A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART
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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 |
---|---|
HIV Infections |
Drug: Thalidomide |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
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:
- Documented HIV infection.
- CD4+ cell count between 300 and 500 cells/mm3.
- HIV-1 RNA < 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry [AS PER AMENDMENT 11/25/98:
- Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test].
- Established B cell lines [deleted AS PER AMENDMENT 11/25/98].
- Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses.
- Life expectancy > 6 months [deleted AS PER AMENDMENT 11/25/98].
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Active opportunistic infection or HIV-related malignancy [HIV-related malignancy deleted AS PER AMENDMENT 11/25/98].
- Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria.
Concurrent Medication:
Excluded:
- Other investigational HIV-drugs.
- Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline.
Patients with the following prior conditions are excluded:
History of serious hypersensitivity to tetanus toxoid or any of the vaccine components.
Prior Medication:
Excluded:
- Previous immunization with pneumococcal polysaccharide vaccine [or, AS PER AMENDMENT 11/25/98, keyhole limpet hemocyanin vaccine].
- Tetanus toxoid booster within 5 years [deleted AS PER AMENDMENT 11/25/98].
- Other investigational HIV-drugs within 6 weeks of enrollment.
- Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline within 6 weeks of enrollment.
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:
- On stable, effective, highly-active antiretroviral therapy with combinations of any FDA-approved anti-HIV drugs for at least 3 months prior to entry.]
No publications provided
ClinicalTrials.gov Identifier: | NCT00002392 History of Changes |
Other Study ID Numbers: | 279A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Lymphocyte Transformation Immunity, Cellular Drug Therapy, Combination Adjuvants, Immunologic Thalidomide |
Immunologic Memory Streptococcus pneumoniae Tetanus Toxoid Pneumococcal Vaccines |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Adjuvants, Immunologic Thalidomide |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on March 10, 2013