Status:
COMPLETED
A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients With CD4 Cell Counts Less Than 50 Cells/mm3 or 300-500 Cells/mm3
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3. This study will look...
Detailed Description
IL-12 has a number of effects in vitro that could be relevant to HIV disease including promotion of TH1 cell development, enhancement of HIV-specific T cell responses in cells from subjects with AIDS,...
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Are 18-60 years old.
- Have a CD4 count less than 50 cells/mm3 or between 300-500 cells/mm3 within 30 days of study entry.
- Are expected to live at least 12 weeks.
- Agree to practice abstinence or use effective methods of birth control during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of cytomegalovirus (CMV) end-organ disease.
- Have a history of invasive fungal disease, unless the condition has been stable for 2 months.
- Have a history of severe allergic reactions to IL-2 or IL-12.
- Have a history of heart problems, autoimmune or rheumatologic disease, gastrointestinal bleeding, or any condition that would keep you from completing the study.
- Have MAC-related symptoms (fever, weight loss, frequent diarrhea) for at least 2 months prior to study entry.
- Are enrolled in another experimental research treatment study.
- Abuse alcohol or drugs.
- Are pregnant or breast-feeding.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 2001
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00000857
End Date
June 1 2001
Last Update
October 29 2021
Active Locations (16)
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1
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
2
USC CRS
Los Angeles, California, United States
3
Stanford CRS
Palo Alto, California, United States
4
Ucsf Aids Crs
San Francisco, California, United States