- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573001
Evaluation of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Africa (ANRS 12115 DAYANA) (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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Tenofovir/Emtricitabine(Truvada) 245/200mg 1cp/day ; Nevirapine 200mg 2cp/day after first 14 days
Other Names:
|
Experimental: 2
|
Tenofovir (Viread) 300mg 1cp/day ; Lopinavir/Ritonavir (Aluvia) 400/100mg 4cp/day
Other Names:
|
Experimental: 3
|
Tenofovir/Emtricitabine (Truvada) 245/200mg 1cp/day ; Zidovudine 300mg 2cp/day
Other Names:
|
Active Comparator: 4
|
Tenofovir/Emtricitabine/Efavirenz (Atripla) 300/200/600mg 1cp/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with viral load below 50 copies/mL
Time Frame: week 16
|
week 16
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with viral Load under 50 copies/ml and under 400 copies/ml
Time Frame: W4, W12, W24, W36, W72, and W96
|
W4, W12, W24, W36, W72, and W96
|
Severe adverse event onset, metabolic alterations, lipodystrophia
Time Frame: J0, W16, W24, W48, W72, W96
|
J0, W16, W24, W48, W72, W96
|
Residual ARV plasmatic concentration
Time Frame: W4, W48
|
W4, W48
|
CD4 count evolution
Time Frame: J0, W4, W16, W24, W36, W48, W72, W96
|
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
|
J0, W4, W8, W12, W16, W24, W36, W48, W72, W96
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Tenofovir
- Emtricitabine
- Nevirapine
- Ritonavir
- Lopinavir
- Zidovudine
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
- Efavirenz
- Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Other Study ID Numbers
- ANRS12115 DAYANA
- IMEA 032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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