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

Primary Purpose

HIV Infection

Status

No longer available

Phase

Locations

Canada

Study Type

Expanded Access

Intervention

Efavirenz

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 (ARV) regimen Limited available viable therapeutic options Inability to take capsules/tablets Exclusion Criteria: Weighs less than 10 kg Failure on or concomitant use of other non-nucleoside reverse transcriptase inhibitors (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
Local Institution
Local Institution
Local Institution

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00162188

First Posted

September 9, 2005

Last Updated

January 8, 2014

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00162188

Brief Title

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

Official Title

Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)

Study Type

Expanded Access

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

No longer available

Study Start Date

May 2001 (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 of 3-16 who are failing or intolerant of their 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

Eligibility Criteria

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

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2J3

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3N1

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

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: Canada

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