Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 5, 2014
February 1, 2014
3.3 years
December 15, 2009
February 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 months
Secondary Outcomes (6)
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30
30 months
Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24
24 months
Changes in cell-associated HIV-DNA between baseline and M24
24 Months
Evolution of the CD4 and CD8 between D0 and M24
24 months
Tolerability of trial treatments
24 months
- +1 more secondary outcomes
Study Arms (2)
arm 1
EXPERIMENTALdarunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir
arm 2
ACTIVE COMPARATORdarunavir, ritonavir, emtricitabine/tenofovir
Interventions
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.
darunavir (Prezista®): 800 mg QD. ritonavir tablet (Norvir®): 100 mg QD. tenofovir/emtricitabine (Truvada®): one 245/200 mg tablet QD.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Gilead Sciencescollaborator
- Merck Sharp & Dohme LLCcollaborator
- Pfizercollaborator
- Janssen-Cilag Ltd.collaborator
Study Sites (1)
Hôpital Gustave Dron
Tourcoing, 59208, France
Related Publications (2)
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.
PMID: 28708873DERIVEDCheret 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.
PMID: 25701561DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
April 1, 2010
Primary Completion
July 1, 2013
Study Completion
December 1, 2013
Last Updated
February 5, 2014
Record last verified: 2014-02