Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
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|ClinicalTrials.gov Identifier: NCT01033760|
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : February 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infections||Drug: raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine Drug: darunavir; ritonavir; emtricitabine/tenofovir||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||December 2013|
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.
- 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 ]
- Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30 [ Time Frame: 30 months ]
- Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24 [ Time Frame: 24 months ]
- Changes in cell-associated HIV-DNA between baseline and M24 [ Time Frame: 24 Months ]
- Evolution of the CD4 and CD8 between D0 and M24 [ Time Frame: 24 months ]
- Tolerability of trial treatments [ Time Frame: 24 months ]
- Number and type of ARV mutations in virological failures and change in CCR5 tropism [ Time Frame: 24 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033760
|Hôpital Gustave Dron|
|Tourcoing, France, 59208|
|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|