Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000720
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Double-Blind Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
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 the clinical immunologic and virologic effects of oral zidovudine AZT plus intravenous immunoglobulin IVIG versus AZT plus placebo albumin It is estimated that by 1991 there may be 10000 to 20000 HIV-infected children in the United States HIV infection in children is most often associated with symptomatic disease and poor prognosis Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients therefore it is likely that children may also benefit from this antiviral therapy In addition bacterial infections are frequently found in HIV-infected children Because pooled human serum immunoglobulin another name for antibodies is effective in reducing bacterial infection in patients with defects of immunity it may reduce the rate of bacterial infection in HIV-infected children as well In this study AZT will be administered together with IVIG to determine safety tolerance and efficacy of the combined treatment
Detailed Description:
It is estimated that by 1991 there may be 10000 to 20000 HIV-infected children in the United States HIV infection in children is most often associated with symptomatic disease and poor prognosis Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients therefore it is likely that children may also benefit from this antiviral therapy In addition bacterial infections are frequently found in HIV-infected children Because pooled human serum immunoglobulin another name for antibodies is effective in reducing bacterial infection in patients with defects of immunity it may reduce the rate of bacterial infection in HIV-infected children as well In this study AZT will be administered together with IVIG to determine safety tolerance and efficacy of the combined treatment
The study includes 250 children 3 months to 12 years of age All participants receive oral AZT IVIG or intravenous placebo is administered every 28 days Patients are followed for the development of serious bacterial infection as well as for a number of factors relating to safety tolerance progression of disease and survival This is an outpatient study conducted over a minimum 100-week period The children are evaluated every 2 weeks for the first 8 weeks and monthly thereafter
The study includes 250 children 3 months to 12 years of age All participants receive oral AZT IVIG or intravenous placebo is administered every 28 days Patients are followed for the development of serious bacterial infection as well as for a number of factors relating to safety tolerance progression of disease and survival This is an outpatient study conducted over a minimum 100-week period The children are evaluated every 2 weeks for the first 8 weeks and monthly 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 |
|---|---|---|---|
| 11025 | REGISTRY | DAIDS ES Registry Number | None |