Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
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|ClinicalTrials.gov Identifier: NCT00000684|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 3, 2021
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 dextran sulfate on platelet survival will also be assessed in 3 patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all patients receiving intravenous dextran sulfate in this study.
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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Dextran sulfate||Not Applicable|
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. The infusion is adjusted to maintain an activated partial thromboplastin time (APTT) of 50 to 65 seconds. Blood is withdrawn 5 times on the first day that patients receive dextran sulfate and at least once a day thereafter for safety. Patients' clinical condition, blood clotting, and blood platelets are monitored very closely.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||10 participants|
|Masking:||None (Open Label)|
|Official Title:||Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals|
|Actual Study Completion Date :||April 1991|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000684
|United States, Maryland|
|Johns Hopkins Adult AIDS CRS|
|Baltimore, Maryland, United States, 21287|
|Study Chair:||Lietman PS|
|Study Chair:||Flexner CW|