NCT00073424

Brief Summary

Taking anti-HIV medication consistently and properly is a critical issue for patients with HIV. Drug regimens are complex; when regimens are not taken properly, HIV can become resistant to the drugs. Taking anti-HIV medication properly leads to improved health. Children and adolescents with HIV face unique challenges to taking HIV medication properly. This study will look at the relationship between how children cope with the responsibility for taking medication and the child's language, memory, attention, behavior, and academic skills. This study is open to children and adolescents who are currently enrolled in the PACTG 219C study (Long-Term Effects of HIV Exposure and Infection in Children).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
2 countries

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

First QC Date

November 20, 2003

Last Update Submit

May 31, 2013

Conditions

Keywords

Treatment Experienced

Eligibility Criteria

Age8 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV-1 perinatal infection
  • Already enrolled and in active follow-up in PACTG 219C
  • Can communicate in English or Spanish
  • On antiretroviral medication regimen at the time of enrollment, regardless of compliance with regimen, with no planned treatment interruptions

You may not qualify if:

  • Acquired HIV via routes other than perinatal transmission or source of HIV infection is unknown
  • HIV-2 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

UAB, Dept. of Ped., Div. of Infectious Diseases

Birmingham, Alabama, 35233, United States

Location

Phoenix Children's Hosp.

Phoenix, Arizona, 85006, United States

Location

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, 90801, United States

Location

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, California, 94609-1809, United States

Location

UCSD Mother-Child-Adolescent Program CRS

San Diego, California, 92103, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, 94143-0105, United States

Location

Univ. of Colorado Denver NICHD CRS

Denver, Colorado, 80218-1088, United States

Location

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, 06504, United States

Location

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, 20010, United States

Location

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

South Florida CDTC Ft Lauderdale NICHD CRS

Fort Lauderdale, Florida, 33316, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33136, United States

Location

Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Augusta, Georgia, 30912, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112-2699, United States

Location

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center, Springfield

Springfield, Massachusetts, 01199, United States

Location

NJ Med. School CRS

Newark, New Jersey, 07101-1709, United States

Location

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

Brooklyn, New York, 11203-2098, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, 10037, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 11794-8111, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

Jacobi Med. Ctr.

The Bronx, New York, 10461, United States

Location

UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases

Chapel Hill, North Carolina, 27599-7220, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27705, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, 19104-4318, United States

Location

St. Christopher's Hosp. for Children

Philadelphia, Pennsylvania, 19134, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105-2794, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 00936-5067, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, Puerto Rico

Location

Related Publications (6)

  • Catz SL, Kelly JA, Bogart LM, Benotsch EG, McAuliffe TL. Patterns, correlates, and barriers to medication adherence among persons prescribed new treatments for HIV disease. Health Psychol. 2000 Mar;19(2):124-33.

    PMID: 10762096BACKGROUND
  • Gordillo V, del Amo J, Soriano V, Gonzalez-Lahoz J. Sociodemographic and psychological variables influencing adherence to antiretroviral therapy. AIDS. 1999 Sep 10;13(13):1763-9. doi: 10.1097/00002030-199909100-00021.

    PMID: 10509579BACKGROUND
  • Rogers AS, Miller S, Murphy DA, Tanney M, Fortune T. The TREAT (Therapeutic Regimens Enhancing Adherence in Teens) program: theory and preliminary results. J Adolesc Health. 2001 Sep;29(3 Suppl):30-8. doi: 10.1016/s1054-139x(01)00289-0. No abstract available.

    PMID: 11530301BACKGROUND
  • Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51. doi: 10.1542/peds.113.6.e544.

    PMID: 15173535BACKGROUND
  • Farley JJ, Montepiedra G, Storm D, Sirois PA, Malee K, Garvie P, Kammerer B, Naar-King S, Nichols S; PACTG P1042S Team. Assessment of adherence to antiretroviral therapy in perinatally HIV-infected children and youth using self-report measures and pill count. J Dev Behav Pediatr. 2008 Oct;29(5):377-84. doi: 10.1097/DBP.0b013e3181856d22.

  • Naar-King S, Montepiedra G, Nichols S, Farley J, Garvie PA, Kammerer B, Malee K, Sirois PA, Storm D; PACTG P1042S Team. Allocation of family responsibility for illness management in pediatric HIV. J Pediatr Psychol. 2009 Mar;34(2):187-94. doi: 10.1093/jpepsy/jsn065. Epub 2008 Jun 27.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sharon Nichols, PhD

    Department of Neurosciences, University of California, San Diego

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2003

First Posted

November 21, 2003

Study Start

January 1, 2004

Study Completion

October 1, 2006

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations