Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

19+ years

Phase:

NA

Brief Summary

To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. The effect of ...

Detailed 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...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

April 1 1991

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00000684

End Date

April 1 1991

Last Update

November 3 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States, 21287