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

NCT ID: NCT00196638

Last Updated: 2006-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2006-03-31

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.

Conditions

HIV Infections; Primary Acute Infection

Keywords

HIV infections; Primary acute infection; Interferon-alpha

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Antiretroviral combination (drugs)

Intervention Type: DRUG

Pegylated Interferon alpha (drug)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Dominique Emilie, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Antoine Béclère, Clamart, France

Genevieve Chene, MD, PhD

Role: STUDY_DIRECTOR

INSERM U593, Bordeaux, France.

Other Identifiers

ANRS 112 INTERPRIM

Identifier Type: -

Identifier Source: org_study_id