Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection
Early Intensive Antiretroviral Combination Therapy in HIV-1 Infected Infants and Children
3 other identifiers
interventional
55
1 country
12
Brief Summary
This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
12 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
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
January 1, 2005
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Antiretroviral activity of ZDV/3TC/NVP
Throughout study
Durability of viral suppression
Throughout study
Immune competence and HIV-1 specific immune respones with prolonged viral suppression beyond 104 weeks
Throughout study
Antiretroviral activity of ZDV/3TC/NVP/1592U89 regimen
Throughout study
Antiretroviral activity of d4T/3TC/NVP/NFV regimen
Throughout study
Tolerance and pharmacokinetic profile of NFV
Throughout study
Interventions
Eligibility Criteria
You may qualify if:
- Children may be eligible for this study if they:
- Are 15 days to 2 years old.
- Have consent of parent or legal guardian.
- Are HIV-positive.
You may not qualify if:
- Children will not be eligible for this study if they:
- Have certain infections which require treatment during the study.
- Have received certain medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, 32209, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 701122699, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 212874933, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 016550001, United States
Univ. of Mississippi Med. Ctr Children's Hosp.
Detroit, Michigan, United States
Nyu Ny Nichd Crs
New York, New York, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 191044318, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
Children's Hosp. of the King's Daughters, Infectious Disease
Norfolk, Virginia, 23507, United States
Related Publications (7)
Luzuriaga K, McManus M, Britto P, Wu HL, Lindsey J, Sullivan JL. Viral kinetics and control of replication following potent early combination antiretroviral therapy of vertical HIV-1 infection. HIV Pathog Treat Conf. 1998 Mar 13-19;52 (abstract no 2024)
BACKGROUNDCapparelli E, Sullivan J, Mofenson L, Smith B, Graham B, Britto P, Becker M, Luzuriaga K. Pharmacokinetics (PK) of nelfinavir and its metabolite (M8) in HIV-infected infants following BID or TID administration. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 729)
BACKGROUNDLuzuriaga K, Wu H, McManus M, Britto P, Borkowsky W, Burchett S, Smith B, Mofenson L, Sullivan JL. Dynamics of human immunodeficiency virus type 1 replication in vertically infected infants. J Virol. 1999 Jan;73(1):362-7. doi: 10.1128/JVI.73.1.362-367.1999.
PMID: 9847340BACKGROUNDLuzuriaga K, Mcmanus M, Britto P, Wu H, Lindsey J, Smith B, Mofenson L, Sullivan JL. Early combination antiretroviral therapy of vertical HIV-1 infection: viral kinetics and control of viral replication. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:225 (abstract no LB12)
BACKGROUNDCapparelli EV, Sullivan JL, Mofenson L, Smith E, Graham B, Britto P, Becker MI, Holland D, Connor JD, Luzuriaga K; Pediatric ACTG 356 Investigators. Pharmacokinetics of nelfinavir in human immunodeficiency virus-infected infants. Pediatr Infect Dis J. 2001 Aug;20(8):746-51. doi: 10.1097/00006454-200108000-00006.
PMID: 11734735BACKGROUNDLuzuriaga K, McManus M, Mofenson L, Britto P, Graham B, Sullivan JL; PACTG 356 Investigators. A trial of three antiretroviral regimens in HIV-1-infected children. N Engl J Med. 2004 Jun 10;350(24):2471-80. doi: 10.1056/NEJMoa032706.
PMID: 15190139BACKGROUNDMcManus M, Henderson J, Gautam A, Brody R, Weiss ER, Persaud D, Mick E, Luzuriaga K; PACTG 356 Investigators. Quantitative Human Immunodeficiency Virus (HIV)-1 Antibodies Correlate With Plasma HIV-1 RNA and Cell-associated DNA Levels in Children on Antiretroviral Therapy. Clin Infect Dis. 2019 May 2;68(10):1725-1732. doi: 10.1093/cid/ciy753.
PMID: 30668843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Katherine Luzuriaga
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
January 1, 2005
Last Updated
November 4, 2021
Record last verified: 2021-10