- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00001097
Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems
Establishment and Maintenance of Long-Term Undetectable Plasma HIV-1 RNA: Correlation With Immunologic Reconstitution and Viral Dynamics
The purpose of this study is to see if children and young adults with better immune systems before starting highly active antiretroviral therapy (HAART) do better than those who have weaker immune systems before starting HAART.
HIV infection weakens the immune system's ability to fight other infections and diseases. HAART is a type of anti-HIV therapy shown to improve the immune system of adults. However, not all patients show the same amount of improvement with HAART. Doctors believe that results may depend on how strong a patient's immune system is before starting HAART. Long-term effects of HAART in children and young adults have not yet been studied.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung
Kontakte und Standorte
Studienorte
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Bayamon, Puerto Rico, 00956
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
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San Juan, Puerto Rico, 009367344
- San Juan City Hosp
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35233
- Univ of Alabama at Birmingham - Pediatric
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Mobile, Alabama, Vereinigte Staaten, 36604
- Univ of South Alabama
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85006
- Phoenix Childrens Hosp
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California
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La Jolla, California, Vereinigte Staaten, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
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Los Angeles, California, Vereinigte Staaten, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, Vereinigte Staaten, 90033
- Los Angeles County - USC Med Ctr
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Los Angeles, California, Vereinigte Staaten, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Colorado
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Denver, Colorado, Vereinigte Staaten, 802181088
- Children's Hosp of Denver
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Connecticut
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Farmington, Connecticut, Vereinigte Staaten, 060303805
- Connecticut Children's Med Ctr
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20060
- Howard Univ Hosp
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Florida
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Fort Lauderdale, Florida, Vereinigte Staaten, 33311
- North Broward Hosp District
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Gainesville, Florida, Vereinigte Staaten, 32610
- Univ of Florida Gainesville
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Jacksonville, Florida, Vereinigte Staaten, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, Vereinigte Staaten, 33161
- Univ of Miami (Pediatric)
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Riviera Beach, Florida, Vereinigte Staaten, 33404
- Palm Beach County Health Dept
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30306
- Emory Univ Hosp / Pediatrics
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Cook County Hosp
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Chicago, Illinois, Vereinigte Staaten, 606143394
- Chicago Children's Memorial Hosp
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Chicago, Illinois, Vereinigte Staaten, 606371470
- Univ of Chicago Children's Hosp
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Chicago, Illinois, Vereinigte Staaten, 60612
- Univ of Illinois College of Medicine / Pediatrics
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Earl K Long Early Intervention Clinic
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 021155724
- Children's Hosp of Boston
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Boston, Massachusetts, Vereinigte Staaten, 02118
- Boston City Hosp / Pediatrics
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Springfield, Massachusetts, Vereinigte Staaten, 01199
- Baystate Med Ctr of Springfield
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48201
- Children's Hosp of Michigan
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Mississippi
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Jackson, Mississippi, Vereinigte Staaten, 39213
- Univ of Mississippi Med Ctr
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New York
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Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Med Ctr Adolescent AIDS Program
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Bronx, New York, Vereinigte Staaten, 10457
- Bronx Lebanon Hosp Ctr
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Brooklyn, New York, Vereinigte Staaten, 11203
- SUNY - Brooklyn
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Great Neck, New York, Vereinigte Staaten, 11021
- North Shore Univ Hosp
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New Hyde Park, New York, Vereinigte Staaten, 11040
- Schneider Children's Hosp
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New York, New York, Vereinigte Staaten, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Vereinigte Staaten, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, Vereinigte Staaten, 10032
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
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New York, New York, Vereinigte Staaten, 10037
- Harlem Hosp Ctr
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Syracuse, New York, Vereinigte Staaten, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 277103499
- Duke Univ Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 191044318
- Children's Hosp of Philadelphia
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Tennessee
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Memphis, Tennessee, Vereinigte Staaten, 381052794
- Saint Jude Children's Research Hosp of Memphis
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Texas
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Dallas, Texas, Vereinigte Staaten, 75235
- Children's Med Ctr of Dallas
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Houston, Texas, Vereinigte Staaten, 77030
- Texas Children's Hosp / Baylor Univ
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Virginia
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Norfolk, Virginia, Vereinigte Staaten, 23507
- Children's Hosp of the King's Daughters
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Washington
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Seattle, Washington, Vereinigte Staaten, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
Children may be eligible for this study if they:
- Are HIV-positive.
- Are between 8 and 22 years old (consent of parent or guardian required if under 18).
- Have detectable levels of HIV in the blood within 30 days prior to study entry.
- Expect to be on the study for at least 1 year. (This study has been changed by adding this requirement.)
- Are pregnant and are not taking didanosine/stavudine (ddI/d4T) or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients may be eligible if they are not taking ddI/d4T or EFV.)
Exclusion Criteria
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.)
Studienplan
Wie ist die Studie aufgebaut?
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Patricia Flynn
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Flynn P, Douglas S, Rudy B, Lathey J, Lindsey J, Wang Y. Establishment and maintenance of long-term undetectable plasma HIV-1 RNA: correlation with immunologic reconstitution and viral dynamics. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 692)
- Wu H, Lathey J, Ruan P, Douglas SD, Spector SA, Lindsey J, Hughes MD, Rudy BJ, Flynn PM; PACTG 381 Team. Relationship of plasma HIV-1 RNA dynamics to baseline factors and virological responses to highly active antiretroviral therapy in adolescents (aged 12-22 years) infected through high-risk behavior. J Infect Dis. 2004 Feb 15;189(4):593-601. doi: 10.1086/381500. Epub 2004 Jan 29.
- Flynn PM, Rudy BJ, Douglas SD, Lathey J, Spector SA, Martinez J, Silio M, Belzer M, Friedman L, D'Angelo L, McNamara J, Hodge J, Hughes MD, Lindsey JC; Pediatric AIDS Clinical Trial Group 381 Study Team. Virologic and immunologic outcomes after 24 weeks in HIV type 1-infected adolescents receiving highly active antiretroviral therapy. J Infect Dis. 2004 Jul 15;190(2):271-9. doi: 10.1086/421521. Epub 2004 Jun 18.
- Rudy BJ, Lindsey JC, Flynn PM, Bosch RJ, Wilson CM, Hughes ME, Douglas SD; Pediatric Aids Clinical Trials Group 381 Study Team. Immune reconstitution and predictors of virologic failure in adolescents infected through risk behaviors and initiating HAART: week 60 results from the PACTG 381 cohort. AIDS Res Hum Retroviruses. 2006 Mar;22(3):213-21. doi: 10.1089/aid.2006.22.213.
- Flynn PM, Rudy BJ, Lindsey JC, Douglas SD, Lathey J, Spector SA, Martinez J, Silio M, Belzer M, Friedman L, D'Angelo L, Smith E, Hodge J, Hughes MD; PACTG 381 Study Team. Long-term observation of adolescents initiating HAART therapy: three-year follow-up. AIDS Res Hum Retroviruses. 2007 Oct;23(10):1208-14. doi: 10.1089/aid.2006.0290.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- ACTG 381
- PACTG 381
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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