Skip to main content
OpenTrials
Completed

NCT Number: NCT01033760

Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Gustave Dron

Tourcoing, 59208, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

Drug

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.

darunavir; ritonavir; emtricitabine/tenofovir

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30

    Time frame: 30 months

  2. Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24

    Time frame: 24 months

  3. Changes in cell-associated HIV-DNA between baseline and M24

    Time frame: 24 Months

  4. Evolution of the CD4 and CD8 between D0 and M24

    Time frame: 24 months

  5. Tolerability of trial treatments

    Time frame: 24 months

  6. Number and type of ARV mutations in virological failures and change in CCR5 tropism

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Gilead Sciences
  • Janssen-Cilag Ltd.
  • Merck Sharp & Dohme LLC
  • Pfizer

Registry information

Official study title

Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 16, 2009
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.