Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
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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: | Masking: Double-Blind Primary Purpose: Treatment |
| 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:
- 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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002174 History of Changes |
| Other Study ID Numbers: | 262A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Adjuvants, Immunologic Thalidomide Cytokines Viral Load |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Adjuvants, Immunologic Thalidomide |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013