HIV InfectionsNCT00135447
A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen
An observational study of HIV Infections, run by Bristol-Myers Squibb at 84 sites in United States.
Trial summary
The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 5,000 participants
- Where
- 84 sitesUnited States
- Study dates
- Sep 2004to Sep 2009
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected patients failing HAART regimen
Who may be able to join
- Atazanavir - containing antiretroviral regimen
- Confirmed virologic failure defined as either:
- HIV RNA by PCR greater than or equal to 1000 copies/mL after achieving a value of <400 copies/mL on at least 2 consecutive measurements or
- HIV RNA greater than or equal to 1000 copies/mL after 24 weeks of continuous therapy
- At least 18 years old
Who cannot join
- Unable to give informed consent
- Prisoners or subjects involuntarily incarcerated for treatment of psychiatric or physical illness
Trial locations and contacts
84 sites in 1 country.
84 sites in 1 country
United States84 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18102
Emory University
Atlanta, Georgia, 30308
Grady Ponce de Leon Infectious Disease Clinic
Atlanta, Georgia, 30308
Atlanta ID Group
Atlanta, Georgia, 30309
Infectious Disease Solutions
Atlanta, Georgia, 30309
Infectious Disease Group of Atlanta
Atlanta, Georgia, 30312
Family Healthcare of Atlanta, PC
Atlanta, Georgia, 30318
South Florida Clinical Research
Atlantis, Florida, 33462
Chase Brexton Health Services
Baltimore, Maryland, 21201
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
St. Agnes Health Care, Inc.
Baltimore, Maryland, 21229
Be Well Medical Center
Berkley, Michigan, 48072
Vista Medical Partners
Beverly Hills, California, 90210
AIDS Healthcare Foundation
Beverly Hills, California, 90211
Tufts New England Medical Center
Boston, Massachusetts, 02111
Fenway Community Health
Boston, Massachusetts, 02115
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Local Institution
Charlotte, North Carolina, 28209
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Metro Heath Medical Center
Cleveland, Ohio, 44109
Univeristy Speciality Clinics
Columbia, South Carolina, 29203
Philip S. Smith, MD
Cornwall-on-Hudson, New York, 12518
Nicholaos C. Bellos, MD
Dallas, Texas, 75204
Amelia Court HIV Research
Dallas, Texas, 75235
Daniel A. Warner, MD, PA
Daytona Beach, Florida, 32117
Atlanta VA Medical Center
Decatur, Georgia, 30033
Denver Public Health
Denver, Colorado, 80204
Local Institution
Denver, Colorado, 80262
Planned Parenthood Center of El Paso
El Paso, Texas, 79903
Elmhurst Hospital Center
Elmhurst, New York, 11373
Gary J. Richmond, MD, PA
Fort Lauderdale, Florida, 33316
Tarrant Country Infectious Disease Associates
Fort Worth, Texas, 76104
Greenville Hospital System
Greenville, South Carolina, 29605
Valley AIDS Council
Harlingen, Texas, 78550
Fairgrove Primary Health
Hickory, North Carolina, 28602
Biogenomx Research Institute, LLC/CHC1-AP
Hollywood, Florida, 33020
Therapeutic Concepts, P.A.
Houston, Texas, 77004
Diversified Medical Pratices, PA
Houston, Texas, 77027
University of Iowa Healthcare
Iowa City, Iowa, 52242
AIDS Healthcare Foundation
Jacksonville, Florida, 32204
Michaigan State Adult Medicine Clinic
Lansing, Michigan, 48910
University of Kentucky Medical Center
Lexington, Kentucky, 40536
AltaMed Health Services Corporation
Los Angeles, California, 90022
Kaiser Permanente
Los Angeles, California, 90027
Synergy Hematology and Oncology Medical Associates
Los Angeles, California, 90036
Medical Associates of Central Virginia
Lynchburg, Virginia, 24501
Steinhart Medical Associates
Miami, Florida, 33133
University of Miami School of Medicine
Miami, Florida, 33136
Care Resource, Inc.
Miami, Florida, 33137
Albert Canas MD, PA
Miami Beach, Florida, 33140
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Beth Israel Medical Center
New York, New York, 10003
Ricky K. Hsu, MD, PC
New York, New York, 10011
Ronald Grossman, MD
New York, New York, 10016
AIDS Community Research Initiative of America
New York, New York, 10018
James Jones, MD
New York, New York, 11019
Orange Coast Medical Group
Newport Beach, California, 92663
Alameda County Medical Center
Oakland, California, 94602
East Bay AIDS Center
Oakland, California, 94609
Desert Medical Group
Palm Springs, California, 92262
Local Institution
Phoenix, Arizona, 85006
Associates in Infectious Diseases
Port Saint Lucie, Florida, 34952
The Research and Education Group
Portland, Oregon, 97209
Kaiser Permanente Northwest Region
Portland, Oregon, 97227
Calvert Internal Medicine Group
Prince Frederick, Maryland, 20678
Richmond AIDS Consortium
Richmond, Virginia, 23219
Investious Diseases Associates
Riverdale, Georgia, 30274
Health Positive
Safety Harbor, Florida, 34695
Martin M. Mass, MD
San Francisco, California, 94114
Wellspring Medical Group
San Francisco, California, 94114
San Mateo Medical Center
San Mateo, California, 94403
Bach & Godofsky, MD, PA
Sarasota, Florida, 34243
Daniel R. Coulston, MD
Spokane, Washington, 99204
Southern Illinois University of Medicine
Springfield, Illinois, 62702
The Research Institute
Springfield, Massachusetts, 01107
Central West Clinical Research, Inc.
St Louis, Missouri, 63108
Stanford University Medical Center
Stanford, California, 94305
Edward W. Braun, MD PA
Tampa, Florida, 33614
The University of Toledo
Toledo, Ohio, 43614
New York Medical College
Valhalla, New York, 10595
Garden State Infectious Disease Associates
Voorhees Township, New Jersey, 08043
Dupont Circle Physicians Group, P.C.
Washington D.C., District of Columbia, 20009
Charles P. Craig, M.D., P.C.
Ypsilanti, Michigan, 48197
About this study
Official title: A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV)
The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen.
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135447
- Sponsor's protocol ID
- AI424-128
- Status last verified
- Apr 2011
- First submitted
- 25 Aug 2005
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV)
- ClinicalTrials.gov ID
- NCT00135447
- Acronym / sponsor ID
- AI424-128
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Aug 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.
The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients failing HAART regimen
Key inclusion criteria (5 listed)
- Atazanavir - containing antiretroviral regimen
- Confirmed virologic failure defined as either:
- At least 18 years old
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Prisoners or subjects involuntarily incarcerated for treatment of psychiatric or physical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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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
84 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Bristol-Myers Squibb at 84 sites in United States.
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 2 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: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 14 Apr 2011.