Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001009
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Dose Ranging Trial of Oral Dextran Sulfate UA001 in HIV Infected Individuals and in Patients With Acquired Immunodeficiency Syndrome AIDS or AIDS Related Complex ARC
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 effectiveness and safety of dextran sulfate DS as a treatment for patients with AIDS AIDS related complex ARC or asymptomatic HIV infection with or without persistent generalized lymphadenopathy PGL and to determine antiviral activity at different doses of DS Although zidovudine AZT has shown promise in prolonging life in patients with AIDS and severe ARC it has significant blood toxicities It would be beneficial to combine AZT with another antiviral agent that does not have the same toxicity DS might be a suitable drug since it has shown antiviral activity against HIV in the laboratory and in preliminary studies it has shown little toxicity Also the combination of DS with AZT has been shown to be more effective than either alone
Detailed Description:
Although zidovudine AZT has shown promise in prolonging life in patients with AIDS and severe ARC it has significant blood toxicities It would be beneficial to combine AZT with another antiviral agent that does not have the same toxicity DS might be a suitable drug since it has shown antiviral activity against HIV in the laboratory and in preliminary studies it has shown little toxicity Also the combination of DS with AZT has been shown to be more effective than either alone
The study will begin with 10 patients with AIDS 10 with ARC and 10 with asymptomatic HIV infection taking DS by mouth 3 times a day for 24 weeks If the initial dose of DS is tolerated without significant side effects the next group of patients will receive a higher dose A third group of patients will be given either a higher or lower dose depending on the results of the earlier groups Patients will be evaluated every other week for 12 weeks then monthly for the remaining 16 weeks Patients will have the option of continuing DS until the entire study is completed if the drug is well tolerated Inhaled pentamidine for the prevention of Pneumocystis carinii pneumonia is allowed but other investigational drugs are not Drug effects on the HIV virus immune function and clinical condition will be monitored during the periodic evaluations
The study will begin with 10 patients with AIDS 10 with ARC and 10 with asymptomatic HIV infection taking DS by mouth 3 times a day for 24 weeks If the initial dose of DS is tolerated without significant side effects the next group of patients will receive a higher dose A third group of patients will be given either a higher or lower dose depending on the results of the earlier groups Patients will be evaluated every other week for 12 weeks then monthly for the remaining 16 weeks Patients will have the option of continuing DS until the entire study is completed if the drug is well tolerated Inhaled pentamidine for the prevention of Pneumocystis carinii pneumonia is allowed but other investigational drugs are not Drug effects on the HIV virus immune function and clinical condition will be monitored during the periodic evaluations
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 |
|---|---|---|---|
| 11034 | REGISTRY | DAIDS ES Registry Number | None |