Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

HIV Infection

Eligibility:

All Genders

3-16 years

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 ag...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2000

Trial Type :

EXPANDED_ACCESS

End Date :

December 1 2010

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00162227

Start Date

September 1 2000

End Date

December 1 2010

Last Update

January 9 2014

Active Locations (29)

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Page 1 of 8 (29 locations)

1

Local Institution

Phoenix, Arizona, United States, 85016

2

Lac & Usc Medical Center

Los Angeles, California, United States, 90033

3

Local Institution

Washington D.C., District of Columbia, United States, 20010

4

Children'S Diagnostic Treatment Center

Fort Lauderdale, Florida, United States, 33301