Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: March 29, 2000
Last updated: June 23, 2005
Last Verified: August 2000
History of Changes
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).
Drug : Peginterferon alfa-2b
Primary Purpose: Treatment
|Official Title:||Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||March 2000|
|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.Eligibility
|Ages Eligible for Study:||Child, Adult, Senior|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients may be eligible for this study if they:
- Have HIV levels of more than 2000 copies/ml.
- Have failed their current HAART (had a significant increase in their HIV levels with HAART).
- Have a CD4 cell count greater than 200 cells/microL.
- Have had more than 6 months of HAART.
- Have been on their current HAART for at least 6 weeks.
- Agree to use an effective method of birth control during the study.
- Have a history of a serious mental disorder.
- Are allergic to interferons.
- Are pregnant or breast-feeding.
- Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005012
Locations Show More
|United States, California|
|East Bay AIDS Ctr|
|Berkeley, California, United States, 94705|
|United States, District of Columbia|
|Georgetown Univ Med Ctr|
|Washington, District of Columbia, United States, 20007|
|Dupont Circle Physicians Group|
|Washington, District of Columbia, United States, 200091104|
|United States, Florida|
|IDC Research Initiative|
|Altamonte Springs, Florida, United States, 32701|
|Duval County Health Department|
|Jacksonville, Florida, United States, 32206|
|Univ of Miami School of Medicine|
|Miami, Florida, United States, 33136|
|Infectious Diseases Associates|
|Sarasota, Florida, United States, 34239|
|United States, Georgia|
|Piedmont Physicians at Vinings|
|Atlanta, Georgia, United States, 30339|
|United States, Illinois|
|TRIAD Health Practice|
|Chicago, Illinois, United States, 60657|
|United States, Maryland|
|Univ of Maryland Institute of Human Virology|
|Baltimore, Maryland, United States, 212011192|
|United States, Massachusetts|
|New England Med Ctr / Div of Geo Med & Infect Disease|
|Boston, Massachusetts, United States, 02111|
|United States, Minnesota|
|St. Paul, Minnesota, United States, 55101|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Southwestern New Jersey AIDS Clinical Trials|
|Camden, New Jersey, United States, 08103|
|East Orange Veterans Administration Med Ctr|
|East Orange, New Jersey, United States, 07018|
|United States, New York|
|Beth Israel Med Ctr|
|New York, New York, United States, 10003|
|United States, Ohio|
|Univ Hosps of Cleveland|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|MCP Hahnemann Univ|
|Philadelphia, Pennsylvania, United States, 19102|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Amelia Ct Clinic|
|Dallas, Texas, United States, 75235|
|Joseph C Gathe|
|Houston, Texas, United States, 77004|
|San Juan VAMC|
|San Juan, Puerto Rico, 009265800|
Sponsors and CollaboratorsSchering-Plough
|ClinicalTrials.gov Identifier:||NCT00005012 History of Changes|
|Other Study ID Numbers:||B010|
|Study First Received:||March 29, 2000|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Interferon Alfa-2b
CD4 Lymphocyte Count
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.