Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts

• Status: Completed
• Trial end date: 2013-01-07
• Target enrollment: 0
• Participant gender: All

Summary

A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Treatments: Atazanavir Sulfate; Darunavir

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