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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Participants will receive low dose thalidomide for 28 days

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

Tablet taken orally daily

2

Participants will receive low dose thalidomide placebo for 28 days

Group Type PLACEBO_COMPARATOR

Thalidomide placebo

Intervention Type DRUG

Placebo tablet taken orally daily

Interventions

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Thalidomide

Tablet taken orally daily

Intervention Type DRUG

Thalidomide placebo

Placebo tablet taken orally daily

Intervention Type DRUG

Eligibility Criteria

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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