Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

Overview

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 Title of Study: “Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2013

Detailed 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: arm 1
    • darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
  • Active Comparator: arm 2
    • darunavir, ritonavir, emtricitabine/tenofovir

Clinical Trial Outcome Measures

Primary Measures

  • To compare the 24-month impact of maximized vs. conventional HAART- on HIV reservoirs, as assessed by cell-associated HIV-DNA levels, in patients with acute or primary HIV-1 infection
    • Time Frame: 24 months

Secondary Measures

  • Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30
    • Time Frame: 30 months
  • Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24
    • Time Frame: 24 months
  • Changes in cell-associated HIV-DNA between baseline and M24
    • Time Frame: 24 Months
  • Evolution of the CD4 and CD8 between D0 and M24
    • Time Frame: 24 months
  • Tolerability of trial treatments
    • Time Frame: 24 months
  • Number and type of ARV mutations in virological failures and change in CCR5 tropism
    • Time Frame: 24 Months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ANRS, Emerging Infectious Diseases
  • Collaborator
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Antoine CHERET, PH, Principal Investigator, Tourcoing Hospital
    • Caroline LASCOUX-COMBE, PH, Principal Investigator, Saint Louis Hospital, Paris
    • Laurence MEYER, Professor, Study Chair, Methodologist, INSERM U1018
    • Bruno HOEN, Professor, Principal Investigator, Saint Jacques Hospital, CHU Besançon
    • Isabelle RAVAUX, PH, Principal Investigator, Conception Hospital, Marseille
    • Christine ROUZIOUX, Professor, Principal Investigator, Virology Investigator, Necker Hospital Paris
    • Alain VENET, PH, Principal Investigator, Immunology Investigator, INSERM U1012 Bicêtre
    • Daniel OLIVE, Professor, Principal Investigator, Immunology Investigator, Cancerology Institut Marseille
    • Gianfranco PANCINO, PH, Principal Investigator, Immunology Investigator, Pasteur Institut Paris
    • Brigitte AUTRAN, Professor, Principal Investigator, Immunology Investiigator, INSERM U543 Paris

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