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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022763
• Other study ID #: NV16056
• Secondary ID: T20-310295E
• Status: Completed
• Phase: Phase 2
• First received: August 11, 2001
• Last updated: January 19, 2016
• Start date: August 2001

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate T-20 in children.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Enfuvirtide

Locations

Country	Name	City	State
United States	Bronx Lebanon Hosp Ctr	Bronx	New York
United States	Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Bronx	New York
United States	Univ of Florida Gainesville	Gainesville	Florida
United States	Children's Hosp Los Angeles	Los Angeles	California
United States	Mount Sinai Hosp	New York	New York
United States	New York Hosp - Cornell / Program for Children with AIDS	New York	New York
United States	Children's Hosp of the King's Daughters	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Participants Who Died		Up to Week 96	No
Secondary	Number of Participants Who Prematurely Withdrew Due to AE		Up to Week 96	No
Secondary	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	No