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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Thalidomide placebo; Drug: Thalidomide

Study type: Interventional

Funder types: NIH

Identifiers

NCT00053430

1R01AI047742-01A1

7R01AI047742-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Participants will receive low dose thalidomide for 28 days

Treatment:

Drug: Thalidomide

2

Placebo Comparator group

Description:

Participants will receive low dose thalidomide placebo for 28 days

Treatment:

Drug: Thalidomide placebo