Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections

OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy.

II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.

III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or mycobacterial infections.

Completed

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Rare Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type of infection.

Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Human immunodeficiency virus (HIV) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment

Mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for Mycobacterium tuberculosis

At least 1 of the following signs and symptoms required:

Temperature over 38 degrees C on at least 2 occasions within 1 week prior to treatment
Weight loss greater than 5 kg
Pulmonary involvement in at least 1 lobe on x-ray

Night sweats on at least 2 occasions within 1 week prior to treatment

--Prior/Concurrent Therapy--

Concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed

--Patient Characteristics--

No neuropathy and not at risk for neuropathy
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 weeks after study

Treatment and study plan

thalidomide

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Rockefeller University

Registry information

Important dates

Study start: 1990
Study completion: 1999
First posted: Oct 19, 1999
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed