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

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis (Other)

Overall Status

Completed

CT.gov ID

NCT00158457

Collaborator

Gilead Sciences (Industry), Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection	Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) Drug: Efavirenz (EFV)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

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 Start Date :

Jun 1, 2004

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Traitement Ambulatoire, CHU de Fann	Dakar		Senegal
2	Service des Maladies Infectieuses, CHU de Fann	Dakar		Senegal

Sponsors and Collaborators

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