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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000880

Collaborator

(none)

Enrollment

Locations

2.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Cyclosporine	Phase 2

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:

Zidovudine (ZDV) plus lamivudine (3TC)
ZDV plus didanosine (ddI)
Stavudine (d4T) plus 3TC
d4T plus ddI.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease

Actual Study Completion Date :

May 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Gen Hosp	San Francisco	California	United States	941102859
2	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
3	Northwestern Univ Med School	Chicago	Illinois	United States	60611
4	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
5	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
6	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts	United States	02114
7	Beth Israel Med Ctr	New York	New York	United States	10003
8	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
9	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
10	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
11	Univ of Texas Med Branch	Galveston	Texas	United States	77555
12	Univ of Washington	Seattle	Washington	United States	98104