A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
NCT ID: NCT00000780
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
Brief Summary
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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
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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).
Conditions
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Eligibility Criteria
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Inclusion Criteria
* HIV infection.
* NOT currently enrolled in an ACTG treatment protocol.
Exclusion Criteria
Participants with the following condition are excluded:
* No legal provision for consent to participate in clinical research can be determined.
13 Years
20 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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D'Angelo LJ
Role: STUDY_CHAIR
Futterman D
Role: STUDY_CHAIR
Abdalian S
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States
Long Beach Memorial (Pediatric)
Long Beach, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States
Children's Hosp of Los Angeles
Los Angeles, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Westchester Hosp
Valhalla, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Columbus Children's Hosp
Columbus, Ohio, United States
West Central Ohio Hemophilia Ctr / Children's Med Ctr
Dayton, Ohio, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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Fry LJ, Fernandez RA. HIV prevention: factors that predict compliance with testing and counseling procedures. J Am Osteopath Assoc. 1994 Oct;94(10):825-30.
D'Angelo LJ, Lindsey J, Zimmer B, Culnane M, Futtermann D. Attempting to enhance the enrollment of adolescents into AIDS clinical trials: the design of ACTG Protocol 220. AIDS Patient Care STDS. 1998 Nov;12(11):853-9. doi: 10.1089/apc.1998.12.853.
Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
Other Identifiers
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ACTG 220
Identifier Type: -
Identifier Source: org_study_id