Status:
TERMINATED
Phase IIB Pilot of Atazanavir + Raltegravir
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).
Eligibility Criteria
Inclusion
- Human Immunodeficiency Virus (HIV)-1 positive status
- HIV ribonucleic acid (RNA) level \>=5000 copies/mL
- Antiretroviral treatment-naive
- Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:
- \<350 cells/mm\^3
- Screening CD4 \>=350 and \<=500 cells/mm\^3 ONLY if at least 1 of the following conditions apply:
- Screening HIV RNA level \>100,000 copies/mL, or
- CD4 decline \>50-100 cells/mm\^3/year, or
- Age \>=55 years
- Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness
- Medically stable
Exclusion
- Screening HIV genotype showing resistance to any component of the study regimen (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)
- Hepatitis B or hepatitis C coinfection
- History of or current cardiac disease
- Electrocardiogram findings:
- PR Interval \>260 msec (severe 1st degree atrioventricular block)
- QRS Interval \>120 msec
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00768989
Start Date
November 1 2008
End Date
May 1 2010
Last Update
February 24 2012
Active Locations (16)
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1
Southwest Center For HIV/AIDS
Phoenix, Arizona, United States, 85006
2
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
3
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States, 20009
4
Orlando Immunology Center
Orlando, Florida, United States, 32803