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

This study is no longer recruiting patients.

Sponsors and Collaborators: French National Agency for Research on AIDS and Viral Hepatitis
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

Purpose

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 and 48 weeks of treatment.

Condition Intervention Phase
HIV Infection
 Drug: Tenofovir (TDF)
 Drug: Emtricitabine (FTC)
 Drug: Efavirenz (EFV)
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: 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
Secondary Outcomes: - 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
Expected Total Enrollment:  40

Study start: June 2004
Last follow-up: December 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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

Location Information


Senegal
      Service des Maladies Infectieuses, CHU de Fann, Dakar,  Senegal

      Centre de Traitement Ambulatoire, CHU de Fann, Dakar,  Senegal

Study chairs or principal investigators

Roland Landman,  Study Chair,  IMEA- Hôpital Bichat Claude Bernard, France   
Papa Salif Sow,  Principal Investigator,  CHU de Fann, Dakar   

More Information

Study ID Numbers:  ANRS 1207; IMEA 025
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158457
Health Authority: Senegal: Ministere de la sante
ClinicalTrials.gov processed this record on 2005-09-13

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