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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Adjuvants, Immunologic, Thalidomide, Cytokines, Viral Load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ochsner Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT00002174
Brief Title
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
Official Title
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Adjuvants, Immunologic, Thalidomide, Cytokines, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70102
Country
United States

12. IPD Sharing Statement

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

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