Completed

Thalidomide for Enhanced Immune Responses in HIV-Infected Individuals on Antiretroviral Therapy

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What is being tested

Thalidomide

Drug
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorRockefeller University
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.]

NCT00002392
Principal SponsorRockefeller University
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesBacterial InfectionsClostridium InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsTetanusHIV Infections

Criteria

7 inclusion criteria required to participate
CD4+ cell count between 300 and 500 cells/mm3.
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.
Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses.
Documented HIV infection.
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9 exclusion criteria prevent from participating
History of serious hypersensitivity to tetanus toxoid or any of the vaccine components.
Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline.
Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria.
Previous immunization with pneumococcal polysaccharide vaccine or keyhole limpet hemocyanin vaccine.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

New York, United StatesOpen Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ in Google Maps
CompletedOne Study Center