Trial | NCT00158457  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Jun 30
2004
Study Completion
Dec 31
2006
Last Update
Jul 03
2007
Estimate

Drug Tenofovir (TDF)

Drug Emtricitabine (FTC)

Drug Efavirenz (EFV)

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
No Results Posted