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Phase IIB Pilot of Atazanavir + Raltegravir

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: Atazanavir (Drug); Raltegravir (Drug); Atazanavir (Drug); Ritonavir (Drug); Tenofovir/Emtricitabine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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).

Clinical Details

Official title: A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24

Secondary outcome:

Number of Nonresponders at Week 8

Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96

Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24

Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48

Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96

Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation

Baseline and Mean Change From Baseline in Total Cholesterol Levels

Mean Change From Baseline in Total Bilirubin Level

Mean Change From Baseline in Electrocardiogram Findings

Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval

Raltegravir Cmax in 1 Dosing Interval

Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)

Raltegravir Tmax

Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose

Raltegravir Cmin 12 Hours Postdose

Atazanavir Cmin Prior to the Morning Dose

Raltegravir Cmin Prior to the Morning Dose

Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval

Raltegravir AUC (0-12h) in 1 Dosing Interval

Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval

Atazanavir Individual Inhibitory Quotient (IQ)

Atazanavir Terminal Elimination Half Life

Raltegravir Terminal Elimination Half Life

Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants

Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4

Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)

Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Local Institution, Nantes Cedex 01 44035, France

Local Institution, Paris Cedex 10 75475, France

Local Institution, Paris Cedex 20 75970, France

Southwest Center For HIV/AIDS, Phoenix, Arizona 85006, United States

Local Institution, Buenos Aires, Bs As, Buenos Aires 1141, Argentina

Local Institution, Capital Federal, Buenos Aires 1264, Argentina

Local Institution, Mar Del Plata, Buenos Aires B7600CTO, Argentina

Yale University School Of Medicine, New Haven, Connecticut 06510, United States

Dupont Circle Physicians Group, Washington, District of Columbia 20009, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

The Aaron Diamond AIDS Research Center, New York, New York 10016, United States

University Of Cincinnati, Cincinnati, Ohio 45267, United States

Local Institution, Rosario, Santa Fe 2000, Argentina

Tarrant County Infectious Disease Associates, Ft Worth, Texas 76104, United States

Diversified Medical Practices, P.A., Houston, Texas 77057, United States

Therapeutic Concepts, P.A., Houston, Texas 77004, United States

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: November 2008
Last updated: February 22, 2012

Page last updated: August 23, 2015

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