Long-Term Effects of HIV Exposure and Infection in Children

Pediatric Late Outcomes Protocol

Patrocinadores

Patrocinador principal: National Institute of Allergy and Infectious Diseases (NIAID)

Colaborador: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Fuente National Institute of Allergy and Infectious Diseases (NIAID)
Resumen breve

As new drugs and vaccines are developed to prevent HIV disease progression and prolong survival of HIV infected patients, the short-term safety and effectiveness of these treatments are evaluated in research studies. However, the long-term effects, whether they are benefits or side effects, need to be studied as well. These long-term effects may have a greater impact on infants and children who are still growing and developing. The purpose of this study is to follow HIV-exposed and HIV infected infants, children, and adolescents who are seen at Pediatric AIDS Clinical Trials Group (PACTG) study sites. These patients will be observed for long-term benefits or any late harmful effects of medications or vaccines.

Descripción detallada

The potential long-term benefits, toxicities, and other adverse outcomes of new anti-HIV therapies cannot be assessed within the time frame of most clinical trials. There is a need to better assess both positive and negative late outcomes and late treatment effects in growing children. This prospective, longitudinal study will evaluate the effects and their impact on children.

Children in this study will include patients who are HIV infected, were exposed to HIV or anti-HIV drugs prior to or at the time of their birth, or children of patients followed at Pediatric AIDS Clinical Trial Group (PACTG) sites. Children will have a study visit every 3 months through the first year of life. After age 1, children who are HIV infected will continue to have study visits every 3 months, while children who are HIV uninfected will have study visits once a year. Study assessments will include complete physical exam, medical history, Tanner staging, neurologic exam, growth and quality of life assessments, and laboratory tests such as hematology, chemistries, and urinalysis. Not all assessments will be performed at each study visit. Patients will be followed until age 24.

Estado general Completed
Fecha de Terminación May 2002
Tipo de estudio Observational
Inscripción 4150
Condición
Elegibilidad

Criterios:

Inclusion Criteria

- Age 21 or younger (consent of parent or guardian required if under 18).

- Meet 1 of the following 3 requirements: 1) enrolled in a previous version of this study; 2) perinatally exposed to HIV, HIV vaccines, or antiretroviral treatment (must enroll before first birthday); 3) HIV infected infants, children, and adolescents (and their offspring) followed at PACTG sites.

Exclusion Criteria

- Unable to adhere to study visit schedules.

