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

Study Overview
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Brief Summary
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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
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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

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Tenofovir (TDF)
* Drug: Emtricitabine (FTC)
* Drug: Efavirenz (EFV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tenofovir (TDF)|nan|
|Drug: Emtricitabine (FTC)|nan|
|Drug: Efavirenz (EFV)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simplification regimen, HIV infection, Once a day, Naive patients, Sub-saharian Africa, Treatment Naive