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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

September 12, 2005
August 28, 2006
May 2002
Not Provided
Plasma HIV RNA at Week 92 and 96 (mean)
Same as current
Complete list of historical versions of study NCT00196638 on ClinicalTrials.gov Archive Site
  • Plasma HIV RNA kinetics after treatment interruption
  • CD4 cell count
  • Proviral DNA
  • Adherence
Same as current
Not Provided
Not Provided
 
Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection
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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Primary Acute Infection
  • Drug: Antiretroviral combination (drugs)
  • Drug: Pegylated Interferon alpha (drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
March 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00196638
ANRS 112 INTERPRIM
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
Principal Investigator: Dominique Emilie, MD Hôpital Antoine Béclère, Clamart, France
Study Director: Genevieve Chene, MD, PhD INSERM U593, Bordeaux, France.
French National Agency for Research on AIDS and Viral Hepatitis
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP