Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)

Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal

In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. This combination has already been studied in the North countries.

Here in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Efavirenz (EFV); Drug: Tenofovir (TDF); Drug: Emtricitabine (FTC)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Senegal
  • Dakar, Senegal
    • Centre de Traitement Ambulatoire, CHU de Fann
  • Dakar, Senegal
    • Service des Maladies Infectieuses, CHU de Fann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented infection with HIV-1 (ELISA- Western Blot)
• Outpatient of masculine or feminine gender
• In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device
• No previous treatment with antiretroviral therapy
• CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.
• Patient has provided informed written consent
• Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator

Exclusion Criteria:

• Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible
• Patient participating in a different clinical study
• Presence of serious or developing pathology
• Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)
• Thrombocytopenia with platelet level under 50 000 cells /ml
• Known severe renal pathology (creatinine clearance under 50 ml/min)
• Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification
• Karnofsky under 70 percent
• Opportunistic infections
• Patients taking medications not recommended in the context of the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population	S48

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml	S24 and S96
Viral load evolution	S24 and S48
Genotype resistance profile evaluation failing patients	S24, S48, S96
Immune benefits of the combination
Plasma concentrations of FTC, TDF and EFV	S4
Adverse events clinic and lipids
Compliance	S48 and S96

Collaborators and Investigators

• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Gilead Sciences; Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Investigators: Study Chair: Roland Landman, IMEA- Hôpital Bichat Claude Bernard, France; Principal Investigator: Papa Salif Sow, CHU de Fann, Dakar

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): July 3, 2007
• Last Update Submitted That Met QC Criteria: July 2, 2007
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: Treatment Naive; HIV infection; Naive patients; Simplification regimen; Once a day; Sub-saharian Africa
• 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; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Tenofovir; Emtricitabine; Efavirenz
• Other Study ID Numbers: ANRS 1207; IMEA 025