Clinical trial NCT00022763: T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Anti-HIV Agents
pentafuside
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Trimeris
First posted: 2001-08-31
Enrollment: 52
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate T-20 in children.

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 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.

Primary outcomes:
measure: Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)
timeFrame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)
timeFrame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
measure: Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide
timeFrame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
measure: Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)
timeFrame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
measure: AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)
timeFrame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
measure: Number of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: Up to Week 4 after discontinuation of therapy
measure: Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities
timeFrame: Up to Week 96
measure: Number of Participants Who Died
timeFrame: Up to Week 96
measure: Number of Participants Who Prematurely Withdrew Due to AE
timeFrame: Up to Week 96
measure: Number of Participants With Worst Local Injection Site Reactions
timeFrame: Up to Week 96
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hosp Los Angeles
state: California
city: Gainesville
country: United States
facility: Univ of Florida Gainesville
state: Florida
city: Bronx
country: United States
facility: Bronx Lebanon Hosp Ctr
state: New York
city: Bronx
country: United States
facility: Bronx Municipal Hosp Ctr/Jacobi Med Ctr
state: New York
city: New York
country: United States
facility: New York Hosp - Cornell / Program for Children with AIDS
state: New York
city: New York
country: United States
facility: Mount Sinai Hosp
state: New York
city: Norfolk
country: United States
facility: Children's Hosp of the King's Daughters
state: Virginia
Study officials:
References: