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

• ClinicalTrials.gov Identifier: NCT00000690
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: November 2, 2021
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Dextran sulfate	Phase 1

Detailed Description:

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.

On 2nd day of hospitalization, each volunteer receives an oral dose of DS. Over the next 24 hours, 15 blood samples are obtained (from 15 separate needle sticks). On 4th day, each volunteer is given an injection of DS into vein. 18 blood samples are obtained. Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion. All urine is collected.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 6 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
• Actual Study Completion Date: October 1989

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Exclusion Criteria

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:

• Ingestion of alcohol within 48 hours prior to study.
• History of recent drug or alcohol abuse.
• Disorders of coagulation or disorders of plasma lipids.
• Allergy to dextran sulfate, other sulfates, other dextrans.

Volunteers selected are:

• In good general health as determined by screening history, physical examination, and laboratory panel within established limits of normal for hospital laboratory.
• Consenting volunteers.
• Available for 6 days of continuous hospitalization.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: P Lietman
• Study Chair: KJ Lorentsen
• Study Chair: CW Hendrix
• Study Chair: JM Collins
• Study Chair: DM Kornhauser
• Study Chair: BG Petty

More Information

Publications:

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.

Hiebert L, Jaques LB, Williams K, Conly J. Orally administered dextran sulphate is absorbed in HIV+ individual. Int Conf AIDS. 1991 Jun 16-21;7(2):107 (abstract no WA1060)

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.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00000690
• Other Study ID Numbers: ACTG 078; 11053 ( Registry Identifier: DAIDS ES Registry Number )
• First Posted: August 31, 2001
• Last Update Posted: November 2, 2021
• Last Verified: October 2021

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dextrans; Anticoagulants; Plasma Substitutes; Blood Substitutes