A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
2 other identifiers
interventional
390
2 countries
68
Brief Summary
To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
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
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Erythropoietin.
- Concurrent Treatment:
- Allowed:
- Transfusion.
- Patients must have:
- Progressive HIV disease.
- At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active malignancy requiring chemotherapy.
- Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study.
- Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study.
- Concurrent Medication:
- Excluded (unless exemption made by study chair):
- Oral anticoagulants (warfarin, dicumarol).
- Oral contraceptives.
- Digitalis glycosides.
- Phenytoin.
- Theophylline.
- Patients with the following prior conditions are excluded:
- History of clinical pancreatitis.
- History of grade 2 or worse peripheral neuropathy.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294, 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
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752, 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
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032, United States
Yale Univ Med School
New Haven, Connecticut, 06504, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, 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
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
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
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019, 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
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203, 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
Beth Israel Med Ctr / Pediatrics
New York, New York, 10003, 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
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York, New York, 10029, United States
Mount Sinai Med Ctr / Pediatrics
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 Medical Center
Rochester, New York, 14642, 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
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
The Bronx, New York, 10461, United States
Westchester Hosp
Valhalla, New York, 10595, 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
West Central Ohio Hemophilia Ctr / Children's Med Ctr
Dayton, Ohio, 454041815, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Univ of Pittsburgh Med School / Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095, United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, 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 (4)
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
BACKGROUNDBurchett SK, Carey V, Yong F, Sullivan J, Sulzbacher S, Civitello L, Culnane M, Mofenson L, Siminski S, Robinson P, Luzuriaga K. Virologic activity of didanosine (ddI), zidovudine (ZDV) and nevirapine (NVP) combinations in pediatric subjects with advanced HIV disease (ACTG 245). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:130 (abstract no 271)
BACKGROUNDPerrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
PMID: 21037891BACKGROUNDBurchett S, Sullivan J, Luzuriaga K, Carey V, Yong F, Culnane M, Mofenson L, Robinson P. Combinations of didanosine (DDI), zidovudine (ZDV) and nevirapine (NVP) can reduce CSF HIV-1 viral load in pediatric patients with advanced HIV disease. Int Conf AIDS. 1998;12:62 (abstract no 12253)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Burchett S
- STUDY CHAIR
Luzuriaga K