Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001113
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of AZT Plus Human Interferon Alpha in the Treatment of 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:
A Phase I Study of AZT and Human Interferon Alpha Recombinant Alpha-2A and Lymphoblastoid in the Treatment of AIDS-Associated 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 evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposis sarcoma with zidovudine AZT and two kinds of interferon alpha The two kinds are interferon alpha IFN-A and interferon alpha-2A recombinant IFN-A2A To define the pharmacokinetics of AZT and IFN-A or AZT and IFN-A2A when given in combination To define the maximum tolerated dose MTD of each drug in combination and to define doses to be used in Phase II trial AZT has been found to be effective against the effects of HIV in vitro test tube and both interferons have shown antiviral and antitumor effect on Kaposis sarcoma It is reasonable to assume that a synergism and an enhanced antitumor response may be seen with combination therapy A study to evaluate the safety and effectiveness of AZT in the combination with IFN-A2A is warranted
Detailed Description:
AZT has been found to be effective against the effects of HIV in vitro test tube and both interferons have shown antiviral and antitumor effect on Kaposis sarcoma It is reasonable to assume that a synergism and an enhanced antitumor response may be seen with combination therapy A study to evaluate the safety and effectiveness of AZT in the combination with IFN-A2A is warranted
Patients are randomized to receive IFN-A or IFN-A2A by intramuscular injection and combined with AZT orally daily for 8 weeks Two cohorts of 4 patients enter each dose level Patients do not enter into the next dose level until all patients have completed 3 weeks of treatment AZT escalates only if there is no unacceptable toxicity grade 2 in or 3 patients or grade 2 in any patients subsequent increase in IFN-A or IFN-A2A will be permitted but the AZT dose will remain fixed The MTD for a given IFN-A or IFN-A2A dose level is defined as grade 3 toxicity for hemoglobin or grade 2 toxicity for other parameters in 3 of the 6 patients Once the MTD is reached there will be no further enrollment at higher dose level Patients are followed every week for vital signs and hematologic studies Patients tolerating the combination may be continued on therapy for 1 year at the same dose as the end of 8th week
Patients are randomized to receive IFN-A or IFN-A2A by intramuscular injection and combined with AZT orally daily for 8 weeks Two cohorts of 4 patients enter each dose level Patients do not enter into the next dose level until all patients have completed 3 weeks of treatment AZT escalates only if there is no unacceptable toxicity grade 2 in or 3 patients or grade 2 in any patients subsequent increase in IFN-A or IFN-A2A will be permitted but the AZT dose will remain fixed The MTD for a given IFN-A or IFN-A2A dose level is defined as grade 3 toxicity for hemoglobin or grade 2 toxicity for other parameters in 3 of the 6 patients Once the MTD is reached there will be no further enrollment at higher dose level Patients are followed every week for vital signs and hematologic studies Patients tolerating the combination may be continued on therapy for 1 year at the same dose as the end of 8th week
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 |
|---|---|---|---|
| 10990 | REGISTRY | DAIDS ES Registry Number | None |