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Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
This study has been completed.
Study NCT00002174   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002174 on ClinicalTrials.gov Archive Site
 
 
 
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients

To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha, MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and alters viral load.

Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will include patients who have decided not to take anti-retro viral drugs. Groups III and IV will include patients receiving the same types of antiretroviral drugs. Patients in groups I and III will receive thalidomide while patients in group II and IV will receive placebo. The placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4, 5 and 6.

 
Interventional
Treatment, Double-Blind
HIV Infections
Drug: Thalidomide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
 
 

Inclusion Criteria

Patients must have:

  • HIV infection.
  • CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood.
  • Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

  • Fertile females.
  • Patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer.

Patients with any of the following prior conditions are excluded:

HIV related pre-existing peripheral neuropathy.

Prior Medication:

Excluded:

Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide.

Required:

10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002174
 
262A
Louisiana State University
 
 
NIH AIDS Clinical Trials Information Service
July 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP