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A Pre-Enrollment Protocol for HIV-Infected Adolescents

A Pre-Enrollment Protocol for HIV-Infected Adolescents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00000780
Enrollment
250
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Adolescent Behavior

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).

Interventions

None listed

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Eligibility

Sex/Gender
ALL
Age
13 Years to 20 Years
Healthy volunteers
No

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.

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026