Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers

NCT00000690 | Completed Phase 1

• 2 other identifiers: ACTG 07811053
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation. DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.

Conditions

HIV Infections

Keywords

Reference Values; Infusions, Intravenous; Intestinal Absorption; Dextran Sulfate; Administration, Oral; Blood Coagulation

Interventions

Dextran sulfate DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Co-existing Condition:
• Volunteers with any of the following are excluded:
• Disorders of coagulation or disorders of plasma lipids.
• Allergy to dextran sulfate, other sulfates, other dextrans.
• Concurrent Medication:
• Excluded:
• Volunteers who anticipate need for medication during study.
• Volunteers with any of the following are excluded:
• Disorders of coagulation or disorders of plasma lipids.
• Allergy to dextran sulfate, other sulfates, other dextrans.
• Prior Medication:
• Excluded within 2 weeks of study entry:
• Any medication.
• Risk Behavior:
• Excluded:

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• Flexner C, Barditch-Crovo PA, Kornhauser DM, Farzadegan H, Nerhood LJ, Chaisson RE, Bell KM, Lorentsen KJ, Hendrix CW, Petty BG, et al. Pharmacokinetics, toxicity, and activity of intravenous dextran sulfate in human immunodeficiency virus infection. Antimicrob Agents Chemother. 1991 Dec;35(12):2544-50. doi: 10.1128/AAC.35.12.2544.

  PMID: 1810188 BACKGROUND

• Hiebert LM, Wice SM, Jaques LB, Williams KE, Conly JM. Orally administered dextran sulfate is absorbed in HIV-positive individuals. J Lab Clin Med. 1999 Feb;133(2):161-70. doi: 10.1016/s0022-2143(99)90009-4.

  PMID: 9989768 BACKGROUND

• Lorentsen KJ, Hendrix CW, Collins JM, Kornhauser DM, Petty BG, Klecker RW, Flexner C, Eckel RH, Lietman PS. Dextran sulfate is poorly absorbed after oral administration. Ann Intern Med. 1989 Oct 1;111(7):561-6. doi: 10.7326/0003-4819-111-7-561.

  PMID: 2476054 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Thrombosis

Interventions

Dextran Sulfate

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; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• P Lietman

  STUDY CHAIR

• KJ Lorentsen

  STUDY CHAIR

• CW Hendrix

  STUDY CHAIR

• JM Collins

  STUDY CHAIR

• DM Kornhauser

  STUDY CHAIR

• BG Petty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1989
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (1)