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

Trial Information

Current as of December 09, 2024

Completed

Keywords

Infusions, Intravenous Dextran Sulfate Acquired Immunodeficiency Syndrome

ClinConnect Summary

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.

Trial Officials

Lietman PS

Study Chair

Flexner CW

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Baltimore, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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