Trial | NCT01033760  Report issue

Title

Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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.
Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.

After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).

We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.
Study Started
Apr 30
2010
Primary Completion
Jul 31
2013
Study Completion
Dec 31
2013
Last Update
Feb 05
2014
Estimate

Drug raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

raltegravir (Isentress®): 400 mg bid. maraviroc (Celsentri®): 150 mg bid. darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.

Drug darunavir; ritonavir; emtricitabine/tenofovir

darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.

arm 1 Experimental

darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir

arm 2 Active Comparator

darunavir, ritonavir, emtricitabine/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
No Results Posted