NCT00022763

Brief Summary

This study will evaluate T-20 in children.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2001

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
11.2 years until next milestone

Results Posted

Study results publicly available

February 15, 2016

Completed
Last Updated

February 15, 2016

Status Verified

January 1, 2016

Enrollment Period

3.3 years

First QC Date

August 11, 2001

Results QC Date

December 4, 2015

Last Update Submit

January 19, 2016

Conditions

HIV Infections

Keywords

Anti-HIV Agentspentafuside

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)

    Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

  • Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide

    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)

    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)

    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

    Up to Week 4 after discontinuation of therapy

  • +4 more secondary outcomes

Interventions

EnfuvirtideDRUG

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Children's Hosp Los Angeles

Los Angeles, California, 90027, United States

Location

Univ of Florida Gainesville

Gainesville, Florida, 32610, United States

Location

New York Hosp - Cornell / Program for Children with AIDS

New York, New York, 10021, United States

Location

Mount Sinai Hosp

New York, New York, 10029, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10457, United States

Location

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

The Bronx, New York, 10461, United States

Location

Children's Hosp of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2001

First Posted

August 31, 2001

Study Start

August 1, 2001

Primary Completion

December 1, 2004

Last Updated

February 15, 2016

Results First Posted

February 15, 2016

Record last verified: 2016-01

Locations

US(7)