Safety and Effectiveness of PEG-Intron in HIV-Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00005012

Run by

Schering-Plough

People needed

250

Starts

2000-03-01

Expected to finish

2000-09-01

Last updated by the study team

2005-06-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Duval County Health Department — Jacksonville, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Infectious Diseases Associates — Sarasota, Florida, United States
• Piedmont Physicians at Vinings — Atlanta, Georgia, United States
• TRIAD Health Practice — Chicago, Illinois, United States
• Univ of Maryland Institute of Human Virology — Baltimore, Maryland, United States
• New England Med Ctr / Div of Geo Med & Infect Disease — Boston, Massachusetts, United States
• Regions Hosp — Saint Paul, Minnesota, United States
• Washington Univ — St Louis, Missouri, United States
• Southwestern New Jersey AIDS Clinical Trials — Camden, New Jersey, United States
• East Orange Veterans Administration Med Ctr — East Orange, New Jersey, United States
• Beth Israel Med Ctr — New York, New York, United States
• Univ Hosps of Cleveland — Cleveland, Ohio, United States
• MCP Hahnemann Univ — Philadelphia, Pennsylvania, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Amelia Ct Clinic — Dallas, Texas, United States
• Joseph C Gathe — Houston, Texas, United States
• San Juan VAMC — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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