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CompletedNCT00002392Updated Jun 24, 2005

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

An interventional study of Thalidomide in HIV Infections, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Rockefeller University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.]

02

Conditions studied

  • HIV Infections

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Keywords

  • Lymphocyte Transformation
  • Immunity, Cellular
  • Drug Therapy, Combination
  • Adjuvants, Immunologic
  • Thalidomide
  • Immunologic Memory
  • Streptococcus pneumoniae
  • Tetanus Toxoid
  • Pneumococcal Vaccines
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 12 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Rockefeller University is the lead sponsor of 120 studies on the registry; 3 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.]
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Enrollment
12 participants

Interventions

  • DrugThalidomide
06

Study locations

1 site
  • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
    New York, New York 10021, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002392
Lead sponsor
Rockefeller University
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 1999. You cannot join it, but the record below documents what was studied.

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