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).

Condition
HIV Infections

Further Study Details: 

Expected Total Enrollment:  200

Medication adherence is a critical issue for HIV infected children and adolescents because of drug resistance and the increased complexity of treatment regimens. Children and adolescents with HIV face depression, anxiety, denial, and rebellion that may interfere with their motivation to take medication. Depression and self-perceived social support have been found to predict regimen adherence in adults with HIV. Children with other chronic diseases are less likely to adhere to their medication regimens if they also have behavioral or emotional problems; assessing emotional and behavioral function in children and adolescents with HIV may help in predicting adherence and explaining adherence failure. This study will correlate cognitive, behavioral, and psychosocial functioning with measures of virologic suppression and immunological status, and it will compare self-report and pill count measures of adherence in a randomly selected subset of perinatally infected HIV participants of PACTG 219C.

Children and adolescents currently enrolled in PACTG 219C will be randomly selected for this study, which will last for 48 weeks. At entry, participants will undergo neuropsychological evaluation, including academic achievement, attention, memory, language comprehension, and behavior assessments, and complete a health beliefs questionnaire. Both the participants and their parents or primary caregivers will complete questionnaires at study entry and Weeks 24 and 48. Adherence will be evaluated from self-reported and pill count measures (Weeks 4 and 24) and the PACTG 219C Adherence Module (Weeks 24 and 48).

Ages Eligible for Study:  8 Years   -   19 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

Alabama
      University of Alabama at Birmingham (Pediatric), Birmingham,  Alabama,  35233,  United States
Arizona
      Phoenix Childrens Hospital, Phoenix,  Arizona,  85006,  United States
California
      Long Beach Memorial (Pediatric), Long Beach,  California,  90801,  United States
      UCSD Mother, Child & Adolescent HIV Program, San Diego,  California,  92103,  United States
      Los Angeles County Medical Center/USC, Los Angeles,  California,  90033,  United States
      Childrens Hospital, Oakland (Pediatric), Oakland,  California,  94609-1809,  United States
      UCSF, Moffitt Hospital (Pediatric), San Francisco,  California,  94143-0105,  United States
Colorado
      Childrens Hospital (U. Colorado, Denver), Denver,  Colorado,  80218-1088,  United States
Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  06504,  United States
District of Columbia
      Childrens National Medical Center, Washington,  District of Columbia,  20010,  United States
      Howard University Hospital, Washington,  District of Columbia,  20060,  United States
Florida
      North Broward Hospital District, Fort Lauderdale,  Florida,  33316,  United States
      University of Miami (Pediatric), Miami,  Florida,  33136,  United States
      University of Florida, Gainsville, Gainsville,  Florida,  32610-0296,  United States
Georgia
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      Chicago Childrens Memorial Hospital (Pediatrics), Chicago,  Illinois,  60614,  United States
      University of Illinois, Chicago,  Illinois,  60612-7234,  United States
Louisiana
      Tulane Univ., Charity Hospital of New Orleans, New Orleans,  Louisiana,  70112-2699,  United States
Maryland
      Johns Hopkins University (Pediatric), Baltimore,  Maryland,  United States
      University of Maryland (Pediatric), Baltimore,  Maryland,  21201,  United States
Massachusetts
      Baystate Medical Center, Springfield, Springfield,  Massachusetts,  01199,  United States
      Childrens Hospital of Boston, Boston,  Massachusetts,  02115,  United States
New Jersey
      Univ. of Med. & Dentistry of NJ/Univ. Hospital, Newark,  New Jersey,  07101-1709,  United States
New York
      Jacobi Medical Center, Bronx,  New York,  10461,  United States
      New York University School of Medicine, New York,  New York,  10016,  United States
      State University of New York at Stony Brook, Stony Brook,  New York,  11794-8111,  United States
      University of Rochester Medical Center, Rochester,  New York,  14642-0001,  United States
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States
      Harlem Hospital, New York,  New York,  10037,  United States
      Children's Hospital at Downstate, Brooklyn,  New York,  11203-2098,  United States
      Bronx Lebanon Hospital Center, Bronx,  New York,  10457,  United States
North Carolina
      Duke University (Pediatric), Durham,  North Carolina,  27705,  United States
      University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599-7220,  United States
Pennsylvania
      St. Christophers Hosp. for Children, Philadelphia, Philadelphia,  Pennsylvania,  19134,  United States
      Childrens Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104-4318,  United States
Tennessee
      St. Jude Children's Research Hospital, Memphis, Memphis,  Tennessee,  38105-2794,  United States
Texas
      Baylor (Texas Childrens Hospital)(Pediatric), Houston,  Texas,  77030,  United States
Puerto Rico
      San Juan City Hospital, San Juan,  Puerto Rico
      University of Puerto Rico, U. Childrens Hospital AIDS, San Juan,  00936-5067,  Puerto Rico

Study chairs or principal investigators

Sharon Nichols, PhD,  Study Chair,  Department of Neurosciences, University of California, San Diego   

Study ID Numbers:  PACTG P1042s
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  November 20, 2003
ClinicalTrials.gov Identifier:  NCT00073424
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08