Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

NCT01033760

Last updated date
Study Location
Hôpital Gustave Dron
Tourcoing, , 59208, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1 Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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HIV-1 InfectionsOptimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
NCT01033760
  1. Tourcoing,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
Official Title  ICMJE Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infections
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2009)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01033760
Other Study ID Numbers  ICMJE 2009-014742-28
EudraCT ( Registry Identifier: 2009-014742-28 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor  ICMJE French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators  ICMJE
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
  • Pfizer
  • Janssen-Cilag Ltd.
Investigators  ICMJE
Principal Investigator:Antoine CHERET, PHTourcoing Hospital
Principal Investigator:Caroline LASCOUX-COMBE, PHSaint Louis Hospital, Paris
Study Chair:Laurence MEYER, ProfessorMethodologist, INSERM U1018
Principal Investigator:Bruno HOEN, ProfessorSaint Jacques Hospital, CHU Besançon
Principal Investigator:Isabelle RAVAUX, PHConception Hospital, Marseille
Principal Investigator:Christine ROUZIOUX, ProfessorVirology Investigator, Necker Hospital Paris
Principal Investigator:Alain VENET, PHImmunology Investigator, INSERM U1012 Bicêtre
Principal Investigator:Daniel OLIVE, ProfessorImmunology Investigator, Cancerology Institut Marseille
Principal Investigator:Gianfranco PANCINO, PHImmunology Investigator, Pasteur Institut Paris
Principal Investigator:Brigitte AUTRAN, ProfessorImmunology Investiigator, INSERM U543 Paris
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date February 2014

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