Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)
HIV Infections, AIDS
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV infections, Fuzeon, Truvada, AIDS, Treatment Naive
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Service des Maladies Infectieuses A Hôpital Bichat-Claude Bernard
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intensification
Standard
lopinavir or efavirenz and emtricitabine/tenofovir and intensification with enfuvirtide (week 0 to 24)
lopinavir or efavirenz and emtricitabine/tenofovir