Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001049
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
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 Evaluation of the Safety and Toxicity of Zidovudine and Didanosine in Combination in HIV-Infected or Exposed Infants and a Phase II Study of the Effect of Didanosine vs Combination Therapy With Zidovudine and Didanosine on HIV-1 RNA in Infants With HIV Infection
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 pharmacokinetics safety and efficacy of didanosine ddI alone or in combination with zidovudine AZT in HIV-infected infants
PER AMENDMENT 4897 Part A study objectives are completed Part B objectives To assess the safety toxicity and tolerability and to compare anti-HIV activity as measured by change in log10 RNA of the two study arms
Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function Combination therapy may be preferred over monotherapy since resistance to a single agent can develop rapidly Currently there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population
PER AMENDMENT 4897 Part A study objectives are completed Part B objectives To assess the safety toxicity and tolerability and to compare anti-HIV activity as measured by change in log10 RNA of the two study arms
Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function Combination therapy may be preferred over monotherapy since resistance to a single agent can develop rapidly Currently there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population
Detailed Description:
Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function Combination therapy may be preferred over monotherapy since resistance to a single agent can develop rapidly Currently there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population
In Part A a cohort of patients younger than 28 days was less than 120 days amended 62095 of age receives open-label ddI monotherapy for 1 week before initiation of AZTddI combination therapy After pharmacokinetic data are obtained an additional cohort of patients receives ddI at a higher dose An age-adjusted dose for ddI is determined for use in Part B NOTE As of 21395 Part A has completed accrued for infants 29 to 120 days of age Part B patients less than 90 days of age was less than 180 days of age amended 62095 are randomized on a double-blind basis to receive ddI or AZTddI All patients continue treatment until 12 months after the last patient on Part B is enrolled PER AMENDMENT 4897 Part A of this protocol is closed with accrual objectives met Part B of the study will remain open for patient accrual until 6297 Part B is designed as a 2-arm randomized double-blind study to assess safety toxicity and tolerability as well as anti-HIV activity of ddI or AZTddI
In Part A a cohort of patients younger than 28 days was less than 120 days amended 62095 of age receives open-label ddI monotherapy for 1 week before initiation of AZTddI combination therapy After pharmacokinetic data are obtained an additional cohort of patients receives ddI at a higher dose An age-adjusted dose for ddI is determined for use in Part B NOTE As of 21395 Part A has completed accrued for infants 29 to 120 days of age Part B patients less than 90 days of age was less than 180 days of age amended 62095 are randomized on a double-blind basis to receive ddI or AZTddI All patients continue treatment until 12 months after the last patient on Part B is enrolled PER AMENDMENT 4897 Part A of this protocol is closed with accrual objectives met Part B of the study will remain open for patient accrual until 6297 Part B is designed as a 2-arm randomized double-blind study to assess safety toxicity and tolerability as well as anti-HIV activity of ddI or AZTddI
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 |
|---|---|---|---|
| 11216 | REGISTRY | DAIDS ES Registry Number | None |