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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Celgene Corporation |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000812 |
PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral thalidomide.
SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and viral burden.
A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in patients with HIV infection and may cause the body to produce more virus. In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV. However, more information on the pharmacological and immunological aspects of thalidomide is needed.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Thalidomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
Official Title: | A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection |
Estimated Enrollment: | 36 |
A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in patients with HIV infection and may cause the body to produce more virus. In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV. However, more information on the pharmacological and immunological aspects of thalidomide is needed.
Patients are randomized to receive oral thalidomide or matching placebo (3:1) at one of three dose levels daily for 8 weeks. All 12 patients at a dose level must receive treatment for at least 2 weeks before dose escalation in subsequent patients occurs. The MTD is defined as the dose level immediately below that at which 3 or more of 9 patients receiving thalidomide experience dose-limiting toxicity. Patients are followed for a total of 16 weeks.
PER 6/20/95 AMENDMENT: Patients in cohort 1 should discontinue the previous 50 mg formulation of thalidomide once the new formulation is available. Those patients may either wash out for 4 weeks and recommence the study or discontinue the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed for occasional use (chronic use is permitted only if clinician deems that medication can be discontinued in the event of overlapping toxicity):
Patients must have:
PER AMENDMENT 8/2/96:
Prior Medication:
Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded in all patients:
Excluded in all patients unless taken only occasionally or unless medication could be stopped in the event of overlapping toxicity:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 14 days prior to study entry:
Excluded within 30 days prior to study entry:
PER AMENDMENT 8/2/96:
Excluded within 60 days prior to study entry:
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Univ of Pennsylvania at Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Thomas Jefferson Univ Hosp | |
Philadelphia, Pennsylvania, United States, 191075098 |
Study Chair: | Teppler H | |
Study Chair: | Pomerantz R |
Study ID Numbers: | ACTG 267, 42,240 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000812 |
Health Authority: | United States: Federal Government |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Thalidomide |
Virus Diseases Sexually Transmitted Diseases, Viral Thalidomide HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Infection |
Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Lentivirus Infections Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |