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

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ClinicalTrials.gov Identifier: NCT00573001
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : May 15, 2012
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 )

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 13, 2007
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2007)
Percentage of patients with viral load below 50 copies/mL [ Time Frame: week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00573001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2007)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cameroon,   Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00573001
Other Study ID Numbers  ICMJE ANRS12115 DAYANA
IMEA 032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 )
Study Sponsor  ICMJE French National Agency for Research on AIDS and Viral Hepatitis
Collaborators  ICMJE
  • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
Investigators  ICMJE
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
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date May 2012

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