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Using the Drug Thalidomide to Stimulate T Cells in HIV Positive Patients



Using the Drug Thalidomide to Stimulate T Cells in HIV Positive Patients

For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Despite treatment with anti-HIV drugs, people infected with HIV continue to have problems with their immune systems. This study will evaluate whether the drug thalidomide, which stimulates the immune system's T cells, can improve immune system function in people with HIV.
Details: In patients with chronic HIV infection, HIV replication and abnormalities in immune function persist following treatment with highly active antiretroviral therapy (HAART). Specifically, costimulatory T cell interactions are impaired. The immune modulatory drug thalidomide was recently found to costimulate T cells. Pharmacologic T cell costimulation may compensate for the T cell deficiencies in people with HIV disease and improve immune function. This study will test whether thalidomide treatment enhances HIV and cytomegalovirus (CMV)-specific immunity in patients with HIV and CMV, and will evaluate the effect of thalidomide on HIV replication. In this study, 40 HIV and CMV infected patients on HAART and 40 HIV uninfected CMV seropositive controls will be randomly assigned to low dose thalidomide or placebo treatment for 28 days. T cell responses and HIV replication and genetic diversification will be assessed.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV positive for at least 5 years prior to study entry - CD4 count of 300/mm3 or above - Pre-HAART nadir CD4 count <= 300/mm3 - CMV infection - HAART for 12 months prior to study entry - Same effective HAART regimen for 3 months prior to study entry - HIV < 200 copies/ml - Clinically stable Exclusion Criteria - Active opportunistic infection - Females of childbearing potential
Total Enrollment: 40

Location and Contact Information:

University of Miami School of Medicine *Recruiting*
Miami,  Florida,  33125
United States
Recruiting Michael  Picou 305-324-4455


Additional Information:
Study ID Numbers:  1R01AI47742-01A1;  7R01AI047742-02
Study Start Date: April 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053430

Other Hiv Infections Studies:
1. A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years

2. Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection

3. A Phase I Study of the Safety and Immunogenicity of rgp 120/HIV-1IIIB Vaccine in HIV-1 Seropositive Adult Volunteers

4. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Cannot Use Ganciclovir

5. A Comparison of 141W94 and Indinavir in HIV-Infected Patients

Related Studies:

Other HIV Infections Clinical Trials
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