A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection

NCT00000812 | Completed Phase 1

• 3 other identifiers: ACTG 26742,24011243
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Thalidomide

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• CNS active agents, such as alcohol, narcotics (i.e., morphine, codeine, meperidine), barbiturates, benzodiazepines, tricyclic antidepressants, phenothiazines, sedating antihistamines, or over-the-counter sleeping aids.
• Patients must have:
• HIV infection.
• CD4 count 200 - 500 cells/mm3.
• No active opportunistic infection requiring systemic therapy within the past 14 days.
• NOTE: Women must be post-menopausal or provide written documentation of surgical sterilization, and sexually active men must use a barrier method of contraception, beginning 4 weeks prior to study entry and continuing until 4 weeks following end of treatment.
• PER AMENDMENT 8/2/96:
• Been on stable licensed antiretroviral treatment for 60 days prior to study entry or must not have received any antiretroviral medications for 60 days prior to study entry.
• Prior Medication:
• Required:
• Patients must have been on stable licensed antiretroviral treatment for 60 days prior to study entry or must not have received any antiretroviral medications for 60 days prior to study entry.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Malignancy requiring chemotherapy.
• Grade 2 or worse peripheral neuropathy.
• Medical condition that would interfere with evaluation of patient.
• Concurrent Medication:
• Excluded in all patients:
• Didanosine ( ddI ).
• Zalcitabine ( ddC ).
• Stavudine ( d4T ).
• Other immunologically active agents.
• Systemic cytotoxic chemotherapy.
• Excluded in all patients unless taken only occasionally or unless medication could be stopped in the event of overlapping toxicity:
• CNS active agents, such as alcohol, narcotics (i.e., morphine, codeine, meperidine), barbiturates, benzodiazepines, tricyclic antidepressants, phenothiazines, sedating antihistamines, or over-the-counter sleeping aids.
• Patients with the following prior conditions are excluded:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Celgene Corporation: collaborator

Study Sites (6)

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

Memorial Sloan-Kettering Cancer Ctr.

New York, New York, 10021, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Wohl D, Pomerantz R, Schmitz J, Aweeka F, Fox L, Weng D, Spritzler J, Robinson W, Holohan M, Teppler H. Thalidomide pharmacokinetics (PK) safety and effect on HIV viral load and immune parameters. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 352)

  BACKGROUND

• Wohl DA, Aweeka FT, Schmitz J, Pomerantz R, Cherng DW, Spritzler J, Fox L, Simpson D, Bell D, Holohan MK, Thomas S, Robinson W, Kaplan G, Teppler H; National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group 267. Safety, tolerability, and pharmacokinetic effects of thalidomide in patients infected with human immunodeficiency virus: AIDS Clinical Trials Group 267. J Infect Dis. 2002 May 1;185(9):1359-63. doi: 10.1086/340133. Epub 2002 Apr 16.

  PMID: 12001058 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

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

• Teppler H

  STUDY CHAIR

• Pomerantz R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 2000
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (6)