Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000716
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection
Status:
COMPLETED
Status Verified Date:
1990-05
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 tolerance of oral zidovudine AZT when given over a period of 24 weeks to children between 3 months and 12 years of age The effectiveness of AZT in treating HIV infection in infants and children will also be evaluated
HIV infection in children is most often associated with symptomatic disease and poor prognosis Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children AZT has been shown to be effective in certain adult patients with symptomatic HIV infection It is therefore likely that infected children may also benefit from this treatment
HIV infection in children is most often associated with symptomatic disease and poor prognosis Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children AZT has been shown to be effective in certain adult patients with symptomatic HIV infection It is therefore likely that infected children may also benefit from this treatment
Detailed Description:
HIV infection in children is most often associated with symptomatic disease and poor prognosis Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children AZT has been shown to be effective in certain adult patients with symptomatic HIV infection It is therefore likely that infected children may also benefit from this treatment
The participants receive AZT mixed with juice at a dose dependent on body size every 6 hours for 24 weeks The children are evaluated weekly for the first 4 weeks every two weeks for the subsequent 8 weeks and monthly thereafter Blood samples are collected periodically and cerebrospinal fluid CSF by lumbar puncture on 2 occasions
The participants receive AZT mixed with juice at a dose dependent on body size every 6 hours for 24 weeks The children are evaluated weekly for the first 4 weeks every two weeks for the subsequent 8 weeks and monthly thereafter Blood samples are collected periodically and cerebrospinal fluid CSF by lumbar puncture on 2 occasions
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 |
|---|---|---|---|
| FDA 9C | None | None | None |
| NCI-T88-0191N | None | None | None |
| Protocol 26341--08 | None | None | None |
| Project P53 | None | None | None |