Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)
Phase 3
Completed
- Conditions
- HIV Infection
- Registration Number
- NCT00158457
- Lead Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Centre de Traitement Ambulatoire, CHU de Fann
🇸🇳Dakar, Senegal
Service des Maladies Infectieuses, CHU de Fann
🇸🇳Dakar, Senegal