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A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease. Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease. Clinical research trials and A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease. health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease.. A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease. Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease. clinical trial. Human subjects frequently get the finest healthcare available for their A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease. condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease.  A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease.
A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease.
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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: 1. Zidovudine (ZDV) plus lamivudine (3TC) 2. ZDV plus didanosine (ddI) 3. Stavudine (d4T) plus 3TC 4. d4T plus ddI.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have a CD4 count greater than or equal to 500/mm3. - Have a plasma HIV RNA level greater than 600 copies/ml. - Are over 18 years of age. - Agree to practice abstinence or use barrier methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: - Have a history of an AIDS-defining illness, autoimmune disease, or hypertension. - Have renal disease. - Have any active infection other than HIV. - Have used certain antiretroviral medications. - Are pregnant.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
LCalabrese, Study Chair,
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Washington
Seattle, Washington, 98104
United States
Univ of Texas Med Branch
Galveston, Texas, 77555
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: ACTG 334;
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000880
Other Hiv Infections Studies:
1. Treatment Program for Anemia in AIDS Patients
2. Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
3. Kidney Transplants in People with HIV Infection
4. A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients with Acquired Immunodeficiency Related Diarrhea who were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
5. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
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A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease.
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