Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

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.

Conditions

• HIV-1 Infections

Interventions

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.

Sponsors & Collaborators

• Gilead Sciences

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Pfizer

  collaborator INDUSTRY

• Janssen-Cilag Ltd.

  collaborator INDUSTRY

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Antoine CHERET, PH · Tourcoing Hospital

• Caroline LASCOUX-COMBE, PH · Saint Louis Hospital, Paris

• Laurence MEYER, Professor · Methodologist, INSERM U1018

• Bruno HOEN, Professor · Saint Jacques Hospital, CHU Besançon

• Isabelle RAVAUX, PH · Conception Hospital, Marseille

• Christine ROUZIOUX, Professor · Virology Investigator, Necker Hospital Paris

• Alain VENET, PH · Immunology Investigator, INSERM U1012 Bicêtre

• Daniel OLIVE, Professor · Immunology Investigator, Cancerology Institut Marseille

• Gianfranco PANCINO, PH · Immunology Investigator, Pasteur Institut Paris

• Brigitte AUTRAN, Professor · Immunology Investiigator, INSERM U543 Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2013-07-31

Completion

2013-12-31

Countries

• France

Study Locations