T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents

This study will evaluate T-20 in children.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Enfuvirtide

Detailed Description

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
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hosp Los Angeles
  • Florida
    • Gainesville, Florida, United States, 32610
      • Univ of Florida Gainesville
  • New York
    • Bronx, New York, United States, 10461
      • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
    • Bronx, New York, United States, 10457
      • Bronx Lebanon Hosp Ctr
    • New York, New York, United States, 10021
      • New York Hosp - Cornell / Program for Children with AIDS
    • New York, New York, United States, 10029
      • Mount Sinai Hosp
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Children's Hosp of the King's Daughters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

• Are 3 through 16 years of age and have the consent of parent or guardian.
• Have a viral load of at least 5000 copies/ml.
• Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
• Have been on stable therapy for at least 4 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
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.	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.	Up to Week 96
Number of Participants Who Died		Up to Week 96
Number of Participants Who Prematurely Withdrew Due to AE		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.	Up to Week 96

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Trimeris

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: August 11, 2001
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): February 15, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Anti-HIV Agents; pentafuside
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Enfuvirtide
• Other Study ID Numbers: NV16056; T20-310; 295E