This study will evaluate T-20 in children.
Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Children's Hosp Los Angeles
Los Angeles, California, United States
Univ of Florida Gainesville
Gainesville, Florida, United States
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, United States
Mount Sinai Hosp
New York, New York, United States
Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)
The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated.
Time frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
Number of Participants With Adverse Events (AEs) and Serious AEs
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.
Time frame: Up to Week 4 after discontinuation of therapy
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities
Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively.
Time frame: Up to Week 96
Number of Participants Who Died
Time frame: Up to Week 96
Number of Participants Who Prematurely Withdrew Due to AE
Time frame: Up to Week 96
Number of Participants With Worst Local Injection Site Reactions
Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded.
Time frame: Up to Week 96