Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems
NCT ID: NCT00001097
Last Updated: 2010-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
1997-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
8 Years
22 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Patricia Flynn
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Univ of South Alabama
Mobile, Alabama, United States
Phoenix Childrens Hosp
Phoenix, Arizona, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Connecticut Children's Med Ctr
Farmington, Connecticut, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Univ of Florida Gainesville
Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Palm Beach County Health Dept
Riviera Beach, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
SUNY - Brooklyn
Brooklyn, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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PACTG 381
Identifier Type: -
Identifier Source: secondary_id
ACTG 381
Identifier Type: -
Identifier Source: org_study_id
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