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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00053430
First received: January 29, 2003
Last updated: August 6, 2009
Last verified: August 2009

January 29, 2003
August 6, 2009
April 2001
August 2005   (final data collection date for primary outcome measure)
  • Doubling in HIV Pol-specific CD8 cells, measured by ELISPOT [ Time Frame: Through Day 28 ] [ Designated as safety issue: No ]
  • Increase in CMV pp65 CD8 cells, measured by ELISPOT in the thalidomide treatment group [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Increase in HIV p24-specific IFN-gamma-secreting CD4 cells in the thalidomide treatment group, measured by fluorescence-activated cell sorting (FACS) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Increase in cytomegalovirus (CMV)-specific interferon (IFN)-gamma-secreting CD4 T cells in the thalidomide treatment group, measured by FACS [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00053430 on ClinicalTrials.gov Archive Site
  • Increase in the frequency of keyhole limpet hemocyanin (KLH)-specific lymphocyte proliferative responses in the thalidomide treatment group [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Increase in adverse events in the thalidomide treatment group [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Using the Drug Thalidomide to Stimulate T Cells in HIV-Infected People
Pharmacologic T Cell Costimulation In HIV Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
HIV Infections
  • Drug: Thalidomide
    Tablet taken orally daily
  • Drug: Thalidomide placebo
    Placebo tablet taken orally daily
  • Experimental: 1
    Participants will receive low dose thalidomide for 28 days
    Intervention: Drug: Thalidomide
  • Placebo Comparator: 2
    Participants will receive low dose thalidomide placebo for 28 days
    Intervention: Drug: Thalidomide placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2006
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria

  • HIV-infected for at least 5 years prior to study entry
  • CD4 count of 300/mm3 or above
  • Pre-HAART nadir CD4 count of 300/mm3 or less
  • CMV infection
  • HAART for 12 months prior to study entry
  • Same effective HAART regimen for 3 months prior to study entry
  • HIV viral load less than 200 copies/ml
  • Clinically stable

Exclusion Criteria

  • Active opportunistic infection
  • Females of childbearing potential
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053430
1R01AI47742-01A1, 7R01AI047742-02
Not Provided
Rona Siskind, DAIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Patrick Haslett, MD Department of Microbiology and Immunology, University of Miami School of Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP