Clinical trial NCT00158457: Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Keywords: Simplification regimen
HIV infection
Once a day
Naive patients
Sub-saharian Africa
Treatment Naive
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Gilead Sciences
name: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: S48
Secondary outcomes:
measure: Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml
timeFrame: S24 and S96
measure: Viral load evolution
timeFrame: S24 and S48
measure: Genotype resistance profile evaluation failing patients
timeFrame: S24, S48, S96
measure: Immune benefits of the combination
measure: Plasma concentrations of FTC, TDF and EFV
timeFrame: S4
measure: Adverse events clinic and lipids
measure: Compliance
timeFrame: S48 and S96
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Centre de Traitement Ambulatoire, CHU de Fann
city: Dakar
country: Senegal
facility: Service des Maladies Infectieuses, CHU de Fann
Study officials:
affiliation: IMEA- Hôpital Bichat Claude Bernard, France
name: Roland Landman
role: STUDY_CHAIR
affiliation: CHU de Fann, Dakar
name: Papa Salif Sow
role: PRINCIPAL_INVESTIGATOR
References: