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

NCT00002392 | Completed

• 1 other identifier: 279A
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Lymphocyte Transformation; Immunity, Cellular; Drug Therapy, Combination; Adjuvants, Immunologic; Thalidomide; Immunologic Memory; Streptococcus pneumoniae; Tetanus Toxoid; Pneumococcal Vaccines

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

HIV Infections; Tetanus

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1999-04

Locations

US (1)