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

NCT00004276 | Completed Phase 2

• 2 other identifiers: 199/11682RU-0300395
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV Infections; Mycobacterium Infections; Tuberculosis

Keywords

bacterial infection; human immunodeficiency virus infection; immunologic disorders and infectious disorders; mycobacterium infection; mycobacterium tuberculosis infection; rare disease; viral infection

Interventions

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Rockefeller University: collaborator

Related Publications (5)

• Haslett P, Tramontana J, Burroughs M, Hempstead M, Kaplan G. Adverse reactions to thalidomide in patients infected with human immunodeficiency virus. Clin Infect Dis. 1997 Jun;24(6):1223-7. doi: 10.1086/513665.

  PMID: 9195087 BACKGROUND

• Tramontana JM, Utaipat U, Molloy A, Akarasewi P, Burroughs M, Makonkawkeyoon S, Johnson B, Klausner JD, Rom W, Kaplan G. Thalidomide treatment reduces tumor necrosis factor alpha production and enhances weight gain in patients with pulmonary tuberculosis. Mol Med. 1995 May;1(4):384-97.

  PMID: 8521296 BACKGROUND

• Haslett P, Hempstead M, Seidman C, Diakun J, Vasquez D, Freedman VH, Kaplan G. The metabolic and immunologic effects of short-term thalidomide treatment of patients infected with the human immunodeficiency virus. AIDS Res Hum Retroviruses. 1997 Aug 10;13(12):1047-54. doi: 10.1089/aid.1997.13.1047.

  PMID: 9264292 BACKGROUND

• Bekker LG, Haslett P, Maartens G, Steyn L, Kaplan G. Thalidomide-induced antigen-specific immune stimulation in patients with human immunodeficiency virus type 1 and tuberculosis. J Infect Dis. 2000 Mar;181(3):954-65. doi: 10.1086/315328.

  PMID: 10720518 BACKGROUND

• Klausner JD, Makonkawkeyoon S, Akarasewi P, Nakata K, Kasinrerk W, Corral L, Dewar RL, Lane HC, Freedman VH, Kaplan G. The effect of thalidomide on the pathogenesis of human immunodeficiency virus type 1 and M. tuberculosis infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Mar 1;11(3):247-57. doi: 10.1097/00042560-199603010-00005.

  PMID: 8603261 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Mycobacterium Infections; Tuberculosis; Bacterial Infections; Acquired Immunodeficiency Syndrome; Immune System Diseases; Communicable Diseases; Rare Diseases; Virus Diseases

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Slow Virus Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gilla Kaplan

  Rockefeller University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: September 1, 1990
• Study Completion: June 1, 1999
• Last Updated: June 24, 2005

Record last verified: 2001-12