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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00053430 |
Despite treatment with anti-HIV drugs, people infected with HIV continue to have problems with their immune systems. This study will evaluate whether the drug thalidomide, which stimulates the immune system's T cells, can improve immune system function in people with HIV.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Thalidomide Drug: Thalidomide placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pharmacologic T Cell Costimulation In HIV Disease |
Enrollment: | 40 |
Study Start Date: | April 2001 |
Study Completion Date: | February 2006 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive low dose thalidomide for 28 days
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Drug: Thalidomide
Tablet taken orally daily
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2: Placebo Comparator
Participants will receive low dose thalidomide placebo for 28 days
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Drug: Thalidomide placebo
Placebo tablet taken orally daily
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In patients with chronic HIV infection, HIV replication and abnormalities in immune function persist following treatment with highly active antiretroviral therapy (HAART). Specifically, costimulatory T cell interactions are impaired. The immune modulatory drug thalidomide was recently found to costimulate T cells. Pharmacologic T cell costimulation may compensate for the T cell deficiencies in people with HIV disease and improve immune function. This study will test whether thalidomide treatment enhances HIV and cytomegalovirus (CMV)-specific immunity in patients with HIV and CMV, and will evaluate the effect of thalidomide on HIV replication.
In this study, 40 HIV and CMV infected patients on HAART and 40 HIV uninfected CMV seropositive controls will be randomly assigned to low dose thalidomide or placebo treatment for 28 days. T cell responses and HIV replication and genetic diversification will be assessed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
United States, Florida | |
University of Miami School of Medicine | |
Miami, Florida, United States, 33125 |
Principal Investigator: | Patrick Haslett, MD | Department of Microbiology and Immunology, University of Miami School of Medicine |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | 1R01AI47742-01A1, 7R01AI047742-02 |
Study First Received: | January 29, 2003 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00053430 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Immune Modulation Thalidomide Immune reconstitution Treatment Experienced |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Thalidomide Immunologic Factors Acquired Immunodeficiency Syndrome Immunosuppressive Agents Angiogenesis Inhibitors |
Immunologic Deficiency Syndromes Virus Diseases Anti-Bacterial Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Infection Anti-Bacterial Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Retroviridae Infections |
RNA Virus Infections Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Immunosuppressive Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Leprostatic Agents |