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

This study has been terminated.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00196638
First received: September 12, 2005
Last updated: August 28, 2006
Last verified: August 2006
  Purpose

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


Condition Intervention Phase
HIV Infections
Primary Acute Infection
Drug: Antiretroviral combination (drugs)
Drug: Pegylated Interferon alpha (drug)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection.ANRS 112 INTERPRIM

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Estimated Enrollment: 90
Study Start Date: May 2002
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196638

Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
Investigators
Principal Investigator: Dominique Emilie, MD Hôpital Antoine Béclère, Clamart, France
Study Director: Genevieve Chene, MD, PhD INSERM U593, Bordeaux, France.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00196638     History of Changes
Other Study ID Numbers: ANRS 112 INTERPRIM
Study First Received: September 12, 2005
Last Updated: August 28, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections
Primary acute infection
Interferon-alpha

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 14, 2014