Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
Antiviral Activity and Tolerability of PEG-Intron in HIV-Infected Subjects Failing HAART
2 other identifiers
interventional
250
2 countries
22
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Mar 2000
Shorter than P25 for phase_2 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2000
CompletedFirst Submitted
Initial submission to the registry
March 29, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 2000
March 29, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients will not be eligible for this study if they:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Schering-Ploughlead
Study Sites (22)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Duval County Health Department
Jacksonville, Florida, 32206, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
Piedmont Physicians at Vinings
Atlanta, Georgia, 30339, United States
TRIAD Health Practice
Chicago, Illinois, 60657, United States
Univ of Maryland Institute of Human Virology
Baltimore, Maryland, 212011192, United States
New England Med Ctr / Div of Geo Med & Infect Disease
Boston, Massachusetts, 02111, United States
Regions Hosp
Saint Paul, Minnesota, 55101, United States
Washington Univ
St Louis, Missouri, 63110, United States
Southwestern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103, United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Univ Hosps of Cleveland
Cleveland, Ohio, 44106, United States
MCP Hahnemann Univ
Philadelphia, Pennsylvania, 19102, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Amelia Ct Clinic
Dallas, Texas, 75235, United States
Joseph C Gathe
Houston, Texas, 77004, United States
San Juan VAMC
San Juan, 009265800, Puerto Rico