Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 3

Conditions: HIV-1 Infections

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01033760

2009-014742-28

EudraCT (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

arm 1

Experimental group

Description:

darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir

Treatment:

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

arm 2

Active Comparator group

Description:

darunavir, ritonavir, emtricitabine/tenofovir

Treatment:

Drug: darunavir; ritonavir; emtricitabine/tenofovir