HIV InfectionNCT00162188
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada
A study testing Efavirenz in people with HIV Infection, run by Bristol-Myers Squibb at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Efavirenz
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 4 sitesCanada
- Study dates
- May 2001to Dec 2010
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Canada4 sites
Local Institution
Edmonton, Alberta, T6G 2J3
Local Institution
Montreal, Quebec, H3T 1C5
Local Institution
Toronto, Ontario, M5G 1X8
Local Institution
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)
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.
- Conditions
- HIV Infection
- Being tested
- Efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
Also called Sustiva, BMS-561525
Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2001
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162188
- Sponsor's protocol ID
- AI266-914
- Status last verified
- Jan 2014
- First submitted
- 9 Sep 2005
- Last updated
- 9 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Sustiva Oral Liquid Expanded Access Program: An Open-Label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP266)
- ClinicalTrials.gov ID
- NCT00162188
- Acronym / sponsor ID
- AI266-914
- Conditions
- HIV Infection
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EfavirenzAlso: Sustiva, BMS-561525Oral Solution, Oral 200 - 600 mg (weight based), once daily. Until further treatment with Sustiva Oral Solution is not warranted. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efavirenz in people with HIV Infection, run by Bristol-Myers Squibb at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.