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Sponsored by: |
Rockefeller University |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002392 |
To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients; particularly, on markers of immune activation and parameters of specific, anti-HIV cellular immunity.
Condition | Intervention |
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HIV Infections |
Drug: Thalidomide |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control, Efficacy Study |
Official Title: | A Study to Investigate the Potential of Thalidomide Treatment to Enhance Immune Responses in HIV-Infected Individuals Who Are Receiving Highly Active Antiretroviral Therapy. |
Estimated Enrollment: | 12 |
Patients receive oral thalidomide in a blinded, placebo-controlled study. [AS PER AMENDMENT 11/25/98: This is a double-blind, placebo-controlled trial in which thalidomide or placebo is administered for 21 days. After the first week of therapy, patients receive immunizations with keyhole limpet hemocyanin and polyvalent pneumococcal vaccine. Study therapy is stopped for 2 weeks after the immunizations. Following the immunizations, detailed evaluations of the immune responses to the vaccines are conducted over the next 8 weeks.]
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
PER AMENDMENT 11/25/98:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of serious hypersensitivity to tetanus toxoid or any of the vaccine components.
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Active drug or alcohol abuse.
Required:
Effective combination antiretroviral therapy including two nucleoside analog agents (ZDV, 3TC, ddI, ddC, or d4T) and nelfinavir or indinavir, for at least one month prior to study entry. [AS PER AMENDMENT 11/25/98:
Study ID Numbers: | 279A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002392 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lymphocyte Transformation Immunity, Cellular Drug Therapy, Combination Adjuvants, Immunologic Thalidomide |
Immunologic Memory Streptococcus pneumoniae Tetanus Toxoid Pneumococcal Vaccines |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Thalidomide Immunologic Factors Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Tetanus Angiogenesis Inhibitors |
Immunosuppressive Agents Immunologic Deficiency Syndromes Virus Diseases Anti-Bacterial Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections Pneumonia |
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 |