Increasing HAART-Induced Immune Restoration With Cyclosporine

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00031070

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Expected to finish

2006-12-01

Last updated by the study team

2015-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• University of California , Davis Medical Center — Sacramento, California, United States
• University of Miami — Miami, Florida, United States
• Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• University of Maryland, Institute of Human Virology — Baltimore, Maryland, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Washington Univ (St. Louis) — St Louis, Missouri, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Univ of North Carolina / Infectious Disease Division — Chapel Hill, North Carolina, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• MetroHealth Med Ctr — Cleveland, Ohio, United States
• University of Pennsylvania, Philadelphia — Philadelphia, Pennsylvania, United States
• Univ of Texas Southwestern Med Ctr — Dallas, Texas, United States
• Univ of Texas, Southwestern Med Ctr of Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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