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

Tracking Information
First Submitted Date ICMJE	November 2, 1999
First Posted Date ICMJE	August 31, 2001
Last Update Posted Date	February 16, 2012
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00000880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease
Official Title ICMJE	Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease
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: Zidovudine (ZDV) plus lamivudine (3TC); ZDV plus didanosine (ddI); Stavudine (d4T) plus 3TC; d4T plus ddI.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	HIV Infections
Intervention ICMJE	Drug: Cyclosporine
Study Arms	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	30
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	May 2000
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00000880
Other Study ID Numbers ICMJE	ACTG 334; 11306 ( Registry Identifier: DAIDS ES )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: L Calabrese Study Chair: M Lederman
PRS Account	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	February 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP