Status:
COMPLETED
Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Brief Summary
This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with tha...
Eligibility Criteria
Inclusion
- Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound
Exclusion
- Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- Women who are pregnant or breastfeeding.
- A life expectancy of \<12 months.
- Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
- Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
End Date :
September 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00096746
Start Date
November 1 2004
End Date
September 1 2006
Last Update
April 13 2011
Active Locations (37)
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1
Local Institution
Phoenix, Arizona, United States
2
Local Institution
Altamonte Springs, Florida, United States
3
Local Institution
Fort Lauderdale, Florida, United States
4
Local Institution
Vero Beach, Florida, United States