Phase IIB Pilot of Atazanavir + Raltegravir

Stopped early · Phase 2

Conditions studied: HIV

In brief

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).

Key facts

Study ID

NCT00768989

Run by

Bristol-Myers Squibb

People needed

167

Starts

2008-11-01

Expected to finish

2010-05-01

Last updated by the study team

2012-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southwest Center For HIV/AIDS — Phoenix, Arizona, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• Orlando Immunology Center — Orlando, Florida, United States
• The Aaron Diamond AIDS Research Center — New York, New York, United States
• University Of Cincinnati — Cincinnati, Ohio, United States
• Tarrant County Infectious Disease Associates — Fort Worth, Texas, United States
• Therapeutic Concepts, P.A. — Houston, Texas, United States
• Diversified Medical Practices, P.A. — Houston, Texas, United States
• Local Institution — Buenos Aires, Bs As, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Mar del Plata, Buenos Aires, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Nantes, France
• Local Institution — Paris, France
• Local Institution — Paris, France

Full record on ClinicalTrials.gov

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