Safety and Effectiveness of PEG-Intron in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00005012
- Lead Sponsor
- Schering-Plough
- 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Univ of Maryland Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
MCP Hahnemann Univ
🇺🇸Philadelphia, Pennsylvania, United States
Piedmont Physicians at Vinings
🇺🇸Atlanta, Georgia, United States
TRIAD Health Practice
🇺🇸Chicago, Illinois, United States
Washington Univ
🇺🇸St. Louis, Missouri, United States
San Juan VAMC
🇵🇷San Juan, Puerto Rico
Amelia Ct Clinic
🇺🇸Dallas, Texas, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Univ Hosps of Cleveland
🇺🇸Cleveland, Ohio, United States
Joseph C Gathe
🇺🇸Houston, Texas, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Southwestern New Jersey AIDS Clinical Trials
🇺🇸Camden, New Jersey, United States
Regions Hosp
🇺🇸St. Paul, Minnesota, United States
Infectious Diseases Associates
🇺🇸Sarasota, Florida, United States
East Orange Veterans Administration Med Ctr
🇺🇸East Orange, New Jersey, United States
Duval County Health Department
🇺🇸Jacksonville, Florida, United States
New England Med Ctr / Div of Geo Med & Infect Disease
🇺🇸Boston, Massachusetts, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States