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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Schering-Plough |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00125814 |
The purpose of this study is to determine whether the adjunctional of interferon alfa to structured treatment interruptions correlated with a long time off treatment in HIV-1 infection.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Interferon alfa-2b Procedure: Structured treatment interruptions |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Multi-Center Trial to Evaluate the Efficacy and Safety of Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression (ANRS 105 INTERVAC) |
Estimated Enrollment: | 200 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | January 2005 |
The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection is associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart. In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving highly active antiretroviral therapy (HAART) now in whom treatment would not have been started based on current guidelines), the investigators evaluated whether the adjunctional of interferon alfa 2b to 3 structured treatment interruptions correlated with a long time off treatment. HAART was interrupted for 4 weeks, restarted and continued for 12 weeks. After 3 such cycles treatment was indefinitely suspended 48 weeks after study entry. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 6 months of interruption).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service de Medecine Interne | |
Clamart, France, 92140 |
Principal Investigator: | François Boue, MD | Hopital Antoine Beclere service de Medecine Interne Clamart France |
Study Chair: | Dominique Costagliola | INSERM U 720 |
Study ID Numbers: | ANRS 105 INTERVAC |
Study First Received: | August 1, 2005 |
Last Updated: | August 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00125814 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Interferon Alfa-2b HIV infections |
Interferon-alpha Virus Diseases Interferon Type I, Recombinant Sexually Transmitted Diseases, Viral HIV Infections Interferons |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Interferon Alfa-2a Interferon Alfa-2b Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Infection Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Lentivirus Infections Growth Inhibitors Angiogenesis Modulating Agents |