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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000690
• Other study ID #: ACTG 078
• Secondary ID: 11053
• Status: Completed
• Phase: Phase 1
• Est. completion date: October 1989

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 1989
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Dextran sulfate

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation