Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000990
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children With Mild to Moderate Symptoms
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Placebo-Controlled Trial To Evaluate the Safety and Efficacy of Oral Zidovudine in the Treatment of Children Infected With Human Immunodeficiency Virus With Mild to Moderate Symptoms Including LIP
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 safety and usefulness of zidovudine AZT for the treatment of children 3 months to 12 years of age This study is designed to determine if children who are infected with HIV and who have a special type of lung disease called lymphocytic interstitial pneumonitis LIP or other early symptoms of HIV infection may derive benefit from treatment with AZT It is hoped that this drug will prevent children from developing additional symptoms and infections and will help resolve already existing symptoms
AZT has been shown in the laboratory to inhibit the infection of cells by HIV AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection It is therefore likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy
AZT has been shown in the laboratory to inhibit the infection of cells by HIV AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection It is therefore likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy
Detailed Description:
AZT has been shown in the laboratory to inhibit the infection of cells by HIV AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection It is therefore likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy
Children who participate in the study are evaluated at a hospital outpatient clinic and are under the care of a specialist in pediatrics Of the children who participate in the study half receive AZT syrup and half receive a placebo sugar solution The investigator does not know which medication each child receives as this is decided by a random process The children take the medication in a strawberry-flavored clear syrup every 6 hours 4 times a day for a period of 2 years or 104 weeks The children are monitored on an outpatient basis while receiving therapy and the tests performed on admission to the study are repeated several times during treatment Blood samples are obtained once a week for the first 4 weeks every other week for the next 4 weeks and then monthly until the end of the study At certain sites Cerebrospinal fluid CSF is collected by lumbar puncture every 52 weeks to evaluate infection involving the brain and nervous system An independent committee reviews the data collected on the children every 6 months The drug is stopped or the dose reduced if unacceptable side effects develop AMENDED As of August 7 1989 the study blind was broken the placebo arm discontinued and the study closed to accrual as of September 25 1989 The 6 children enrolled in the study have been offered AZT
Children who participate in the study are evaluated at a hospital outpatient clinic and are under the care of a specialist in pediatrics Of the children who participate in the study half receive AZT syrup and half receive a placebo sugar solution The investigator does not know which medication each child receives as this is decided by a random process The children take the medication in a strawberry-flavored clear syrup every 6 hours 4 times a day for a period of 2 years or 104 weeks The children are monitored on an outpatient basis while receiving therapy and the tests performed on admission to the study are repeated several times during treatment Blood samples are obtained once a week for the first 4 weeks every other week for the next 4 weeks and then monthly until the end of the study At certain sites Cerebrospinal fluid CSF is collected by lumbar puncture every 52 weeks to evaluate infection involving the brain and nervous system An independent committee reviews the data collected on the children every 6 months The drug is stopped or the dose reduced if unacceptable side effects develop AMENDED As of August 7 1989 the study blind was broken the placebo arm discontinued and the study closed to accrual as of September 25 1989 The 6 children enrolled in the study have been offered AZT
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 |
|---|---|---|---|
| 11026 | REGISTRY | DAIDS ES Registry Number | None |