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Sponsors and Collaborators: |
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 |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00573001 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tenofovir/Emtricitabine and Nevirapine Drug: Tenofovir/Emtricitabine/Efavirenz Drug: Tenofovir and Lopinavir/Ritonavir Drug: Tenofovir/Emtricitabine and Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Tenofovir/Emtricitabine and Nevirapine
Truvada 245/200mg 1cp/day Nevirapine 200mg 2cp/day after first 14 days
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2: Experimental |
Drug: Tenofovir and Lopinavir/Ritonavir
Viread 300mg 1cp/day Aluvia 400/100mg 4cp/day
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3: Experimental |
Drug: Tenofovir/Emtricitabine and Zidovudine
Truvada 245/200mg 1cp/day Zidovudine 300mg 2cp/day
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4: Active Comparator |
Drug: Tenofovir/Emtricitabine/Efavirenz
Atripla 300/200/600mg 1cp/day
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aida Benalycherif | 01.40.25.63.54 | a.bac@bichat.inserm.fr |
Contact: Babacar Sylla | 01.40.25.63.54 | syllababacar2000@yahoo.fr |
Cameroon | |
Hopital Central | Recruiting |
Yaounde, Cameroon | |
Contact: Maguy Ngolle, MD ngollemaguy@yahoo.fr | |
Senegal | |
Hopital de Fann | Recruiting |
Dakar, Senegal | |
Contact: Mouhamadou Baila Diallo, MD mamadoubaila@yahoo.fr | |
Principal Investigator: Papa Salif Sow, MD |
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 |
Responsible Party: | ANRS ( Jean-François Delfraissy ) |
Study ID Numbers: | ANRS12115 DAYANA, IMEA 032 |
Study First Received: | December 12, 2007 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00573001 |
Health Authority: | Cameroon: Ministry of Public Health; Senegal: Ministere de la sante |
naive HIV-1 simplified treatment Treatment Experienced |
Efavirenz Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Immunologic Deficiency Syndromes Virus Diseases Nevirapine Emtricitabine |
Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |