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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 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Interferon Alfa-2b HIV infections |
Interferon-alpha Sexually Transmitted Diseases, Viral Interferon Type I, Recombinant Immunologic Factors Acquired Immunodeficiency Syndrome Interferons Angiogenesis Inhibitors Antiviral Agents |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Interferon Alfa-2a Retroviridae Infections Interferon Alfa-2b |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Interferon Type I, Recombinant Slow Virus Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Infection Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections Interferon-alpha RNA Virus Infections |
Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Interferons Antiviral Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Interferon Alfa-2a Interferon Alfa-2b |