Search / Trial NCT00000684

Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Infusions, Intravenous Dextran Sulfate Acquired Immunodeficiency Syndrome

Description

Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously will have antiviral effects in patients who are infected with HIV. Following tests for evaluation, patients are hospitalized for 14 days. They are admitted to the hospital in the afternoon and, starting the next morning, receive a continuous infusion of dextran sulfate through an intravenous line for 14 days. T...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Acetaminophen.
  • Patients must have:
  • -
  • Clinically documented AIDS or AIDS-related complex (ARC) defined as CDC group IVA or history of any of the findings that define CDC group IV subgroup C-2:
  • oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia, or nocardiosis.
  • Prior Medication:
  • Allowed:
  • Acetaminophen.
  • Exclusion Criteria
  • Concurrent Treatment:
  • Excluded:
  • Intramuscular injections.
  • Patients will be excluded from the study for the following reasons:
  • Acute illness requiring hospitalization or antiviral drug therapy for treatment.
  • Volunteers who have taken any antiviral medications, anticoagulants, antiplatelet medications, or any nonsteroidal anti-inflammatory drugs, except acetaminophen, within 2 weeks of study entry, or those who anticipate the need for such medication during the study.
  • Positive stool guaiac at screening.
  • Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi sarcoma (with or without proven gastrointestinal involvement), and any known CNS lesions that might be prone to bleed.
  • Allergy to dextran sulfate or heparin.
  • Acute or asymptomatic HIV infection.
  • Prior Medication:
  • Excluded:
  • Antiviral medications.
  • Anticoagulants.
  • Antiplatelet medications.
  • Any nonsteroidal anti-inflammatory drugs (except acetaminophen).
  • Prior Treatment:
  • Excluded:
  • Hospitalization for acute illness.
  • Patients may not have any of the following diseases or symptoms:
  • Allergy to dextran sulfate or heparin.
  • Acute or asymptomatic HIV infection.
  • Acute illness requiring hospitalization.
  • Chronic anemia requiring transfusion within the past month.
  • Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi's sarcoma, and any known CNS lesions which might be prone to bleed.

Attachments

readout_NCT00000684_2023-12-10.pdf

4.5 MB

NCT00000684_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Baltimore, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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