Género: All

Edad mínima: N/A

Edad máxima: 21 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Ubicación
Instalaciones:
Univ of Alabama at Birmingham - Pediatric | Birmingham, Alabama, 35233, United States
Univ of South Alabama | Mobile, Alabama, 36604, United States
Phoenix Childrens Hosp | Phoenix, Arizona, 85006, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences | La Jolla, California, 920930672, United States
Long Beach Memorial (Pediatric) | Long Beach, California, 90801, United States
Children's Hosp of Los Angeles/UCLA Med Ctr | Los Angeles, California, 900276016, United States
Los Angeles County - USC Med Ctr | Los Angeles, California, 90033, United States
Cedars Sinai / UCLA Med Ctr | Los Angeles, California, 900481804, United States
UCLA Med Ctr / Pediatric | Los Angeles, California, 900951752, United States
UCLA Med Ctr / Pediatrics | Los Angeles, California, 90095, United States
UCLA Med Ctr | Los Angeles, California, 90095, United States
Children's Hosp of Oakland | Oakland, California, 946091809, United States
San Francisco Gen Hosp | San Francisco, California, 94110, United States
UCSF / Moffitt Hosp - Pediatric | San Francisco, California, 941430105, United States
Connecticut Children's Med Ctr | Farmington, Connecticut, 060303805, United States
Univ of Connecticut / Farmington | Farmington, Connecticut, 06032, United States
Yale Univ Med School | New Haven, Connecticut, 06504, United States
Children's Hosp of Washington DC | Washington, District of Columbia, 200102916, United States
Howard Univ. Washington DC NICHD CRS | Washington, District of Columbia, 20060, United States
North Broward Hosp District | Fort Lauderdale, Florida, 33311, United States
Univ of Florida Gainesville | Gainesville, Florida, 32610, United States
Univ of Florida Health Science Ctr / Pediatrics | Jacksonville, Florida, 32209, United States
Univ of Miami / Jackson Memorial Hosp | Miami, Florida, 33136, United States
Univ of Miami (Pediatric) | Miami, Florida, 33161, United States
Sacred Heart Children's Hosp / CMS of Florida | Pensacola, Florida, 32503, United States
Palm Beach County Health Dept | Riviera Beach, Florida, 33404, United States
Univ of South Florida | St. Petersburg, Florida, 33701, United States
Emory Univ Hosp / Pediatrics | Atlanta, Georgia, 30306, United States
Med College of Georgia | Augusta, Georgia, 30912, United States
The Med Ctr Inc | Columbus, Georgia, 31901, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics | Chicago, Illinois, 60608, United States
Cook County Hosp | Chicago, Illinois, 60612, United States
Univ of Illinois College of Medicine / Pediatrics | Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp | Chicago, Illinois, 606143394, United States
Univ of Chicago Children's Hosp | Chicago, Illinois, 606371470, United States
Children's Hospital of New Orleans | New Orleans, Louisiana, 70112-2699, United States
Tulane Univ / Charity Hosp of New Orleans | New Orleans, Louisiana, 701122699, United States
Earl K Long Early Intervention Clinic | New Orleans, Louisiana, 70112, United States
Univ Hosp | New Orleans, Louisiana, 70112, United States
Univ of Maryland at Baltimore / Univ Med Ctr | Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp - Pediatric | Baltimore, Maryland, 212874933, United States
Children's Hosp of Boston | Boston, Massachusetts, 021155724, United States
Childrens Hospital of Boston | Boston, Massachusetts, 02115, United States
Boston City Hosp / Pediatrics | Boston, Massachusetts, 02118, United States
Baystate Med Ctr of Springfield | Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med School | Worcester, Massachusetts, 016550001, United States
Children's Hosp of Michigan | Detroit, Michigan, 48201, United States
Univ of Mississippi Med Ctr | Jackson, Mississippi, 39213, United States
St. Louis Children's Hosp | St. Louis, Missouri, 63110, United States
Cooper Hosp | Camden, New Jersey, 081031438, United States
Robert Wood Johnson AIDS Program | New Brunswick, New Jersey, 08901-1969, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics | New Brunswick, New Jersey, 089030019, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark, New Jersey, 071032714, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | Newark, New Jersey, 07103, United States
Children's Hosp at Albany Med Ctr | Albany, New York, 12208, United States
Bronx Lebanon Hosp Ctr | Bronx, New York, 10457, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | Bronx, New York, 10461, United States
Montefiore Med Ctr Adolescent AIDS Program | Bronx, New York, 10467, United States
Montefiore Medical / AECOM | Bronx, New York, 19461, United States
SUNY - Brooklyn | Brooklyn, New York, 11203, United States
North Shore Univ Hosp | Great Neck, New York, 11021, United States
Schneider Children's Hosp | New Hyde Park, New York, 11040, United States
Beth Israel Med Ctr / Pediatrics | New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr | New York, New York, 10016, United States
Cornell Univ Med College | New York, New York, 10021, United States
New York Hosp - Cornell Med Ctr | New York, New York, 10021, United States
Metropolitan Hosp Ctr | New York, New York, 10029, United States
Mount Sinai Med Ctr / Pediatrics | New York, New York, 10029, United States
Columbia Presbyterian Med Ctr | New York, New York, 10032, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | New York, New York, 10032, United States
Harlem Hosp Ctr | New York, New York, 10037, United States
Univ of Rochester Med Ctr | Rochester, New York, 146420001, United States
State Univ of New York at Stony Brook | Stony Brook, New York, 117948111, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse, New York, 13210, United States
Duke Univ Med Ctr | Durham, North Carolina, 277103499, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr | Durham, North Carolina, 27710, United States
Columbus Children's Hosp | Columbus, Ohio, 432052696, United States
Oregon Health Sciences Univ | Portland, Oregon, 97201, United States
Children's Hosp of Philadelphia | Philadelphia, Pennsylvania, 191044318, United States
Saint Christopher's Hosp for Children | Philadelphia, Pennsylvania, 191341095, United States
Rhode Island Hosp / Brown Univ | Providence, Rhode Island, 02903, United States
Med Univ of South Carolina | Charleston, South Carolina, 294253312, United States
Saint Jude Children's Research Hosp of Memphis | Memphis, Tennessee, 381052794, United States
Vanderbilt Univ Med Ctr | Nashville, Tennessee, 372322581, United States
Children's Med Ctr of Dallas | Dallas, Texas, 75235, United States
Texas Children's Hosp / Baylor Univ | Houston, Texas, 77030, United States
Children's Hosp of the King's Daughters | Norfolk, Virginia, 23507, United States
Med College of Virginia | Richmond, Virginia, 23219, United States
Children's Hospital & Medical Center / Seattle ACTU | Seattle, Washington, 981050371, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics | Bayamon, 00956, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS | San Juan, 009365067, Puerto Rico
San Juan City Hosp | San Juan, 009367344, Puerto Rico
Ubicacion Paises

Puerto Rico

United States

Fecha de verificación

October 2013

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Fuente: ClinicalTrials.gov