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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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Louisiana State University ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 20

Location and Contact Information:

Ochsner Clinic
New Orleans,  Louisiana,  70102
United States
 


Additional Information:
Study ID Numbers:
  262A; 
Study Start Date: 
Record last reviewed: July 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002174

Other Hiv Infections Studies:
1. A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy

2. Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

3. A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma

4. Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex

5. Evaluation of Specific Infection-Fighting Cells For Prediction of Immune Response to Anti-HIV and Immune-Boosting Medication

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Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients

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