A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
RAD-1: A Phase I/II Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience
2 other identifiers
interventional
217
2 countries
62
Brief Summary
The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment. Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
62 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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Your child may be eligible for this study if he or she:
- Is HIV-positive.
- Is between the ages of 6 months and 21 years (consent of parent or guardian required if under 18).
- Has an HIV blood level above 50,000 copies/mL on 2 consecutive occasions, while taking anti-HIV therapy.
- Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy.
- Is able to receive at least one of the following: RTV, NVP, or NFV.
You may not qualify if:
- Your child will not be eligible for this study if he or she:
- Is receiving treatment for a serious bacterial, viral, or opportunistic (HIV-associated) infection within 14 days prior to study entry.
- Has a history of pancreatitis or peripheral neuropathy.
- Has cancer requiring chemotherapy.
- Is allergic to the study medications.
- Is taking certain medications.
- Is pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
Univ of South Alabama
Mobile, Alabama, 36604, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, 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
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
Children's Hosp of Oakland
Oakland, California, 946091809, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805, United States
Yale Univ Med School
New Haven, Connecticut, 06504, 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 Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, 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
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
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, 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
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
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213, 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
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
Cornell Univ Med College
New York, New York, 10021, United States
Metropolitan Hosp Ctr
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
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, 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
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095, 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
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 (7)
Weinberg A, Kovacs A, Pahwa S, Carey V, Oyomopito R, Mofenson L, Khoury M, Zimmer B, Burchett S. HIV-infected children on HAART reconstitute tetanus-specific T cell responses without booster vaccination. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 688)
BACKGROUNDFrenkel LM, Burchett SK, Aldrovandi GM, Carey V, Oyomopito R, Mahalanibis M, Decker D, Kovacs A. HIV-1 reverse transcriptase (RT) M184V/I improves the rate of suppression of viral replication by salvage therapy. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 463)
BACKGROUNDKovacs A, Burchett S, Khoury M, Carey V, Pahwa S, McIntosh K, Oyomopito R, Smith E, Mofenson L. Virologic and immunologic responses in children with advanced HIV disease on a new HAART regimen (PACTG 366). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 684)
BACKGROUNDWeinberg A, Pahwa S, Oyomopito R, Carey VJ, Zimmer B, Mofenson L, Kovacs A, Burchett SK; Pediatric AIDS Clinical Trials Group 366 Team. Antimicrobial-specific cell-mediated immune reconstitution in children with advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy. Clin Infect Dis. 2004 Jul 1;39(1):107-14. doi: 10.1086/420931. Epub 2004 Jun 14.
PMID: 15206061BACKGROUNDSaitoh A, Sarles E, Capparelli E, Aweeka F, Kovacs A, Burchett SK, Wiznia A, Nachman S, Fenton T, Spector SA. CYP2B6 genetic variants are associated with nevirapine pharmacokinetics and clinical response in HIV-1-infected children. AIDS. 2007 Oct 18;21(16):2191-9. doi: 10.1097/QAD.0b013e3282ef9695.
PMID: 18090046RESULTEV Capparelli, SK Burchett, A Kovacs, M Khoury, R Oyomopito, L Mofenson, B Zimmer, D Holland. Characterization of the Ritonavir-Nelfinavir Pharmacokinetic Interaction in Pediatric Patients with Advanced HIV Disease Using a Mixed Effects Modeling Approach, Pharmacotherapy, (2003), Abstract 67, Vol.23, No.3, pp.401.
RESULTS. Burchett, M. Khoury, K. McIntosh, V. Carey, R. Oyomopito, L. Mofenson, E. Smith, A. Kovacs, Viral Load Reduction in Children with Advanced HIV Disease Treated with 4-Drug Antiretroviral Treatment Regimens Including NRTIs, Nevirapine, Nelfinavir and/or Ritonavir, CROI, 2000.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrea Kovacs
- STUDY CHAIR
Sandra Burchett