Status:
COMPLETED
Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Hoffmann-La Roche
Gilead Sciences
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretrovi...
Detailed Description
The purpose of this randomized, open-label study is to evaluate the immunological efficacy of two first-line strategies of antiretroviral therapy: 1. emtricitabine/tenofovir disoproxil fumarate cofor...
Eligibility Criteria
Inclusion
- Antiretroviral naïve HIV-1 infected patients
- CD4 cell count below 100 per mm3, or CD4 cell count below 200/mm3 and past history or presence of B or C(AIDS defining)event
- Signed informed consent
Exclusion
- Pregnancy; breast feeding
- Coinfection with HIV-2 or infection with HIV-1 subtype O
- Antiretroviral pretreated patients
- Neoplasia disease currently treated with chemotherapy or radiotherapy
- Severe liver failure
- Treatment with cytokines or HIV vaccine trial
- One or more of the following biological abnormalities: hemoglobin below 10 g/dl, Neutrophils below 750 per mm3, thrombocytopenia below 50000 per mm3, creatinine clearance below 60 ml per min, Liver Function Tests over 3 Upper Limit of Normal
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00302822
Start Date
April 1 2006
End Date
December 1 2009
Last Update
July 10 2013
Active Locations (1)
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1
Service des Maladies Infectieuses A Hôpital Bichat-Claude Bernard
Paris, France, 75018