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| Sponsor: | Louisiana State University |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002174 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Thalidomide |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients |
| Estimated Enrollment: | 20 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions or symptoms are excluded:
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.
Contacts and Locations More Information
| Study ID Numbers: | 262A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002174 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Adjuvants, Immunologic Thalidomide Cytokines Viral Load |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Infection Anti-Bacterial Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Retroviridae Infections |
RNA Virus Infections Immune System Diseases Growth Substances Acquired Immunodeficiency Syndrome Immunosuppressive Agents Angiogenesis Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Leprostatic Agents |
