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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002392

Run by

Rockefeller University

People needed

12

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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].

You may not qualify if…

• 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.]

Where it is running

• Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ — New York, New York, United States

Full record on ClinicalTrials.gov

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