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

Purpose

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 Endpoint Classification: Safety Study 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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Number of Participants Who Prematurely Withdrew Due to AE [ Time Frame: Up to Week 96 ] [ Designated as safety issue: No ]
Number of Participants With Worst Local Injection Site Reactions [ Time Frame: Up to Week 96 ] [ Designated as safety issue: No ]
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.

Eligibility


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

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022763

Locations


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

Trimeris

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00022763 History of Changes
Other Study ID Numbers:	NV16056 T20-310 295E
Study First Received:	August 11, 2001
Results First Received:	December 4, 2015
Last Updated:	January 19, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:


Anti-HIV Agents pentafuside

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	Enfuvirtide HIV Fusion Inhibitors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 26, 2016