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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00084149 |
Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in transplant patients who receive donor organs. CsA may also help people with HIV. The purpose of this study is to determine the safety of and immune response to CsA when given with abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/AZT) and lopinavir/ritonavir (LPV/r) to HIV infected adults in the early stages of infection.
Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to acute infected individuals treated with LPV/r alone.
Condition | Intervention | Phase |
HIV Infections |
Drug: Abacavir sulfate, Lamivudine, and Zidovudine Drug: Lopinavir/Ritonavir |
Phase II |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Zidovudine Abacavir Abacavir sulfate Lamivudine Cyclosporine Cyclosporin Ritonavir Lopinavir Trizivir |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Study of the Safety, Immunologic, and Virologic Effects of Cyclosporine A in Conjunction With Trizivir(R) and Kaletra(R) Versus Trizivir(R) and Kaletra(R) Alone During Primary HIV-1 Infection |
Estimated Enrollment: | 50 |
During the early stages of HIV infection, HIV replicates unchecked, massive numbers of CD4 T cells are infected and destroyed, and other CD4 cells become infected but enter a latent phase. This latent pool of infected CD4 cells poses a difficult challenge in eliminating HIV infection during the early stages of infection because the cells persist for long periods, even with highly active effective antiretroviral therapy, and may later become active.
CsA is popularly used as a lifelong immunosuppressant for organ transplant patients. CsA inhibits cellular activation, including CD4 cell activation and proliferation. By reducing CD4 cell activation during acute HIV infection, fewer CD4 cells may be infected and die; more importantly, there may be fewer latent cells with the potential to become active later in the disease. However, CsA has many potential toxic effects, including renal damage, and may affect neurologic, endocrine, and hepatic organ systems.
In a previous small study of adults with acute HIV infection, a short 8-week course of CsA was well tolerated, and it is thought that a 4-week course of CsA may result in substantial reduction in both viral load and T cell activation, outweighing any potential toxic effects sustained during the one month treatment. This study will evaluate the safety of and immune response to a 4-week course of CsA with ABC/3TC/AZT and LPV/r compared to ABC/3TC/AZT and LPV/r alone in patients with acute HIV infection.
This 48-week study will randomly assign patients to one of two arms. During the first 4 weeks of the study, Arm A will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r. Arm B will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks. On a case-by-case basis, an investigator may wish to prescribe ABC/3TC rather than ABC/3TC/AZT at initial therapy. Participants with ABC hypersensitivity will be given 3TC/AZT instead of ABC/3TC/AZT.
A complete physical exam and medical history assessment will occur at study entry and at Week 48. Study visits will occur every week until Week 4, then every 4 weeks until the end of the study. Blood and urine collection and clinical assessments will occur at each study visit. Additionally, patients in Arm A only will undergo CsA level monitoring at Day 3 and Weeks 1, 2, and 3; CsA dosage may be adjusted as necessary.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |||||
University of Alabama-Birmingham | |||||
Birmingham, Alabama, United States, 35294-2050 | |||||
United States, California | |||||
University of California-San Diego | |||||
San Diego, California, United States, 92103 | |||||
San Francisco General Hospital | |||||
San Francisco, California, United States, 94110 | |||||
University of California-San Francisco | |||||
San Francisco, California, United States, 94110 | |||||
Harbor-UCLA | |||||
Culver City, California, United States, 90230 | |||||
Cedars-Sinai Medical Center | |||||
Culver City, California, United States, 90230 | |||||
United States, Florida | |||||
University of Miami | |||||
Miami, Florida, United States, 33136-1013 | |||||
United States, Minnesota | |||||
University of Minnesota | |||||
Minneapolis, Minnesota, United States, 55455-0392 | |||||
United States, New York | |||||
Aaron Diamond AIDS Research Center at Rockefeller | |||||
New York, New York, United States, 10021 | |||||
Beth Israel Medical Center | |||||
New York, New York, United States, 10003 | |||||
NYU/Bellevue | |||||
New York, New York, United States, 10016-6481 | |||||
SUNY-Downstate Medical Center | |||||
Brooklyn, New York, United States, 11023 | |||||
Columbia University | |||||
New York, New York, United States, 10032 | |||||
United States, Ohio | |||||
Case Western Reserve University | |||||
Cleveland, Ohio, United States, 44106-5083 | |||||
University of Cincinnati | |||||
Cincinnati, Ohio, United States, 45267-0405 | |||||
MetroHealth Medical Center | |||||
Cleveland, Ohio, United States, 44109-1998 |
Study Chair: | Martin Markowitz, MD | Aaron Diamond AIDS Research Center |
Study Chair: | Susan Little, MD | Department of Medicine, University of California at San Diego |
Study ID Numbers: | AIEDRP AIN501/ACTG A5216, AIEDRP AIN501, ACTG A5216 |
First Received: | June 7, 2004 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00084149 |
Health Authority: | United States: Food and Drug Administration |
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