A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease
Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease
2 other identifiers
interventional
30
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Univ of Texas Med Branch
Galveston, Texas, 77555, United States
Univ of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
Calabrese LH, Lederman MM, Spritzler J, Coombs RW, Fox L, Schock B, Yen-Lieberman B, Johnson R, Mildvan D, Parekh N; AIDS Clinical Trials Group 334 Investigators. Placebo-controlled trial of cyclosporin-A in HIV-1 disease: implications for solid organ transplantation. J Acquir Immune Defic Syndr. 2002 Apr 1;29(4):356-62. doi: 10.1097/00126334-200204010-00005.
PMID: 11917239BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
L Calabrese
- STUDY CHAIR
M Lederman
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 2000
Last Updated
October 28, 2021
Record last verified: 2021-10