Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-31 @ 2:35 AM
Study NCT ID:
NCT00000695
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma
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 highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption.
IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
Detailed Description:
IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
Patients undergo evaluations to determine the extent of their disease and the status of their immune system. Patients then receive IFN-B subcutaneously once a day at one of three different dose levels. Patients also take AZT at 1 of 2 doses. The first 12 patients are treated with the lower dose of AZT. The first 4 patients are entered at level 1 of IFN-B. If no dose-limiting toxicity is seen in these 4 patients after 2 weeks of therapy, 4 patients are then enrolled at level 2 of IFN-B. The study proceeds in this manner until the highest tolerated dose or level 3 is reached. If both drugs are tolerated, patients then remain on both medications as long as they continue to tolerate the medications and show some improvement in either antiviral response, immune response, or clinical response for as long as 24 weeks. The initial three doses of IFN-B are given to each patient at the study site during which time the patient is trained to self-administer the IFN-B. Patients are then seen weekly for 4 months and every 2 weeks thereafter.
Patients undergo evaluations to determine the extent of their disease and the status of their immune system. Patients then receive IFN-B subcutaneously once a day at one of three different dose levels. Patients also take AZT at 1 of 2 doses. The first 12 patients are treated with the lower dose of AZT. The first 4 patients are entered at level 1 of IFN-B. If no dose-limiting toxicity is seen in these 4 patients after 2 weeks of therapy, 4 patients are then enrolled at level 2 of IFN-B. The study proceeds in this manner until the highest tolerated dose or level 3 is reached. If both drugs are tolerated, patients then remain on both medications as long as they continue to tolerate the medications and show some improvement in either antiviral response, immune response, or clinical response for as long as 24 weeks. The initial three doses of IFN-B are given to each patient at the study site during which time the patient is trained to self-administer the IFN-B. Patients are then seen weekly for 4 months and every 2 weeks thereafter.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11031 | REGISTRY | DAIDS ES Registry Number | View |