A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease
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| First Received Date ICMJE | November 2, 1999 | ||||||||
| Last Updated Date | February 14, 2012 | ||||||||
| 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. |
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| 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:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||||||
| Condition ICMJE | HIV Infections | ||||||||
| Intervention ICMJE | Drug: Cyclosporine | ||||||||
| Study Arm (s) | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 30 | ||||||||
| Completion Date | May 2000 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria You may be eligible for this study if you:
Exclusion Criteria You will not be eligible for this study if you:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| 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 | ||||||||
| Has Data Monitoring Committee | 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 |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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