A Phase I, placebo-controlled trial of multi-dose recombinant human interleukin-12 in patients with HIV infection.
Mark A Jacobson, John Spritzler, Alan Landay...
https://pubmed.ncbi.nlm.nih.gov/12004273Completed
Phase 1
Age: 18Years - 60Years
All Genders
ID00000857
A Phase I, Double-Blind, Randomized, Placebo-Controlled Trial of Recombinant Human Interleukin-12 (rhIL-12) in HIV-Infected Subjects With Less Than 50 CD4+ T Cells and Subjects With 300-500 CD4+ T Cells
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
65
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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 at the ability of rhIL-12 to boost the immune system against HIV and HIV-associated bacterial infections in these patients. IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection. IL-12 may also increase the body's ability to fight bacterial infections such as Mycobacterium avium complex (MAC).
CONDITIONS
Official Title
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
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 16 locations
1
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Status Unknown
2
USC CRS
Los Angeles, California, United States
Status Unknown
3
Stanford CRS
Palo Alto, California, United States
Status Unknown
4
Ucsf Aids Crs
San Francisco, California, United States
Status Unknown
5
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
Status Unknown
6
Northwestern University CRS
Chicago, Illinois, United States, 60611
Status Unknown
7
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
Status Unknown
8
Weiss Memorial Hosp.
Chicago, Illinois, United States, 60640
Status Unknown
9
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Status Unknown
10
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Status Unknown
11
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
Status Unknown
12
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Status Unknown
13
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Status Unknown
14
Unc Aids Crs
Chapel Hill, North Carolina, United States
Status Unknown
15
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
16
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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