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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Hoffmann-La Roche |
Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00196638 |
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 II Phase III |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicentric Trial Comparing Three Therapeutical Strategies in Patients With Acute Primary HIV Infection.ANRS 112 INTERPRIM |
Estimated Enrollment: | 90 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
Study ID Numbers: | ANRS 112 INTERPRIM |
First Received: | September 12, 2005 |
Last Updated: | August 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00196638 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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