Increasing HAART-Induced Immune Restoration With Cyclosporine
Augmenting the Magnitude of HAART-Induced Immune Restoration With the Use of Cyclosporine
4 other identifiers
interventional
40
1 country
15
Brief Summary
The purpose of this study is to see if cyclosporine, taken when a patient begins highly active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that fight infection) in a patient's blood. This study also will explore the safety of briefly giving cyclosporine to patients starting HAART.
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
15 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
February 20, 2002
CompletedFirst Posted
Study publicly available on registry
February 22, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 9, 2015
August 1, 2006
February 20, 2002
March 5, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV infected.
- Have received no more than 7 days of any anti-HIV treatment prior to study entry and not within 3 weeks of study entry.
- Have a CD4 cell count greater than 100 cells/mm3 within 30 days prior to study entry.
- Have a viral load greater than 5000 copies/ml within 30 days prior to study entry.
- Agree not to become pregnant or to impregnate during the study. The female/male partners must use 2 acceptable methods of contraception while receiving drugs and for 6 weeks after stopping the study drugs. Women and men who cannot have children do not need to use contraception.
You may not qualify if:
- Patients may not be eligible for this study if they:
- Have an AIDS-related infection or abnormal tissue growth within 1 year of study entry.
- Are pregnant or breast-feeding.
- Weigh less than 88 lbs (40 kg).
- Have taken 3TC or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
- Have continuously taken for longer than 3 days any of the following prohibited drugs within 14 days before study entry: angiotensin-converting inhibitors, antibiotics, anticonvulsants, antihistamines, antineoplastics, antifungals, anti-inflammatory drugs, benzodiazepines, calcium channel blockers, gastrointestinal agents, systemic glucocorticoids, immunosuppressives, immunomodulators, potassium-sparing diuretics, statins, allopurinol, amiodarone, bromocryptine, danazol, digoxin, methotrexate, metoclopramide, octreotide, ticlopidine, orlistat, pimozide, nefazodone, fluvoxamine, and ergot derivatives.
- Have taken St. John's wort, grapefruit, or grapefruit juice continuously for longer than 3 days within 14 days before study entry.
- Are allergic or sensitive to study HAART or cyclosporine.
- Abuse drugs or alcohol.
- Have autoimmune disease requiring immunosuppression.
- Have kidney disease or insufficiency.
- Have uncontrolled hypertension.
- Have migraines that require current continuous use of drugs.
- Have a seizure disorder that requires continuous use of anti-seizure drugs.
- Have an HLA B-57 haplotype (this gene has been associated with an increased chance for developing an allergic reaction to ABC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of California , Davis Medical Center
Sacramento, California, 95814, United States
University of Miami
Miami, Florida, 33136-1013, United States
Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, 606123832, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana University Hospital
Indianapolis, Indiana, 46202-5250, United States
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392, United States
Washington Univ (St. Louis)
St Louis, Missouri, 63108, United States
Univ of North Carolina
Chapel Hill, North Carolina, 27599-7215, United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Related Publications (1)
Lederman MM, Smeaton L, Smith KY, Rodriguez B, Pu M, Wang H, Sevin A, Tebas P, Sieg SF, Medvik K, Margolis DM, Pollard R, Ertl HC, Valdez H. Cyclosporin A provides no sustained immunologic benefit to persons with chronic HIV-1 infection starting suppressive antiretroviral therapy: results of a randomized, controlled trial of the AIDS Clinical Trials Group A5138. J Infect Dis. 2006 Dec 15;194(12):1677-85. doi: 10.1086/509261. Epub 2006 Nov 2.
PMID: 17109339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Lederman, M.D.
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 20, 2002
First Posted
February 22, 2002
Study Completion
December 1, 2006
Last Updated
March 9, 2015
Record last verified: 2006-08