Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006304
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2000-09-27
Brief Title:
Long-Term Effects of HIV Exposure and Infection in Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pediatric Late Outcomes Protocol
Status:
COMPLETED
Status Verified Date:
2013-10
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:
As new drugs and vaccines are developed to prevent HIV disease progression and prolong survival of HIV infected patients the short-term safety and effectiveness of these treatments are evaluated in research studies However the long-term effects whether they are benefits or side effects need to be studied as well These long-term effects may have a greater impact on infants and children who are still growing and developing The purpose of this study is to follow HIV-exposed and HIV infected infants children and adolescents who are seen at Pediatric AIDS Clinical Trials Group PACTG study sites These patients will be observed for long-term benefits or any late harmful effects of medications or vaccines
Detailed Description:
The potential long-term benefits toxicities and other adverse outcomes of new anti-HIV therapies cannot be assessed within the time frame of most clinical trials There is a need to better assess both positive and negative late outcomes and late treatment effects in growing children This prospective longitudinal study will evaluate the effects and their impact on children
Children in this study will include patients who are HIV infected were exposed to HIV or anti-HIV drugs prior to or at the time of their birth or children of patients followed at Pediatric AIDS Clinical Trial Group PACTG sites Children will have a study visit every 3 months through the first year of life After age 1 children who are HIV infected will continue to have study visits every 3 months while children who are HIV uninfected will have study visits once a year Study assessments will include complete physical exam medical history Tanner staging neurologic exam growth and quality of life assessments and laboratory tests such as hematology chemistries and urinalysis Not all assessments will be performed at each study visit Patients will be followed until age 24
Children in this study will include patients who are HIV infected were exposed to HIV or anti-HIV drugs prior to or at the time of their birth or children of patients followed at Pediatric AIDS Clinical Trial Group PACTG sites Children will have a study visit every 3 months through the first year of life After age 1 children who are HIV infected will continue to have study visits every 3 months while children who are HIV uninfected will have study visits once a year Study assessments will include complete physical exam medical history Tanner staging neurologic exam growth and quality of life assessments and laboratory tests such as hematology chemistries and urinalysis Not all assessments will be performed at each study visit Patients will be followed until age 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11196 | REGISTRY | DAIDS ES | None |
| ACTG 219 | None | None | None |
| PACTG 219C | None | None | None |