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NCT00000780 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
A "Pre-Enrollment" Protocol for HIV-Infected Adolescents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000780
Other study ID # ACTG 220
Secondary ID
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date March 2003
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 20 Years
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Emory Univ Hosp / Pediatrics Atlanta Georgia
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham Schl of Med / Pediatrics Birmingham Alabama
United States Boston City Hosp / Pediatrics Boston Massachusetts
United States Children's Hosp of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Montefiore Med Ctr Adolescent AIDS Program Bronx New York
United States King's County Hosp Ctr / Pediatrics Brooklyn New York
United States Children's Hosp Pact Prog / Children's Hosp of Buffalo Buffalo New York
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
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 Children's Hosp of Denver Denver Colorado
United States Duke Univ Med Ctr Durham North Carolina
United States Milton S Hershey Med Ctr Hershey Pennsylvania
United States Univ Texas Health Science Ctr / Univ Texas Med School Houston Texas
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr Knoxville Tennessee
United States Long Beach Memorial (Pediatric) Long Beach California
United States Children's Hosp of Los Angeles Los Angeles California
United States Children's Hosp of Los Angeles/UCLA Med Ctr 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 Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Schneider Children's Hosp New Hyde Park New York
United States Tulane Med Ctr Hosp New Orleans Louisiana
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Harlem Hosp Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Mount Sinai Med Ctr / Pediatrics New York New York
United States Children's Hosp of Oakland Oakland California
United States Univ of Nebraska Med Ctr Omaha Nebraska
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States Saint Christopher's Hosp for Children Philadelphia Pennsylvania
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Westchester Hosp Valhalla New York
United States Children's Hosp of Washington DC Washington District of Columbia
United States George Washington Univ / Hershey Med Ctr Washington District of Columbia
United States Georgetown Univ Med Ctr Washington District of Columbia
United States Great Lakes Hemophilia Foundation Wauwatosa Wisconsin
United States Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

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