Increasing HAART-Induced Immune Restoration With Cyclosporine

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Cyclosporine; Cyclosporins; Efavirenz; Heptavalent Pneumococcal Conjugate Vaccine; Lamivudine; Lamivudine, zidovudine drug combination; Vaccines; Zidovudine

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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).