NCT00162188

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2001

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

9.6 years

First QC Date

September 9, 2005

Last Update Submit

January 8, 2014

Conditions

HIV Infection

Interventions

EfavirenzDRUG

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

Also known as: Sustiva, BMS-561525

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Local Institution

Edmonton, Alberta, T6G 2J3, Canada

Location

Local Institution

Vancouver, British Columbia, V6H 3N1, Canada

Location

Local Institution

Toronto, Ontario, M5G 1X8, Canada

Location

Local Institution

Montreal, Quebec, H3T 1C5, Canada

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bristol Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

May 1, 2001

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

CA(4)