Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborators: Gilead Sciences; Janssen-Cilag Ltd.; Merck Sharp & Dohme Corp.; Pfizer
• Treatments: Darunavir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc; Raltegravir Potassium; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Patients with acute or primary HIV-1 infection

• Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24.

• Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and < 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.

• Symptomatic Primary infection or CD4 <500/mm3

• written informed consent

• ≥ 18 years old

Exclusion Criteria:

• Prior post exposure antiretroviral treatment within six months before enrolment

• Pregnancy or breast-feeding

• HIV-2 infection

• Current malignancy

• Prothrombin time < 50%

• Creatinine clearance < 60 ml/min

• ASAT, ALAT or bilirubin ≥10*N

• Platelets < 25000/mm3