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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158457
• Other study ID #: ANRS 1207
• Secondary ID: IMEA 025
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: July 2, 2007
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2007
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Tenofovir (TDF)

• Emtricitabine (FTC)

• Efavirenz (EFV)

Locations

Country	Name	City	State
Senegal	Centre de Traitement Ambulatoire, CHU de Fann	Dakar
Senegal	Service des Maladies Infectieuses, CHU de Fann	Dakar

Sponsors (3)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Gilead Sciences, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Country where clinical trial is conducted

Senegal, 

Outcome

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