Using the Drug Thalidomide to Stimulate T Cells in HIV-Infected People

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Thalidomide placebo; Drug: Thalidomide

• Registration Number: NCT00053430
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2003-01-29
• Study First Submitted QC: 2003-01-29
• Study First Posted: 2003-01-30
• Primary Completion: 2005-08
• Study Completion: 2006-02
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Thalidomide placebo	Participants will receive low dose thalidomide placebo for 28 days
1	Thalidomide	Participants will receive low dose thalidomide for 28 days

Primary Outcome Measures

Name	Time	Method
Doubling in HIV Pol-specific CD8 cells, measured by ELISPOT	Through Day 28
Increase in CMV pp65 CD8 cells, measured by ELISPOT in the thalidomide treatment group	Throughout study
Increase in HIV p24-specific IFN-gamma-secreting CD4 cells in the thalidomide treatment group, measured by fluorescence-activated cell sorting (FACS)	Throughout study
Increase in cytomegalovirus (CMV)-specific interferon (IFN)-gamma-secreting CD4 T cells in the thalidomide treatment group, measured by FACS	Throughout study

Secondary Outcome Measures

Name	Time	Method
Increase in the frequency of keyhole limpet hemocyanin (KLH)-specific lymphocyte proliferative responses in the thalidomide treatment group	Throughout study
Increase in adverse events in the thalidomide treatment group	Throughout study

Trial Locations

Locations (1)

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States