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

Condition(s) targeted: HIV Infection

Intervention: Tenofovir (TDF) (Drug); Emtricitabine (FTC) (Drug); Efavirenz (EFV) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis

Official(s) and/or principal investigator(s):
Roland Landman, Study Chair, Affiliation: IMEA- Hôpital Bichat Claude Bernard, France
Papa Salif Sow, Principal Investigator, Affiliation: CHU de Fann, Dakar

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.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml

Viral load evolution

Genotype resistance profile evaluation failing patients

Immune benefits of the combination

Plasma concentrations of FTC, TDF and EFV

Adverse events clinic and lipids

Compliance

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Service des Maladies Infectieuses, CHU de Fann, Dakar, Senegal

Centre de Traitement Ambulatoire, CHU de Fann, Dakar, Senegal

Starting date: June 2004
Ending date: December 2006
Last updated: July 2, 2007