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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 11, 2001
Last updated: January 19, 2016
Last verified: January 2016
This study will evaluate T-20 in children.

Condition Intervention Phase
HIV Infections
Drug: Enfuvirtide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
    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.

Secondary Outcome Measures:
  • Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
    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 to Maximum Plasma Concentration (Tmax) for Enfuvirtide [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
    Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  • Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
    Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.

  • AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
    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.

  • Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Up to Week 4 after discontinuation of therapy ]
    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.

  • Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities [ Time Frame: Up to Week 96 ]
    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.

  • 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 [ Time Frame: Up to Week 96 ]
    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.

Enrollment: 52
Study Start Date: August 2001
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00022763

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00022763     History of Changes
Other Study ID Numbers: NV16056
Study First Received: August 11, 2001
Results First Received: December 4, 2015
Last Updated: January 19, 2016

Keywords provided by Hoffmann-La Roche:
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on May 25, 2017