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

Pharmacologic T Cell Costimulation In HIV Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00053430

Enrollment

Registered

2003-01-30

Start date

2001-04-30

Completion date

2006-02-28

Last updated

2009-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Immune Modulation, Thalidomide, Immune reconstitution, Treatment Experienced

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.

Interventions

DRUGThalidomide

Tablet taken orally daily

DRUGThalidomide placebo

Placebo tablet taken orally daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026