Phase IIB Pilot of Atazanavir + Raltegravir

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Atazanavir Sulfate; Emtricitabine; Raltegravir Potassium; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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