Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000684
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11080 | REGISTRY | DAIDS ES Registry Number | None |