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A Study to Investigate the Potential of Thalidomide Treatment to Enhance Immune Responses in HIV-Infected Individuals Who Are Receiving Highly Active Antiretroviral Therapy.
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.
Patients receive oral thalidomide in a blinded, placebo-controlled study. \[AS PER AMENDMENT 11/25/98: This is a double-blind, placebo-controlled trial in which thalidomide or placebo is administered for 21 days. After the first week of therapy, patients receive immunizations with keyhole limpet hemocyanin and polyvalent pneumococcal vaccine. Study therapy is stopped for 2 weeks after the immunizations. Following the immunizations, detailed evaluations of the immune responses to the vaccines are conducted over the next 8 weeks.\]
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States
Last Updated
June 24, 2005
12
Estimated participants
Thalidomide
DRUG
Lead Sponsor
Rockefeller University
NCT04142047
NCT06694805
Data Source & Attribution
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