HIV InfectionNCT00162227
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
A study testing Efavirenz in people with HIV Infection, run by Bristol-Myers Squibb at 29 sites in 2 countries.
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 3-16 who are failing or intolerant of current antiretroviral regimen and who are unable to swallow Sustiva capsules. 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
- 29 sitesin 2 countries
- Study dates
- Sep 2000to 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 regimen
- Limited available viable therapeutic options
- Inability to take capsules/tablets
Who cannot join
- 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
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
Children'S Hospital
Boston, Massachusetts, 02115
The Children'S Memorial Hospital
Chicago, Illinois, 60614
University Of Chicago
Chicago, Illinois, 60637
Metro Health Medical Center
Cleveland, Ohio, 44109
Children'S Diagnostic Treatment Center
Fort Lauderdale, Florida, 33301
Local Institution
Houston, Texas, 77030
The Wellness Center
Las Vegas, Nevada, 89102
Lac & Usc Medical Center
Los Angeles, California, 90033
St Jude Children'S Research Hospital
Memphis, Tennessee, 38105
Schneider'S Childrens Hospital
New Hyde Park, New York, 11042
Lsu Health Sciences Center
New Orleans, Louisiana, 70112
Office Of John Montana
New York, New York, 10011
St Luke'S-Roosevelt Hospital Center
New York, New York, 10025
Women And Childrens Care Center
New York, New York, 10032
Harlem Hospital Center
New York, New York, 10037
Umdnj - New Jersey Medical School
Newark, New Jersey, 07103
Arnold Palmer Hospital For Children And Woman
Orlando, Florida, 32806
Local Institution
Phoenix, Arizona, 85016
State University Of New York At Stony Brook
Stony Brook, New York, 11794
Suny Upstate Medical University
Syracuse, New York, 13210
Bronx Municipal Hospital Center
The Bronx, New York, 10461
Montefiore Medical Center/Aecom
The Bronx, New York, 10461
New York Medical College
Valhalla, New York, 10595
Local Institution
Washington D.C., District of Columbia, 20010
Cleveland Clinic Florida
Weston, Florida, 33331
University Of Massachusetts Medical School
Worcester, Massachusetts, 01655
Local Institution
Youngstown, Ohio, 44502
Puerto Rico2 sites
Local Institution
Arecibo, 00612
Local Institution
San Juan, 00936
About this study
Official title: US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)
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.
- 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 startSep 2000
- 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
- NCT00162227
- Sponsor's protocol ID
- AI266-913
- 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
- US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)
- ClinicalTrials.gov ID
- NCT00162227
- Acronym / sponsor ID
- AI266-913
- Conditions
- HIV Infection
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- 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 3-16 who are failing or intolerant of 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 regimen
- Limited available viable therapeutic options
- Inability to take capsules/tablets
Key exclusion criteria (4 listed)
- 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
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
29 sites in 2 countries: 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 29 sites in 2 countries.
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 29 sites in United States, Puerto Rico. 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.