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Sponsored by: |
Schering-Plough |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00005012 |
The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Peginterferon alfa-2b |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Official Title: | Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART |
Estimated Enrollment: | 250 |
Study Start Date: | March 2000 |
Estimated Study Completion Date: | September 2000 |
At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Study ID Numbers: | B010, P00737 |
Study First Received: | March 29, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005012 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Interferon Alfa-2b Lymphocyte Transformation CD4 Lymphocyte Count RNA, Viral |
Virus Inhibitors Anti-HIV Agents Viral Load |
Interferon-alpha Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Interferons Antiviral Agents Immunologic Deficiency Syndromes |
Virus Diseases HIV Infections Sexually Transmitted Diseases Peginterferon alfa-2b Interferon Alfa-2a Retroviridae Infections Interferon Alfa-2b |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Peginterferon alfa-2b Retroviridae Infections |