Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000983
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety of Different Dose Levels of Zidovudine 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:
A Randomized Blinded Trial To Evaluate the Safety and Tolerance of High Versus Low Dose Zidovudine Administered to Children With Human Immunodeficiency Virus
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 and compare differences in tolerance and side effects associated with two different dosages of zidovudine AZT when used to treat children with HIV infection Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are differences in the rate and degree of toxicities associated with one versus the other dosage
AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection Thus it is likely that symptomatic HIV infected children may also benefit from AZT Studies of the safety and pharmacokinetics blood levels in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic Those currently taking care of infected children no longer feel it is ethical to conduct an AZTplacebo inactive substance trial In addition given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses experience with an equivalent lower dose in children needs to be studied
AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection Thus it is likely that symptomatic HIV infected children may also benefit from AZT Studies of the safety and pharmacokinetics blood levels in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic Those currently taking care of infected children no longer feel it is ethical to conduct an AZTplacebo inactive substance trial In addition given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses experience with an equivalent lower dose in children needs to be studied
Detailed Description:
AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection Thus it is likely that symptomatic HIV infected children may also benefit from AZT Studies of the safety and pharmacokinetics blood levels in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic Those currently taking care of infected children no longer feel it is ethical to conduct an AZTplacebo inactive substance trial In addition given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses experience with an equivalent lower dose in children needs to be studied
All participants are randomized to receive AZT at 1 of 2 doses Patients are stratified according to whether CD4 cell counts are or 500 cellsmm3 as well as whether symptoms are mild to moderate or if patients have lymphocytic interstitial pneumonitis LIP Medication is dispensed every other week for the first 8 weeks and monthly until week 104 then either monthly or every 3 months Safety and effectiveness of the treatment program are evaluated at 6-month intervals to assess whether it is appropriate to continue the study as originally designed Patients are evaluated every 2 weeks for the first 8 weeks monthly until week 104 every 3 months until week 208 and then every 6 months thereafter
All participants are randomized to receive AZT at 1 of 2 doses Patients are stratified according to whether CD4 cell counts are or 500 cellsmm3 as well as whether symptoms are mild to moderate or if patients have lymphocytic interstitial pneumonitis LIP Medication is dispensed every other week for the first 8 weeks and monthly until week 104 then either monthly or every 3 months Safety and effectiveness of the treatment program are evaluated at 6-month intervals to assess whether it is appropriate to continue the study as originally designed Patients are evaluated every 2 weeks for the first 8 weeks monthly until week 104 every 3 months until week 208 and then every 6 months 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 |
|---|---|---|---|
| 11103 | REGISTRY | DAIDS ES Registry Number | None |