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

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ClinicalTrials.gov Identifier: NCT00000780
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.


Condition or disease
HIV Infections

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 Design
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Study Type : Observational
Enrollment : 250 participants
Official Title: A "Pre-Enrollment" Protocol for HIV-Infected Adolescents

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000780


  Show 51 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: D'Angelo LJ
Study Chair: Futterman D
Study Chair: Abdalian S
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00000780     History of Changes
Other Study ID Numbers: ACTG 220
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2003

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Adolescent Behavior

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases