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Home > "I" Clinical Trials Conditions > Increasing HAART-Induced Immune Restoration with Cyclosporine  Increasing HAART-Induced Immune Restoration with Cyclosporine
Increasing HAART-Induced Immune Restoration with Cyclosporine
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: The availability of HAART has substantially decreased the morbidity and mortality caused by HIV-1 infection. There is clinical and laboratory evidence suggesting that treatment of HIV-1 infection not only arrests the progressive immune deterioration caused by HIV-1, but also is associated with at least partial immune reconstitution. After starting HAART, most patients with chronic HIV-1 infection experience an increase in CD4 T-cells, but the magnitude of CD4 lymphocyte rise is highly variable. Patients who do not experience a substantial rise in circulating CD4 lymphocytes remain at risk for opportunistic infections. Strategies to enhance immune restoration in HIV-1 disease are needed. Studies have shown that immune restoration after HAART in patients with chronic HIV-1 infection is incomplete. There are, however, several potential methods that can be used that possibly may enhance the magnitude of CD4 lymphocyte rise induced by HAART. It is proposed that the lymphoid tissues, in which lymphocytes are trapped and activated to die, are a major site of immunopathology and cellular losses in HIV-infection. Interference with lymphocyte trapping and death in lymphoid tissues when cyclosporine, an immunosuppressant, is administered at the time of initiation of HAART may result in an enhancement of the magnitude of cellular restoration in patients who initiate HAART. Patients are randomized to 1 of 2 treatment arms: Arm A: Weeks 1 to 2: abacavir (ABC)/lamivudine (3TC)/zidovudine (ZDV). Weeks 3 to 48: ABC/3TC/ZDV and efavirenz (EFV). Arm B: Weeks 1 to 2: ABC/3TC/ZDV and cyclosporine. Weeks 3 to 48: ABC/3TC/ZDV and EFV. Patients in both arms receive the following immunizations: Weeks 8 and 12: Hepatitis A vaccine inactivated and rabies vaccine. Week 16: Rabies vaccine. To ascertain whether the augmentation in the rise in CD4 lymphocytes is sustained, the number of circulating CD4 lymphocytes 48 weeks after starting therapy is compared. To examine the functional significance of the cellular increases, the ability of patients to respond to immunization with recall and neoantigens are compared between the cyclosporine plus HAART arm and the HAART alone arm. Substudy A5139: A 2-week substudy designed to explore the mechanisms of first-phase cellular restoration is performed. Patients undergo 4 lymph node aspirates. Lymphocytes are analyzed by the use of flow cytometry and correlated with findings in the main study. There is no limit on patient enrollment. Patients register to the substudy immediately after randomizing to the main study.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
MichaelLederman, Study Chair, Case Western Reserve University
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
United States
University of Miami
Miami, Florida, 33136-1013
United States
Univ of North Carolina
Chapel Hill, North Carolina, 27599-7215
United States
Washington Univ (St. Louis)
St. Louis, Missouri, 63108
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
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Indiana University Hospital
Indianapolis, Indiana, 46202-5250
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
University of California , Davis Medical Center
Sacramento, California, 95814
United States
Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis
Chicago, Illinois, 606123832
United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390
United States
Additional Information:
Study ID Numbers: ACTG A5138; AACTG A5138,ACTG A5139s,AACTG A5139s
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031070
Other Hiv Infections Studies:
1. Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
2. Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
3. Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution
4. Carotid Artery Thickness in HIV Infected and Uninfected Adults
5. A Study of Lopinavir/Ritonavir in Infants with HIV
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Increasing HAART-Induced Immune Restoration with Cyclosporine
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