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
2 other identifiers
observational
120
2 countries
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedApril 26, 2010
November 1, 2005
November 2, 1999
April 23, 2010
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
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
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
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805, United States
Howard Univ Hosp
Washington D.C., 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 (Pediatric)
Miami, Florida, 33161, United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, 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
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, 70112, United States
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
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213, 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
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
Harlem Hosp Ctr
New York, New York, 10037, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794, 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
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 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
Related Publications (5)
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)
BACKGROUNDWu 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.
PMID: 14767811RESULTFlynn 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.
PMID: 15216461RESULTRudy 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.
PMID: 16545007RESULTFlynn 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.
PMID: 17961106RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Patricia Flynn