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A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART

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ClinicalTrials.gov Identifier: NCT00002392
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infections Drug: Thalidomide

Detailed Description:
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.]

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Thalidomide
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.]
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002392


Locations
United States, New York
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
More Information

ClinicalTrials.gov Identifier: NCT00002392     History of Changes
Other Study ID Numbers: 279A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1999

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents