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

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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)

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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

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.