HIV InfectionsNCT00000780
A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- HIV Infections
- How many people
- 250 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must meet the following criteria:
- HIV infection.
- NOT currently enrolled in an ACTG treatment protocol.
Who cannot join
- Co-existing Condition:
- Participants with the following condition are excluded:
- No legal provision for consent to participate in clinical research can be determined.
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States48 sites
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, 452292899
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Columbus Children's Hosp
Columbus, Ohio, 432052696
West Central Ohio Hemophilia Ctr / Children's Med Ctr
Dayton, Ohio, 454041815
Children's Hosp of Denver
Denver, Colorado, 802181088
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
Children's Hosp of Los Angeles
Los Angeles, California, 90027
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
Univ of Miami (Pediatric)
Miami, Florida, 33161
Schneider Children's Hosp
New Hyde Park, New York, 11040
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029
Mount Sinai Med Ctr
New York, New York, 10029
Harlem Hosp Ctr
New York, New York, 10037
Children's Hosp of Oakland
Oakland, California, 946091809
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
Westchester Hosp
Valhalla, New York, 10595
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605
Puerto Rico3 sites
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
San Juan City Hosp
San Juan, 009367344
About this study
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.
Read the 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).
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Adolescent Behavior
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Adolescent Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 250 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- D'Angelo LJ, Study chairFutterman D, Study chairAbdalian S, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000780
- Sponsor's protocol ID
- ACTG 220
- Status last verified
- Mar 2003
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 7814276D'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.
PubMed 11362042Perrier 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.
PubMed 21037891
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A "Pre-Enrollment" Protocol for HIV-Infected Adolescents
- ClinicalTrials.gov ID
- NCT00000780
- Acronym / sponsor ID
- ACTG 220
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Adolescent Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- HIV infection.
- NOT currently enrolled in an ACTG treatment protocol.
Key exclusion criteria (3 listed)
- No legal provision for consent to participate in clinical research can be determined.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 7814276Fry LJ, Fernandez RA. HIV prevention: factors that predict compliance with testing and counseling procedures. J Am Osteopath Assoc. 1994 Oct;94(10):825-30.
- Background: PubMed 11362042D'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.
- Background: PubMed 21037891Perrier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D'Angelo LJ study chair
Futterman D study chair
Abdalian S study chair
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 51 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000780, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.