drugset / Trial / NCT00004276
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
Phase 2
Completed
50 enrolled
National Center for Research Resources (NCRR)
National Institute of Allergy and Infectious Diseases (NIAID) · collabRockefeller University · collab
RandomizedDouble-blindTreatment
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.
Timeline
- Start
- 1990-09
- Primary completion
- —
- Completion
- 1999-06
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thalidomide | Other / unclassified | — | Oral |