Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

HIV-1 Infections Clinical Trial

Official title:

Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033760
• Other study ID #: 2009-014742-28
• Secondary ID: EudraCT
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2009
• Last updated: February 4, 2014
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1 Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Gustave Dron	Tourcoing

Sponsors (5)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Gilead Sciences, Janssen-Cilag Ltd., Merck Sharp & Dohme Corp., Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plasma HIV-RNA levels and proportion of patients with plasma viral load < 50 copies/ml at M12, M24 and M30		30 months	No
Secondary	Plasma HIV-RNA levels and proportion of patients with plasma viral load < 5 copies/ml at M24		24 months	No
Secondary	Changes in cell-associated HIV-DNA between baseline and M24		24 Months	No
Secondary	Evolution of the CD4 and CD8 between D0 and M24		24 months	No
Secondary	Tolerability of trial treatments		24 months	Yes
Secondary	Number and type of ARV mutations in virological failures and change in CCR5 tropism		24 Months	Yes