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A "Pre-Enrollment" Protocol for HIV-Infected Adolescents

This study has been completed.
Study NCT00000780.   Last updated on June 23, 2005.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
Official Title  A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
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 adolescent's 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.

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).

Study Phase
Study Type  Observational
Study Design  Natural History
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention 
MEDLINE PMIDs 7814276,   11362042,   11176565
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  250
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

Participants must meet the following criteria:

  • HIV infection.
  • NOT currently enrolled in an ACTG treatment protocol.

Exclusion Criteria

Co-existing Condition:

Participants with the following condition are excluded:

  • No legal provision for consent to participate in clinical research can be determined.
Gender Both
Ages 13 Years to 20 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Puerto Rico
Administrative Information Fields
NCT ID  NCT00000780
Organization ID ACTG 220
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     D'Angelo LJ        
Study Chair:     Futterman D        
Study Chair:     Abdalian S        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 2003
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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