Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000880 |
The purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system.
Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection. CsA is capable of decreasing T cell activation, which in turn may decrease HIV replication.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Cyclosporine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease |
Estimated Enrollment: | 30 |
There is increasing data on the potential for inhibition of immune activation as primary therapy for HIV infection. The rationale of CsA therapy is to decrease T cell activation in patients with early HIV infection. Activation of T cells leads to translation and transcription of provirus, release of viral progeny, and ultimately cell death. T cell activation also leads to increased cell death via apoptosis. CsA is capable of inhibiting both these events and thus may lead to decreased CD4 cell turnover.
This study has 2 arms of 15 patients each. Patients in Arm I receive placebo. Patients in Arm II receive CsA. Each arm is further divided into 2 strata. Stratum 1 patients are not allowed to receive antiretroviral therapy. Stratum 2 patients must receive 1 of the following 4 stable nucleoside analogue combinations:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
Univ of Texas Med Branch | |
Galveston, Texas, United States, 77555 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | L Calabrese | |
Study Chair: | M Lederman |
Study ID Numbers: | ACTG 334 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000880 |
Health Authority: | United States: Federal Government |
T-Lymphocytes Lymphocyte Transformation HIV-1 Drug Therapy, Combination |
Immunosuppressive Agents Apoptosis Cyclosporine Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral Cyclosporine Clotrimazole HIV Infections Miconazole |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Tioconazole Cyclosporins Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors |
Infection Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Antifungal Agents Lentivirus Infections Antirheumatic Agents Dermatologic Agents |