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


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Dextran

Gentran 40; LMD



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

This study has been completed.

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

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 Treatment or Intervention Phase
HIV Infections
 Drug: Dextran sulfate
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study

Further Study Details: 

Expected Total Enrollment:  6

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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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   -   40 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

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.

Location Information


Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States

Study chairs or principal investigators

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

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.

Study ID Numbers:  ACTG 078
Record last reviewed:  June 1989
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000690
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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