Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000780
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Pre-Enrollment Protocol for HIV-Infected Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pre-Enrollment Protocol for HIV-Infected Adolescents
Status:
COMPLETED
Status Verified Date:
2003-03
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:
PRIMARY To identify characterize and co-enroll HIV-infected adolescents into existing and future ACTG or other NIH-sponsored HIV treatment protocols through the systematic and recurrent assessment of eligibility To assess the ability of adolescents enrolled in ACTG 220 to adhere to ACTG or other NIH-sponsored HIV treatment protocols and to define factors that influence the adolescents ability to enter or adhere to study protocols
SECONDARY To describe the nature stage and progression of HIV infection in adolescents
Little is known about HIV-infected adolescents as a group and as a result small numbers of them are currently enrolled in ACTG drug studies Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely
SECONDARY To describe the nature stage and progression of HIV infection in adolescents
Little is known about HIV-infected adolescents as a group and as a result small numbers of them are currently enrolled in ACTG drug studies Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely
Detailed Description:
Little is known about HIV-infected adolescents as a group and as a result small numbers of them are currently enrolled in ACTG drug studies Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely
At entry and at every subsequent visit participants are systematically evaluated for eligibility and willingness to enter ACTG or other NIH-sponsored HIV treatment protocols from a menu developed and updated by the Pediatric Adolescent Working Group of the ACTG A survey of participant attitudes behaviors and beliefs is administered and updated semiannually Participants attend clinic visits every 3 months and are followed for a minimum of 6 months until the end of the study They receive periodic physical exams STD and gynecologic or genitourinary evaluations HIV symptom assessment and related diagnoses TB evaluation and laboratory tests hematology and immunology
At entry and at every subsequent visit participants are systematically evaluated for eligibility and willingness to enter ACTG or other NIH-sponsored HIV treatment protocols from a menu developed and updated by the Pediatric Adolescent Working Group of the ACTG A survey of participant attitudes behaviors and beliefs is administered and updated semiannually Participants attend clinic visits every 3 months and are followed for a minimum of 6 months until the end of the study They receive periodic physical exams STD and gynecologic or genitourinary evaluations HIV symptom assessment and related diagnoses TB evaluation and laboratory tests hematology and immunology
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?: