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CompletedNCT01033760Updated Feb 5, 2014

Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

A Phase 3 interventional study of raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine and darunavir; ritonavir; emtricitabine/tenofovir in HIV-1 Infections, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • HIV-1 Infections

Keywords

  • Primary HIV-1 infection
  • antiretroviral treatment
  • HIV reservoirs
  • HIV-DNA levels
  • randomized
  • Treatment Naive
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 90 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    arm 1

    darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir

    Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

  • Active comparator
    arm 2

    darunavir, ritonavir, emtricitabine/tenofovir

    Drug: darunavir; ritonavir; emtricitabine/tenofovir

Interventions

  • Drugraltegravir; 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.

  • Drugdarunavir; ritonavir; emtricitabine/tenofovir

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

06

What researchers measure

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

    Time frame: 24 months

Secondary outcomes

  1. Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30

    Time frame: 30 months

  2. Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24

    Time frame: 24 months

  3. Changes in cell-associated HIV-DNA between baseline and M24

    Time frame: 24 Months

  4. Evolution of the CD4 and CD8 between D0 and M24

    Time frame: 24 months

  5. Tolerability of trial treatments

    Time frame: 24 months

  6. Number and type of ARV mutations in virological failures and change in CCR5 tropism

    Time frame: 24 Months

07

Study locations

1 site
  • Hôpital Gustave Dron
    Tourcoing, 59208, France
08

References and documents

Publications

  • 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. PubMed 28708873 ↗
  • 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. PubMed 25701561 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01033760
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer, Janssen-Cilag Ltd.
Responsible party
Sponsor
First posted
Dec 16, 2009
Start date
Apr 2010
Primary completion
Jul 2013
Completion
Dec 2013
Last update
Feb 5, 2014

Study contacts

Antoine CHERET, PH
principal investigator · Tourcoing Hospital
Caroline LASCOUX-COMBE, PH
principal investigator · Saint Louis Hospital, Paris
Laurence MEYER, Professor
study chair · Methodologist, INSERM U1018
Bruno HOEN, Professor
principal investigator · Saint Jacques Hospital, CHU Besançon
Isabelle RAVAUX, PH
principal investigator · Conception Hospital, Marseille
Christine ROUZIOUX, Professor
principal investigator · Virology Investigator, Necker Hospital Paris
Alain VENET, PH
principal investigator · Immunology Investigator, INSERM U1012 Bicêtre
Daniel OLIVE, Professor
principal investigator · Immunology Investigator, Cancerology Institut Marseille
Gianfranco PANCINO, PH
principal investigator · Immunology Investigator, Pasteur Institut Paris
Brigitte AUTRAN, Professor
principal investigator · Immunology Investiigator, INSERM U543 Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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