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

NCT ID: NCT00158457

Last Updated: 2007-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-12-31

Brief 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.

Conditions

HIV Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Tenofovir (TDF)

Intervention Type: DRUG

Emtricitabine (FTC)

Intervention Type: DRUG

Efavirenz (EFV)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

OTHER

Sponsor Role: collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Roland Landman

Role: STUDY_CHAIR

IMEA- Hôpital Bichat Claude Bernard, France

Papa Salif Sow

Role: PRINCIPAL_INVESTIGATOR

CHU de Fann, Dakar

Locations

Centre de Traitement Ambulatoire, CHU de Fann

Dakar, , Senegal

Service des Maladies Infectieuses, CHU de Fann

Dakar, , Senegal

Countries

Senegal

Other Identifiers

IMEA 025

Identifier Type: -

Identifier Source: secondary_id

ANRS 1207

Identifier Type: -

Identifier Source: org_study_id