Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

NCT ID: NCT01033760

Last Updated: 2014-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

HIV-1 Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm 1

darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir

Group Type: EXPERIMENTAL

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

Intervention Type: DRUG

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.

arm 2

darunavir, ritonavir, emtricitabine/tenofovir

Group Type: ACTIVE_COMPARATOR

darunavir; ritonavir; emtricitabine/tenofovir

Intervention Type: DRUG

darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine CHERET, PH

Role: PRINCIPAL_INVESTIGATOR

Tourcoing Hospital

Caroline LASCOUX-COMBE, PH

Role: PRINCIPAL_INVESTIGATOR

Saint Louis Hospital, Paris

Laurence MEYER, Professor

Role: STUDY_CHAIR

Methodologist, INSERM U1018

Bruno HOEN, Professor

Role: PRINCIPAL_INVESTIGATOR

Saint Jacques Hospital, CHU Besançon

Isabelle RAVAUX, PH

Role: PRINCIPAL_INVESTIGATOR

Conception Hospital, Marseille

Christine ROUZIOUX, Professor

Role: PRINCIPAL_INVESTIGATOR

Virology Investigator, Necker Hospital Paris

Alain VENET, PH

Role: PRINCIPAL_INVESTIGATOR

Immunology Investigator, INSERM U1012 Bicêtre

Daniel OLIVE, Professor

Role: PRINCIPAL_INVESTIGATOR

Immunology Investigator, Cancerology Institut Marseille

Gianfranco PANCINO, PH

Role: PRINCIPAL_INVESTIGATOR

Immunology Investigator, Pasteur Institut Paris

Brigitte AUTRAN, Professor

Role: PRINCIPAL_INVESTIGATOR

Immunology Investiigator, INSERM U543 Paris

Locations

Hôpital Gustave Dron

Tourcoing, , France

Countries

France

References

Cheret A, Durier C, Melard A, Ploquin M, Heitzmann J, Lecuroux C, Avettand-Fenoel V, David L, Pialoux G, Chennebault JM, Muller-Trutwin M, Goujard C, Rouzioux C, Meyer L; ANRS OPTIPRIM study group. Impact of early cART on HIV blood and semen compartments at the time of primary infection. PLoS One. 2017 Jul 14;12(7):e0180191. doi: 10.1371/journal.pone.0180191. eCollection 2017.

Reference Type: DERIVED

PMID: 28708873 (View on PubMed)

Cheret A, Nembot G, Melard A, Lascoux C, Slama L, Miailhes P, Yeni P, Abel S, Avettand-Fenoel V, Venet A, Chaix ML, Molina JM, Katlama C, Goujard C, Tamalet C, Raffi F, Lafeuillade A, Reynes J, Ravaux I, Hoen B, Delfraissy JF, Meyer L, Rouzioux C; OPTIPRIM ANRS Study Group. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015 Apr;15(4):387-96. doi: 10.1016/S1473-3099(15)70021-6. Epub 2015 Feb 18.

Reference Type: DERIVED

PMID: 25701561 (View on PubMed)

Other Identifiers

EudraCT

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-014742-28

Identifier Type: -

Identifier Source: org_study_id