Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM) - Full Text View

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

Drug Information available for: Emtricitabine Tenofovir Ritonavir Tenofovir Disoproxil Fumarate Darunavir Maraviroc Raltegravir Darunavir ethanolate Raltegravir potassium

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 ]


Enrollment:	90
Study Start Date:	April 2010
Study Completion Date:	December 2013
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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.

Pfizer

Janssen-Cilag Ltd.

Investigators


Principal Investigator:	Antoine CHERET, PH	Tourcoing Hospital
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chéret A, Nembot G, Mélard 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, Hoën 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.


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:	February 4, 2014
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:


Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Raltegravir Potassium Darunavir Maraviroc Tenofovir	Ritonavir Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action HIV Protease Inhibitors Protease Inhibitors CCR5 Receptor Antagonists Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016