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

June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Ramon Ruiz Arnau Univ Hosp / Pediatrics
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham Schl of Med / Pediatrics
    • California
      • Long Beach, California, United States, 90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles, California, United States, 90027
        • Children's Hosp of Los Angeles
      • Los Angeles, California, United States, 900276016
        • Children's Hosp of Los Angeles/UCLA Med Ctr
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, United States, 900951752
        • UCLA Med Ctr / Pediatric
      • Oakland, California, United States, 946091809
        • Children's Hosp of Oakland
      • San Francisco, California, United States, 941430105
        • UCSF / Moffitt Hosp - Pediatric
    • Colorado
      • Denver, Colorado, United States, 802181088
        • Children's Hosp of Denver
    • District of Columbia
      • Washington, District of Columbia, United States, 200102916
        • Children's Hosp of Washington DC
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ / Hershey Med Ctr
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, United States, 33161
        • Univ of Miami (Pediatric)
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory Univ Hosp / Pediatrics
    • Illinois
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, United States, 606371470
        • Univ of Chicago Children's Hosp
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ / Charity Hosp of New Orleans
      • New Orleans, Louisiana, United States, 70112
        • Tulane Med Ctr Hosp
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 021155724
        • Children's Hosp of Boston
      • Boston, Massachusetts, United States, 02118
        • Boston City Hosp / Pediatrics
      • Worcester, Massachusetts, United States, 01605
        • Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
    • Nebraska
      • Omaha, Nebraska, United States, 681985130
        • Univ of Nebraska Med Ctr
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Med Ctr Adolescent AIDS Program
      • Bronx, New York, United States, 10457
        • Bronx Lebanon Hosp Ctr
      • Brooklyn, New York, United States, 11203
        • King's County Hosp Ctr / Pediatrics
      • Buffalo, New York, United States, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • Buffalo, New York, United States, 14222
        • Children's Hosp Pact Prog / Children's Hosp of Buffalo
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hosp
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10037
        • Harlem Hosp Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr / Pediatrics
      • Valhalla, New York, United States, 10595
        • Westchester Hosp
    • North Carolina
      • Durham, North Carolina, United States, 277103499
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati
      • Cincinnati, Ohio, United States, 452292899
        • Cincinnati Children's Hosp / Univ Hosp
      • Columbus, Ohio, United States, 432052696
        • Columbus Children's Hosp
      • Dayton, Ohio, United States, 454041815
        • West Central Ohio Hemophilia Ctr / Children's Med Ctr
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 170330850
        • Milton S Hershey Med Ctr
      • Philadelphia, Pennsylvania, United States, 191044318
        • Children's Hosp of Philadelphia
      • Philadelphia, Pennsylvania, United States, 191341095
        • Saint Christopher's Hosp for Children
    • South Carolina
      • Charleston, South Carolina, United States, 294253312
        • Med Univ of South Carolina
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
      • Memphis, Tennessee, United States, 381052794
        • Saint Jude Children's Research Hosp of Memphis
    • Texas
      • Houston, Texas, United States, 77030
        • Univ Texas Health Science Ctr / Univ Texas Med School
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 532130127
        • Great Lakes Hemophilia Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: D'Angelo LJ
  • Study Chair: Futterman D
  • Study Chair: Abdalian S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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