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Ensayos clínicos

Ensayos clínicos

Long-Term Effects of HAART in Youth with Stronger Immune Systems Versus Youth with Weaker Immune Systems

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001097, ACTG 381
  • Concluido

Propósito del estudio

To determine if a positive correlation exists between the baseline immunologic status and the virologic and immunologic responses to highly active antiretroviral therapy (HAART) at 1, 2, and 3 years after initiation of treatment.

Afección:
Infecciones por el VIH

Detalles del estudio

Recent adult clinical trials involving combination HAART, including a protease inhibitor (PI), have demonstrated improvements in somatic immune system functioning. [AS PER AMENDMENT 2/27/01: More recently, similar success has been demonstrated with a PI-sparing regimen, zidovudine, lamivudine, and efavirenz.] Not all individuals, however, experience the same level of immune reconstitution, and oftentimes any improvement is short-lived. Adolescent patients may have a greater potential for immune restoration because of residual thymic tissue and therefore may experience greater long-term virus-free states as compared to adult patients. This study examines the duration of virologic efficacy HAART has on the adolescent HIV-positive population.Patients begin study by initiating a HAART regimen of a minimum of 3 drugs, at least 1 of which must be a PI [AS PER AMENDMENT 2/27/01: or efavirenz (EFV)]. A variety of drug combinations are used; therefore, patients are grouped according to the classes of drugs in their respective regimen (e.g., 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus 1 PI; 2 NRTIs plus 2 PIs; 1 or 2 NRTIs plus 1 PI plus 1 nonnucleoside reverse transcriptase inhibitor [NNRTI] [AS PER AMENDMENT 2/27/01: ; and 2 NRTIs plus EFV]). At the time of HAART initiation, patients undergo immunologic and virologic assessments in order to determine baseline values. Then, to determine the virologic success or failure of HAART, HIV-1 RNA measurements are taken and compared to initial baseline values. Virologic success equals undetectable HIV-1 RNA at Week 12 [AS PER AMENDMENT 2/27/01: and confirmed at Week 16] or a significant (greater than 1 log) decrease in HIV-1 RNA from baseline to Week 12 [AS PER AMENDMENT 2/27/01: and confirmed undetectable HIV-1 RNA before the next scheduled visit (Week 24)]. Patients are followed for a minimum of 3 years of maintained viral suppression or until they have demonstrated virologic failure. From these values, any correlation that may exist between HIV-1 RNA values and HAART can be deduced. Patients with virologic failure on the initial HAART regimen may be allowed to change to a second HAART regimen. [AS PER AMENDMENT 2/27/01: Patients with virologic success on the second HAART regimen are followed for a minimum of 3 years.] Patients with virologic failure on the second HAART regimen or who voluntarily discontinue HAART are followed using an abbreviated schedule for 3 years.

Criterios de exclusión

    Children will not be eligible for this study if they: Are taking HAART or more than 1 anti-HIV drug. Were infected with HIV before birth, at the time of delivery, or by a blood transfusion during birth. Have taken part in the study before. Have not responded well to HAART in the past. Have taken drugs to boost the immune system such as HIV vaccines, IVIG, or cytokine therapy. Have AIDS-related (opportunistic) infection at the time of screening. (This study has been changed so that patients with an AIDS-related infection are ineligible.) Are pregnant and are taking ddI/d4T or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients are ineligible if they are taking ddI/d4T or EFV.)

Centros de estudio/contactos

Alabama

    Univ of Alabama at Birmingham - Pediatric, Birmingham, Alabama, 35233, United States

    Univ of South Alabama, Mobile, Alabama, 36604, United States

Arizona

    Phoenix Childrens Hosp, Phoenix, Arizona, 85006, United States

California

    UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States

    Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California, 905022004, 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

Colorado

    Children's Hosp of Denver, Denver, Colorado, 802181088, United States

Connecticut

    Connecticut Children's Med Ctr, Farmington, Connecticut, 060303805, United States

District of Columbia

    Howard Univ Hosp, Washington, District of Columbia, 20060, United States

Florida

    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 (Pediatric), Miami, Florida, 33161, United States

    Palm Beach County Health Dept, Riviera Beach, Florida, 33404, United States

Georgia

    Emory Univ Hosp / Pediatrics, Atlanta, Georgia, 30306, United States

Illinois

    Chicago Children's Memorial Hosp, Chicago, Illinois, 606143394, United States

    Cook County Hosp, Chicago, Illinois, 60612, United States

    Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois, 60612, United States

    Univ of Chicago Children's Hosp, Chicago, Illinois, 606371470, United States

Louisiana

    Earl K Long Early Intervention Clinic, New Orleans, Louisiana, 70112, United States

Massachusetts

    Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States

    Boston City Hosp / Pediatrics, Boston, Massachusetts, 02118, United States

    Baystate Med Ctr of Springfield, Springfield, Massachusetts, 01199, United States

Michigan

    Children's Hosp of Michigan, Detroit, Michigan, 48201, United States

Mississippi

    Univ of Mississippi Med Ctr, Jackson, Mississippi, 39213, United States

New York

    Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York, 10467, United States

    Bronx Lebanon Hosp Ctr, Bronx, New York, 10457, 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

    Harlem Hosp Ctr, New York, New York, 10037, United States

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, 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

    SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York, 13210, United States

North Carolina

    Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States

Pennsylvania

    Children's Hosp of Philadelphia, Philadelphia, Pennsylvania, 191044318, United States

Tennessee

    Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee, 381052794, United States

Texas

    Children's Med Ctr of Dallas, Dallas, Texas, 75235, United States

    Texas Children's Hosp / Baylor Univ, Houston, Texas, 77030, United States

Virginia

    Children's Hosp of the King's Daughters, Norfolk, Virginia, 23507, United States

Washington

    Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington, 981050371, United States

    Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon, Washington, 00956, Puerto Rico

    San Juan City Hosp, San Juan, Washington, 009367344, Puerto Rico

    Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan, Washington, 009365067, Puerto Rico

Actualizado: 9 de noviembre del 2004

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