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Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection

Primary Purpose

HIV Infections, Primary Acute Infection

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Antiretroviral combination (drugs)

Pegylated Interferon alpha (drug)

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV infections, Primary acute infection, Interferon-alpha

Eligibility Criteria

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

Inclusion Criteria: P24 antigen with positive neutralization or positive plasma HIV RNA Negative or not complete Western Blot With symptoms or not Written informed consent Exclusion Criteria: Previous antiretroviral treatment Pregnancy Biological abnormalities Hepatitis C or B

Sites / Locations

Outcomes

Primary Outcome Measures

Plasma HIV RNA at Week 92 and 96 (mean)

Secondary Outcome Measures

Plasma HIV RNA kinetics after treatment interruption

CD4 cell count

Proviral DNA

Adherence

Full Information

NCT ID

NCT00196638

First Posted

September 12, 2005

Last Updated

August 28, 2006

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00196638

Brief Title

Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection

Official Title

Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection.ANRS 112 INTERPRIM

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Terminated

Study Start Date

May 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

Treatment of acute primary HIV infection may improve long-term outcome. However, optimal treatment is still debated. The ANRS 112-INTERPRIM trial evaluates three different therapeutical strategies, combining permanent or intermittent HAART and a cytokine, interferon alpha, in order to determine which combination allows the best control of HIV viremia after 24 weeks of antiretroviral treatment interruption

Detailed Description

Treatment of acute primary HIV infection may improve long-term outcome. However, optimal treatment is still debated. The main objective of this multicentric randomized phase II/III study is to compare HIV viremia 92 and 96 weeks after acute primary HIV infection, between patients treated with 3 different strategies. In the first group, patients receive antiretroviral drugs (HAART) continuously up to week 72. In the second group, patients receive HAART continuously up to week 36, then intermittently up to week 72. In the third group, patients receive HAART as in group II, and pegylated interferon alpha is administered for the initial 14 weeks, then for 3 weeks at each of the 3 HAART interruption between week 36 and week 72. All patients are monitored without any HAART up to week 96. Enrolled patients have circulating p24 antigen and/or HIV viremia, an uncompleted HIV western blot, between 18 and 65 years old, and agree to participate to the study. They should have received no antiretroviral drugs, not be pregnant, without neuro-psychological or autoimmune disorders, without chronic hepatitis. Secondary objectives of the study are: the quality of immune restoration, the anti-HIV immune response, safety and adhesion to treatment. A total of 90 patients (30 in each group) have been enrolled.

6. Conditions and Keywords

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

HIV Infections, Primary Acute Infection

Keywords

HIV infections, Primary acute infection, Interferon-alpha

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Antiretroviral combination (drugs)

Intervention Type

Drug

Intervention Name(s)

Pegylated Interferon alpha (drug)

Primary Outcome Measure Information:

Title

Plasma HIV RNA at Week 92 and 96 (mean)

Secondary Outcome Measure Information:

Title

Plasma HIV RNA kinetics after treatment interruption

Title

CD4 cell count

Title

Proviral DNA

Title

Adherence

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique Emilie, MD

Organizational Affiliation

Hôpital Antoine Béclère, Clamart, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Genevieve Chene, MD, PhD

Organizational Affiliation

INSERM U593, Bordeaux, France.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection

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