Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts (DATA)
HIV-1 Infection, Immunosuppression-related Infectious Disease
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring naives, CD4 < 200 cell/mm3, Atazanavir, Darunavir
Eligibility Criteria
Inclusion Criteria
- Male or female, aged > 18 years of age
- HIV-1 infection determined by a positive ELISA and confirmed by Western blot
- Plasma HIV-RNA > 1 000 c/mL
- CD4+T cell count < =200 cells/mm3 at the time of screening, or < =250 cells/mm3 if the CD4 count was <200 cells/mm3 12 weeks before screening
- Women of childbearing potential must agree to use an effective method of barrier contraception or have documented sterility
- Subjects must have medical insurance throught the Securite Sociale
- Ability to understand and provide written informed consent
Exclusion Criteria
- Acute opportunistic infection within the past two weeks
- HIV-2 infection
- Pregnant woman
- Any subject with drug resistance mutations at screening
- Any subject with a grade 3 or greater clinical or laboratory adverse event at screening
- Any subject who has received antiretoviral therapy except for prevention of mother to child transmission and patients who has received post exposure prophylaxis for a a month or less
- Calculated creatinine clearance < 60/mL as estimated by the Cockcroft- Gault equation
- Patients in the opinion of the investigator that are unlikley to be able to follow study instructions
- Any subject unable to take antiretroviral medication for whatever reason
- Any subject taking a treatment or medication that is contraindicated when co-administered with any arm or drug in the treatment
Sites / Locations
- Hopital Zobda Quitman
- Centre Hospitalier D'Argenteuil
- Hopital Saint-Jacques
- Hopital Avicenne
- Hopital Jean Verdier
- Hopital Saint-Andre
- Chu Cote de Nacre
- Hopital Louis Mourier
- Hopital Le Bocage
- Hopital Raymond Poincare
- C.H.D de Vendee
- Hopital Dupuytren
- Hopital Sainte-Marguerite
- Centre Hospitalier de Melun
- Hopital L'Archet
- Hopital Lariboisiere
- Hopital Saint Antoine
- Hopital Pitie-Salpetriere
- Hopital Necker
- Hopital Bichat
- Hopital Tenon
- Hopital Pitie-Salpetriere
- Hopital Cochin
- Hopital Europeen Georges Pompidou
- Hopital Saint-Jean Roussillon
- Hopital Rene Dubos
- C.H.R.A
- Hopital Civil
- Hopital Gustave Dron
- Hopital Bretonneau
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
ATAZANAVIR
DARUNAVIR
The patient included in this Group 1 will receive their first antiretroviral regimen included : ATV + TDF/FTC (or Abacavir/Lamivudine, [ABC/3TC], if contre indicated of TDF/FTC) The dose : atazanavir/ritonavir 300/100mg/day and TDF/FTC 245 /200 mg day, 3 pills once a day, during 48 weeks during a meal
The patients included in this Group 2 will receive their first antiretroviral regimen included Group 2 : DRV+ TDF/FTC (or ABC/3TC if contre-indicated of TDF/FTC) The dose : darunavir/ritonavir 800/100mg/day and TDF/FTC 245 /200 mg day, 4 pills once a day, during 48 weeks during a meal