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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Conditions

HIV Infection

Treatments

Drug: Efavirenz

Study type

Expanded Access

Funder types

Industry

Identifiers

NCT00162188
AI266-914

Details and patient eligibility

About

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.

Sex

All

Ages

3 to 16 years old

Volunteers

No 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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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