Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
Merck Sharp & Dohme Corp.
Pfizer
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01033760
First received: December 15, 2009
Last updated: February 4, 2014
Last verified: February 2014

December 15, 2009
February 4, 2014
April 2010
July 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01033760 on ClinicalTrials.gov Archive Site
  • Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Changes in cell-associated HIV-DNA between baseline and M24 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Evolution of the CD4 and CD8 between D0 and M24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Tolerability of trial treatments [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Number and type of ARV mutations in virological failures and change in CCR5 tropism [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infections
  • 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.
  • Experimental: arm 1
    darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
    Intervention: Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine
  • Active Comparator: arm 2
    darunavir, ritonavir, emtricitabine/tenofovir
    Intervention: Drug: darunavir; ritonavir; emtricitabine/tenofovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01033760
2009-014742-28, EudraCT
No
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
  • Pfizer
  • Janssen-Cilag Ltd.
Principal Investigator: Antoine CHERET, PH Hospital Tourcoing
Principal Investigator: Caroline LASCOUX-COMBE, PH Saint Louis Hospital, Paris
Study Chair: Laurence MEYER, Professor Methodologist, INSERM U1018
Principal Investigator: Bruno HOEN, Professor Saint Jacques Hospital, CHU Besançon
Principal Investigator: Isabelle RAVAUX, PH Conception Hospital, Marseille
Principal Investigator: Christine ROUZIOUX, Professor Virology Investigator, Necker Hospital Paris
Principal Investigator: Alain VENET, PH Immunology Investigator, INSERM U1012 Bicêtre
Principal Investigator: Daniel OLIVE, Professor Immunology Investigator, Cancerology Institut Marseille
Principal Investigator: Gianfranco PANCINO, PH Immunology Investigator, Pasteur Institut Paris
Principal Investigator: Brigitte AUTRAN, Professor Immunology Investiigator, INSERM U543 Paris
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP