Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000728
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy
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 short-term effects of administering zidovudine AZT at the same time with increasing doses of aldesleukin interleukin-2 IL-2 in patients with persistent generalized lymphadenopathy syndrome PGL The effects to be studied include safety or toxicity how quickly the drugs are used in the body effects on the immune system effects on HIV concentrations in body fluids and how quickly the drugs are cleared by the kidneys The trial will establish the maximum tolerated dose MTD and will be a pilot study to determine the dose that has the greatest effect in the immune system
AZT has been shown to be effective in HIV-related disease IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube IL-2 has also been effective in treating Kaposis sarcoma in a number of patients Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects
AZT has been shown to be effective in HIV-related disease IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube IL-2 has also been effective in treating Kaposis sarcoma in a number of patients Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects
Detailed Description:
AZT has been shown to be effective in HIV-related disease IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube IL-2 has also been effective in treating Kaposis sarcoma in a number of patients Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects
Patients enter the study in staggered groups of five All patients receive AZT orally every 4 hours for 12 weeks At the end of 8 weeks the first group of five patients receive the lowest dosage of IL-2 on a daily basis while still receiving AZT Toxicity and immunologic effects are measured at the beginning of AZT therapy and then every 2 weeks Each succeeding group of five patients receives a higher dose of IL-2 while receiving AZT until the MTD is reached Those patients who have shown no toxicity as well as improved immune function while taking both drugs receive a 4-week follow-up course of IL-2 5 weeks after stopping AZT In addition five patients who have completed the AZT IL-2 combined treatment without significant toxicity are re-treated with 12 weeks of AZT alone starting 8 weeks after completing the initial combined AZT IL-2 portion of treatment Another five patients will be re-treated with 12 weeks of full dose of AZT alone followed by 8 weeks of half-dose AZT alone starting 8 weeks after completing the initial combined AZT IL-2 treatment Patients receive ibuprofen for fever and chills and those who reach their MTD continue to receive that dose in combination with AZT for 4 weeks If excess toxicity is observed on all doses of IL-2 the study will be discontinued
Patients enter the study in staggered groups of five All patients receive AZT orally every 4 hours for 12 weeks At the end of 8 weeks the first group of five patients receive the lowest dosage of IL-2 on a daily basis while still receiving AZT Toxicity and immunologic effects are measured at the beginning of AZT therapy and then every 2 weeks Each succeeding group of five patients receives a higher dose of IL-2 while receiving AZT until the MTD is reached Those patients who have shown no toxicity as well as improved immune function while taking both drugs receive a 4-week follow-up course of IL-2 5 weeks after stopping AZT In addition five patients who have completed the AZT IL-2 combined treatment without significant toxicity are re-treated with 12 weeks of AZT alone starting 8 weeks after completing the initial combined AZT IL-2 portion of treatment Another five patients will be re-treated with 12 weeks of full dose of AZT alone followed by 8 weeks of half-dose AZT alone starting 8 weeks after completing the initial combined AZT IL-2 treatment Patients receive ibuprofen for fever and chills and those who reach their MTD continue to receive that dose in combination with AZT for 4 weeks If excess toxicity is observed on all doses of IL-2 the study will be discontinued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11000 | REGISTRY | DAIDS ES Registry Number | None |