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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000690

Purpose

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	Intervention	Phase
HIV Infections	Drug: Dextran sulfate	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Dextrans Dextran sulfate sodium Dextran sulfate

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000690

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.

ClinicalTrials.gov Identifier:	NCT00000690 History of Changes
Other Study ID Numbers:	ACTG 078
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes

Immune System Diseases
Slow Virus Diseases
Dextrans
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on February 09, 2012