Senegal
 
NCT00573001
ANRS12115 DAYANA, IMEA 032
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
French National Agency for Research on AIDS and Viral Hepatitis
  • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
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
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP