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Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Gilead Sciences
Merck
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: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV-1 Infections
 Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine
Drug: darunavir; ritonavir; emtricitabine/tenofovir
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ 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 ]

Estimated Enrollment: 90
Study Start Date: April 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 1
darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
 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.
Active Comparator: arm 2
darunavir, ritonavir, emtricitabine/tenofovir
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033760

Locations
France
Hôpital Gustave Dron
Tourcoing, France, 59208
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Merck
Pfizer
Janssen-Cilag Ltd.
Investigators
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
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: 2009-014742-28, EudraCT
Study First Received: December 15, 2009
Last Updated: May 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary HIV-1 infection
antiretroviral treatment
HIV reservoirs
 HIV-DNA levels
randomized
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Darunavir
Tenofovir
Tenofovir disoproxil
 Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013