Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000695
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
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 Kaposis 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 Kaposis 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 Kaposis 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 Kaposis 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 Kaposis 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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11031 | REGISTRY | DAIDS ES Registry Number | None |