Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01033760
• Date of registration: 15/12/2009
• Primary sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Public title: Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)
• Scientific title: Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)
• Date of first enrolment: April 2010
• Target sample size: 90
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01033760
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

France

Contacts

• Name: Isabelle RAVAUX, PH
• Affiliation: Conception Hospital, Marseille

• Name: Antoine CHERET, PH
• Affiliation: Hospital Tourcoing

• Name: Daniel OLIVE, Professor
• Affiliation: Immunology Investigator, Cancerology Institut Marseille

• Name: Alain VENET, PH
• Affiliation: Immunology Investigator, INSERM U1012 Bicêtre

• Name: Gianfranco PANCINO, PH
• Affiliation: Immunology Investigator, Pasteur Institut Paris

• Name: Brigitte AUTRAN, Professor
• Affiliation: Immunology Investiigator, INSERM U543 Paris

• Name: Laurence MEYER, Professor
• Affiliation: Methodologist, INSERM U1018

• Name: Bruno HOEN, Professor
• Affiliation: Saint Jacques Hospital, CHU Besançon

• Name: Caroline LASCOUX-COMBE, PH
• Affiliation: Saint Louis Hospital, Paris

• Name: Christine ROUZIOUX, Professor
• Affiliation: Virology Investigator, Necker Hospital Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV-1 Infections

Intervention(s)

Drug: darunavir; ritonavir; emtricitabine/tenofovir

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

Primary Outcome(s)

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 Outcome(s)

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]

Number and type of ARV mutations in virological failures and change in CCR5 tropism [Time Frame: 24 Months]

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

Tolerability of trial treatments [Time Frame: 24 months]

Secondary ID(s)

2009-014742-28

EudraCT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences

Janssen-Cilag Ltd.

Merck

Pfizer