Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000690 |
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: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers |
Estimated 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 Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion.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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Exclusion Criteria
Co-existing Condition:
Volunteers with any of the following are excluded:
Concurrent Medication:
Excluded:
Volunteers with any of the following are excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
Risk Behavior:
Excluded:
Volunteers selected are:
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 |
Study Chair: | P Lietman | |
Study Chair: | KJ Lorentsen | |
Study Chair: | CW Hendrix | |
Study Chair: | JM Collins | |
Study Chair: | DM Kornhauser | |
Study Chair: | BG Petty |
Study ID Numbers: | ACTG 078 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000690 |
Health Authority: | United States: Federal Government |
Reference Values Infusions, Intravenous Intestinal Absorption |
Dextran Sulfate Administration, Oral Blood Coagulation |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Healthy Retroviridae Infections Immunologic Deficiency Syndromes Dextrans |
RNA Virus Infections Anticoagulants Slow Virus Diseases Immune System Diseases Therapeutic Uses Blood Substitutes |
Hematologic Agents Lentivirus Infections Plasma Substitutes Infection Pharmacologic Actions |