Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children.
Joseph A Church, Coleen Cunningham, Michael Hughes...
https://pubmed.ncbi.nlm.nih.gov/12237598Completed
Phase 1
Age: 3Years - 12Years
All Genders
ID00001118
A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-01
24
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children. T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).
CONDITIONS
Official Title
Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
Who Can Participate
Age: 3Years - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Children may be eligible for this study if they:
- Are 3 to 12 years old (consent of parent or guardian required).
- Are HIV-positive.
- Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)
- Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.
- Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)
- Have never taken at least 1 NRTI.
Exclusion Criteria
Children will not be eligible for this study if they:
- Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.
- Are receiving chemotherapy for cancer.
- Have certain serious diseases (other than HIV) or conditions.
- Have received or are currently receiving certain medications.
- Are pregnant.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 25 locations
1
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Status Unknown
2
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Status Unknown
3
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Status Unknown
4
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Status Unknown
5
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States, 200102916
Status Unknown
6
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
7
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
8
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
9
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
10
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
11
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Status Unknown
12
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
13
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
Status Unknown
14
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
Status Unknown
15
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
16
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
17
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
18
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Status Unknown
19
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
20
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Status Unknown
21
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10457
Status Unknown
22
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
23
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Status Unknown
24
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
25
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Population pharmacokinetics of enfuvirtide in pediatric patients with human immunodeficiency virus: searching for exposure-response relationships.
Dolors Soy, Francesca T Aweeka, Joseph A Church...
https://pubmed.ncbi.nlm.nih.gov/14663459Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children.
Joseph A Church, Michael Hughes, Jie Chen...
https://pubmed.ncbi.nlm.nih.gov/15295220