Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000967
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety and Tolerance of Zidovudine and Interferon-Alpha in HIV-Infected Children
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:
PRIMARY To determine the maximum tolerated dose of interferon-alfa IFN-A alone and in combination with zidovudine AZT to assess the safety and tolerance of IFN-A alone and in combination with AZT
SECONDARY To evaluate the effect of combination IFN-A and AZT on immunologic and virologic parameters to determine whether the pharmacokinetic parameters of AZT are modified by the subcutaneous administration of IFN-A
AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex ARC However use of AZT is limited by its frequent toxicity which sometimes relates to the amount of drug given Thus a combination treatment of two drugs that work together may provide more effective and safer treatment IFN-A is a drug that has antiviral effects and may work well with AZT
SECONDARY To evaluate the effect of combination IFN-A and AZT on immunologic and virologic parameters to determine whether the pharmacokinetic parameters of AZT are modified by the subcutaneous administration of IFN-A
AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex ARC However use of AZT is limited by its frequent toxicity which sometimes relates to the amount of drug given Thus a combination treatment of two drugs that work together may provide more effective and safer treatment IFN-A is a drug that has antiviral effects and may work well with AZT
Detailed Description:
AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex ARC However use of AZT is limited by its frequent toxicity which sometimes relates to the amount of drug given Thus a combination treatment of two drugs that work together may provide more effective and safer treatment IFN-A is a drug that has antiviral effects and may work well with AZT
The study is being conducted in three stages In Cohort A IFN-A alone four patients receive IFN-A subsequent four-patient cohorts receive doses escalated in increments If 50 percent or more of patients at any dose level experience grade 2 or better toxicity doses in subsequent cohorts are escalated If grade 3 or 4 toxicity is seen in one patient at a given dose level two additional patients are enrolled at that level Treatment is given subcutaneously under the skin with a needle 3 times per week for 12 weeks The MTD is defined as the dose level immediately below that at which 50 percent or more of patients experience grade 3 or 4 toxicity In Cohort B combination IFN-A plus AZT patients who complete treatment in Cohort A continue on the same dose of IFN-A and a low middle or high dose of AZT is added In Cohort C four newly assigned patients who have been on a stable prescribed dose of AZT of at least 90 mgm2 for 6 weeks are treated at each of the same dose combinations as those in Cohort B Treatment is given for 12 weeks IFN-A is given subcutaneously 3 times a week and AZT is given orally every 6 hours Dose levels of both drugs are increased until 50 percent or more of patients experience grade 3 or 4 toxicity in any dose level
The study is being conducted in three stages In Cohort A IFN-A alone four patients receive IFN-A subsequent four-patient cohorts receive doses escalated in increments If 50 percent or more of patients at any dose level experience grade 2 or better toxicity doses in subsequent cohorts are escalated If grade 3 or 4 toxicity is seen in one patient at a given dose level two additional patients are enrolled at that level Treatment is given subcutaneously under the skin with a needle 3 times per week for 12 weeks The MTD is defined as the dose level immediately below that at which 50 percent or more of patients experience grade 3 or 4 toxicity In Cohort B combination IFN-A plus AZT patients who complete treatment in Cohort A continue on the same dose of IFN-A and a low middle or high dose of AZT is added In Cohort C four newly assigned patients who have been on a stable prescribed dose of AZT of at least 90 mgm2 for 6 weeks are treated at each of the same dose combinations as those in Cohort B Treatment is given for 12 weeks IFN-A is given subcutaneously 3 times a week and AZT is given orally every 6 hours Dose levels of both drugs are increased until 50 percent or more of patients experience grade 3 or 4 toxicity in any dose level
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 |
|---|---|---|---|
| 11128 | REGISTRY | DAIDS ES Registry Number | None |