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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1
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287