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

Tracking Information

First Received Date ^ICMJE

December 15, 2009

Last Updated Date

May 22, 2012

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01033760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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 *

Not Provided

* 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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01033760

Other Study ID Numbers ^ICMJE

2009-014742-28, EudraCT

Has Data Monitoring Committee

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
Pfizer
Janssen-Cilag Ltd.

Investigators ^ICMJE

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

Information Provided By

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Verification Date

May 2012

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

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