A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease

NCT ID: NCT00000880

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2000-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

HIV Infections

Keywords

T-Lymphocytes; Lymphocyte Transformation; HIV-1; Drug Therapy, Combination; Immunosuppressive Agents; Apoptosis; Cyclosporine; Anti-HIV Agents

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Cyclosporine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

L Calabrese

Role: STUDY_CHAIR

M Lederman

Role: STUDY_CHAIR

Locations

San Francisco Gen Hosp

San Francisco, California, United States

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Northwestern Univ Med School

Chicago, Illinois, United States

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Johns Hopkins Hosp

Baltimore, Maryland, United States

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

Beth Israel Med Ctr

New York, New York, United States

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Univ of North Carolina

Chapel Hill, North Carolina, United States

Case Western Reserve Univ

Cleveland, Ohio, United States

Univ of Texas Med Branch

Galveston, Texas, United States

Univ of Washington

Seattle, Washington, United States

Countries

United States

References

Calabrese LH, Lederman MM, Spritzler J, Coombs RW, Fox L, Schock B, Yen-Lieberman B, Johnson R, Mildvan D, Parekh N; AIDS Clinical Trials Group 334 Investigators. Placebo-controlled trial of cyclosporin-A in HIV-1 disease: implications for solid organ transplantation. J Acquir Immune Defic Syndr. 2002 Apr 1;29(4):356-62. doi: 10.1097/00126334-200204010-00005.

Reference Type: BACKGROUND

PMID: 11917239 (View on PubMed)

Other Identifiers

11306

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 334

Identifier Type: -

Identifier Source: org_study_id