search
Back to results

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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 3
Locations
Senegal
Study Type
Interventional
Intervention
Tenofovir (TDF)
Emtricitabine (FTC)
Efavirenz (EFV)
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Simplification regimen, HIV infection, Once a day, Naive patients, Sub-saharian Africa, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de Traitement Ambulatoire, CHU de Fann
  • Service des Maladies Infectieuses, CHU de Fann

Outcomes

Primary Outcome Measures

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 Outcome Measures

Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml
Viral load evolution
Genotype resistance profile evaluation failing patients
Immune benefits of the combination
Plasma concentrations of FTC, TDF and EFV
Adverse events clinic and lipids
Compliance

Full Information

First Posted
September 8, 2005
Last Updated
July 2, 2007
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Gilead Sciences, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
search

1. Study Identification

Unique Protocol Identification Number
NCT00158457
Brief Title
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

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Gilead Sciences, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Simplification regimen, HIV infection, Once a day, Naive patients, Sub-saharian Africa, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tenofovir (TDF)
Intervention Type
Drug
Intervention Name(s)
Emtricitabine (FTC)
Intervention Type
Drug
Intervention Name(s)
Efavirenz (EFV)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml
Time Frame
S24 and S96
Title
Viral load evolution
Time Frame
S24 and S48
Title
Genotype resistance profile evaluation failing patients
Time Frame
S24, S48, S96
Title
Immune benefits of the combination
Title
Plasma concentrations of FTC, TDF and EFV
Time Frame
S4
Title
Adverse events clinic and lipids
Title
Compliance
Time Frame
S48 and S96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Landman
Organizational Affiliation
IMEA- Hôpital Bichat Claude Bernard, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Papa Salif Sow
Organizational Affiliation
CHU de Fann, Dakar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Traitement Ambulatoire, CHU de Fann
City
Dakar
Country
Senegal
Facility Name
Service des Maladies Infectieuses, CHU de Fann
City
Dakar
Country
Senegal

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs