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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead 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
• Treatments: Efavirenz; Emtricitabine; Tenofovir

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