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An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection

Primary Purpose

HIV Infection

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Efavirenz
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for HIV Infection

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children 3-16 years of age Anti-retroviral naive or experienced Failing or intolerant to current Anti-retroviral regimen Limited available viable therapeutic options Inability to take capsules/tablets Exclusion Criteria: Less than 10kg Failure on or concomitant use of other NNRTIs An active AIDS-defining opportunistic infection or disease More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months

Sites / Locations

  • Local Institution
  • Lac & Usc Medical Center
  • Local Institution
  • Children'S Diagnostic Treatment Center
  • Arnold Palmer Hospital For Children And Woman
  • Cleveland Clinic Florida
  • The Children'S Memorial Hospital
  • University Of Chicago
  • Lsu Health Sciences Center
  • Children'S Hospital
  • University Of Massachusetts Medical School
  • The Wellness Center
  • Umdnj - New Jersey Medical School
  • Bronx Municipal Hospital Center
  • Montefiore Medical Center/Aecom
  • Schneider'S Childrens Hospital
  • Office Of John Montana
  • St Luke'S-Roosevelt Hospital Center
  • Women And Childrens Care Center
  • Harlem Hospital Center
  • State University Of New York At Stony Brook
  • Suny Upstate Medical University
  • New York Medical College
  • Metro Health Medical Center
  • Local Institution
  • St Jude Children'S Research Hospital
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
January 8, 2014
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00162227
Brief Title
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
Official Title
US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)
Study Type
Expanded Access

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
No longer available
Study Start Date
September 2000 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages 3-16 who are failing or intolerant of current antiretroviral regimen and who are unable to swallow Sustiva capsules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Efavirenz
Other Intervention Name(s)
Sustiva, BMS-561525
Intervention Description
Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 3-16 years of age Anti-retroviral naive or experienced Failing or intolerant to current Anti-retroviral regimen Limited available viable therapeutic options Inability to take capsules/tablets Exclusion Criteria: Less than 10kg Failure on or concomitant use of other NNRTIs An active AIDS-defining opportunistic infection or disease More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Lac & Usc Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children'S Diagnostic Treatment Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
Arnold Palmer Hospital For Children And Woman
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
The Children'S Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Lsu Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Children'S Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University Of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
The Wellness Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Umdnj - New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx Municipal Hospital Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center/Aecom
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Schneider'S Childrens Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Office Of John Montana
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St Luke'S-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Women And Childrens Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
State University Of New York At Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Suny Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Metro Health Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Local Institution
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44502
Country
United States
Facility Name
St Jude Children'S Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection

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