Placebo-controlled trial of cyclosporin-A in HIV-1 disease: implications for solid organ transplantation.
Leonard H Calabrese, Michael M Lederman, John Spritzler...
https://pubmed.ncbi.nlm.nih.gov/11917239Completed
Phase 2
Age: 18Years +
All Genders
ID00000880
Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
30
Participants Needed
12
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 safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system. Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection. CsA is capable of decreasing T cell activation, which in turn may decrease HIV replication.
CONDITIONS
Official Title
A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 count greater than or equal to 500/mm3.
- Have a plasma HIV RNA level greater than 600 copies/ml.
- Are over 18 years of age.
- Agree to practice abstinence or use barrier methods of birth control during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of an AIDS-defining illness, autoimmune disease, or hypertension.
- Have renal disease.
- Have any active infection other than HIV.
- Have used certain antiretroviral medications.
- Are pregnant.
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: 12 locations
1
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
2
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
3
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
4
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
5
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
6
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
7
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
8
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
9
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
10
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
11
Univ of Texas Med Branch
Galveston, Texas, United States, 77555
Status Unknown
12
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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