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

NCT ID: NCT00162227

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2000-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection

Interventions

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Efavirenz

Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.

Intervention Type DRUG

Other Intervention Names

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Sustiva BMS-561525

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Phoenix, Arizona, United States

Site Status

Lac & Usc Medical Center

Los Angeles, California, United States

Site Status

Local Institution

Washington D.C., District of Columbia, United States

Site Status

Children'S Diagnostic Treatment Center

Fort Lauderdale, Florida, United States

Site Status

Arnold Palmer Hospital For Children And Woman

Orlando, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

The Children'S Memorial Hospital

Chicago, Illinois, United States

Site Status

University Of Chicago

Chicago, Illinois, United States

Site Status

Lsu Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Children'S Hospital

Boston, Massachusetts, United States

Site Status

University Of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

The Wellness Center

Las Vegas, Nevada, United States

Site Status

Umdnj - New Jersey Medical School

Newark, New Jersey, United States

Site Status

Schneider'S Childrens Hospital

New Hyde Park, New York, United States

Site Status

Office Of John Montana

New York, New York, United States

Site Status

St Luke'S-Roosevelt Hospital Center

New York, New York, United States

Site Status

Women And Childrens Care Center

New York, New York, United States

Site Status

Harlem Hospital Center

New York, New York, United States

Site Status

State University Of New York At Stony Brook

Stony Brook, New York, United States

Site Status

Suny Upstate Medical University

Syracuse, New York, United States

Site Status

Bronx Municipal Hospital Center

The Bronx, New York, United States

Site Status

Montefiore Medical Center/Aecom

The Bronx, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Metro Health Medical Center

Cleveland, Ohio, United States

Site Status

Local Institution

Youngstown, Ohio, United States

Site Status

St Jude Children'S Research Hospital

Memphis, Tennessee, United States

Site Status

Local Institution

Houston, Texas, United States

Site Status

Local Institution

Arecibo, , Puerto Rico

Site Status

Local Institution

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Related Links

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Other Identifiers

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AI266-913

Identifier Type: -

Identifier Source: org_study_id

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