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Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

Primary Purpose

HIV-1 Infections

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

darunavir; ritonavir; emtricitabine/tenofovir

About this trial

This is an interventional treatment trial for HIV-1 Infections focused on measuring Primary HIV-1 infection, antiretroviral treatment, HIV reservoirs, HIV-DNA levels, randomized, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Gustave Dron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

arm 1

arm 2

Arm Description

darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir

darunavir, ritonavir, emtricitabine/tenofovir

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Evolution of the CD4 and CD8 between D0 and M24

Tolerability of trial treatments

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

Full Information

NCT ID

NCT01033760

First Posted

December 15, 2009

Last Updated

February 4, 2014

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer, Janssen-Cilag Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01033760

Brief Title

Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

Official Title

Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer, Janssen-Cilag Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1 Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

arm 1

Arm Type

Experimental

Arm Description

darunavir, ritonavir, emtricitabine/tenofovir, maraviroc, raltegravir

Arm Title

arm 2

Arm Type

Active Comparator

Arm Description

darunavir, ritonavir, emtricitabine/tenofovir

Intervention Type

Drug

Intervention Name(s)

raltegravir; maraviroc; darunavir; ritonavir; tenofovir/emtricitabine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

darunavir; ritonavir; emtricitabine/tenofovir

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Time Frame

30 months

Title

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

Time Frame

24 months

Title

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

Time Frame

24 Months

Title

Evolution of the CD4 and CD8 between D0 and M24

Time Frame

24 months

Title

Tolerability of trial treatments

Time Frame

24 months

Title

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

Time Frame

24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: