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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002174
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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
Primary Purpose: Treatment
Official Title: Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 20
Detailed Description:
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002174


Locations
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70102
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
  More Information

ClinicalTrials.gov Identifier: NCT00002174     History of Changes
Other Study ID Numbers: 262A
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: July 1997

Keywords provided by NIH AIDS Clinical Trials Information Service:
Adjuvants, Immunologic
Thalidomide
Cytokines
Viral Load

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents