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

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00158457
First received: September 8, 2005
Last updated: July 2, 2007
Last verified: July 2007

September 8, 2005
July 2, 2007
June 2004
Not Provided
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 [ Time Frame: S48 ]
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
Complete list of historical versions of study NCT00158457 on ClinicalTrials.gov Archive Site
  • Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml [ Time Frame: S24 and S96 ]
  • Viral load evolution [ Time Frame: S24 and S48 ]
  • Genotype resistance profile evaluation failing patients [ Time Frame: S24, S48, S96 ]
  • Immune benefits of the combination
  • Plasma concentrations of FTC, TDF and EFV [ Time Frame: S4 ]
  • Adverse events clinic and lipids
  • Compliance [ Time Frame: S48 and S96 ]
  • - Reduction of the viral load at week 24 and percentage of patients with a viral load lower than 50 copies/ml
  • - Viral load evolution at S24 and S48
  • - Genotype resistance profile evaluation failing patients
  • - Immune benefits of the combination
  • - Plasma concentrations of FTC, TDF and EFV at S4.
  • - Adverse events clinic and lipids
  • - Compliance
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: Tenofovir (TDF)
  • Drug: Emtricitabine (FTC)
  • Drug: Efavirenz (EFV)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Senegal
 
NCT00158457
ANRS 1207, IMEA 025
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
  • Gilead Sciences
  • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study Chair: Roland Landman IMEA- Hôpital Bichat Claude Bernard, France
Principal Investigator: Papa Salif Sow CHU de Fann, Dakar
French National Agency for Research on AIDS and Viral Hepatitis
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP