Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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