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

August 28, 2006 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

90

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Plasma HIV RNA at Week 92 and 96 (mean)

Secondary Outcome Measures

Outcome Measure
Adherence
CD4 cell count
Plasma HIV RNA kinetics after treatment interruption
Proviral DNA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Dominique Emilie, MD, Hôpital Antoine Béclère, Clamart, France
  • Study Director: Genevieve Chene, MD, PhD, INSERM U593, Bordeaux, France.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

August 29, 2006

Last Update Submitted That Met QC Criteria

August 28, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 112 INTERPRIM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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