Phase IIB Pilot of Atazanavir + Raltegravir - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Merck
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00768989

Purpose

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 HIV

Condition	Intervention	Phase
HIV	Drug: Atazanavir Drug: Raltegravir Drug: Ritonavir Drug: TDF/FTC	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Raltegravir Atazanavir sulfate BMS 232632 Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Proportion of subjects with HIV RNA <50 c/mL [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportions of subjects with HIV RNA <50 [ Time Frame: at Weeks 48 and 96 ] [ Designated as safety issue: No ]
Antiretroviral activity [ Time Frame: at Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
Safety as measured by adverse events, laboratory abnormalities and ECG findings [ Time Frame: through Weeks 24, 48, and 96 ] [ Designated as safety issue: Yes ]
Assessment of pharmacokinetics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: Atazanavir Capsules, Oral, 300 mg, twice daily, 96 weeks Drug: Raltegravir Tablet, Oral, 400 mg, twice daily, 96 weeks
A2: Active Comparator	Drug: Atazanavir Capsules, Oral, 300 mg, once daily, 96 weeks Drug: Ritonavir Capsules, Oral, 100 mg, once daily, 96 weeks Drug: TDF/FTC Tablet, Oral, 300 mg TDF; 200 mg FTC, once daily, 96 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 Positive
HIV RNA >=5000
Anti-retroviral treatment-naive
CD4 cell count meeting one of the following criteria:
< 350 cells/mm3
Screening CD4 >=350 and <=500 cells/mm3 ONLY if at least 1 of the following conditions apply:
- Screening HIV RNA > 100,000 c/mL, or
- CD4 decline > 50 - 100 cells/mm3/year, or
- age >=55 years
Any CD4 cell count if subject has a history of an AIDS defining illness
Medically stable

Exclusion Criteria:

Screening HIV genotype showing resistance to any component of the study regimen (ATV, RAL, TDF/FTC)
HBV or HCV co-infection
History of or current presence of cardiac disease
ECG findings:
PR Interval > 260 msec (severe 1st degree AV Block)
QRS Interval > 120 msec

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768989

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Arizona
Southwest Center For Hiv/Aids	Recruiting
Phoenix, Arizona, United States, 85006
Contact: Robert A. Myers, Jr, Site 008
United States, Connecticut
Local Institution	Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Site 006
United States, District of Columbia
Dupont Circle Physicians Group	Recruiting
Washington,Dc, District of Columbia, United States, 20009
Contact: Douglas J. Ward, Site 012
Local Institution	Not yet recruiting
Washington, District of Columbia, United States, 20009
Contact: Site 023
United States, Florida
Local Institution	Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Site 004
United States, Massachusetts
Community Research Initiative Of New England	Recruiting
Brookline, Massachusetts, United States, 02215
Contact: Hannah Olivet, Site 005 617-502-1776
United States, New York
Local Institution	Not yet recruiting
New York, New York, United States, 10016
Contact: Site 011
United States, Ohio
Local Institution	Not yet recruiting
Cincinnati, Ohio, United States, 45267
Contact: Site 022
United States, Texas
Tarrant County Infectious Disease Associates	Recruiting
Ft Worth, Texas, United States, 76104
Contact: Cheryl K. Mcdonald, Site 007 817-810-9810
Local Institution	Not yet recruiting
Houston, Texas, United States, 77074
Contact: Site 009
Local Institution	Not yet recruiting
Houston, Texas, United States, 77004
Contact: Site 010
Argentina, Buenos Aires
Local Institution	Not yet recruiting
Buenos Aires, Bs As, Buenos Aires, Argentina, 1141
Contact: Site 013
Local Institution	Not yet recruiting
Capital Federal, Buenos Aires, Argentina, 1264
Contact: Site 014
Local Institution	Not yet recruiting
Mar Del Plata, Buenos Aires, Argentina, B7600CTO
Contact: Site 020
Local Institution	Not yet recruiting
Capital Federal, Buenos Aires, Argentina, C1405BCK
Contact: Site 021
Argentina, Santa Fe
Local Institution	Not yet recruiting
Rosario, Santa Fe, Argentina, 2000
Contact: Site 019
France
Local Institution	Not yet recruiting
Paris Cedex 10, France, 75475
Contact: Site 015
Local Institution	Not yet recruiting
Paris Cedex 10, France, 75475
Contact: Site 016
Local Institution	Not yet recruiting
Paris Cedex 20, France, 75970
Contact: Site 017
Local Institution	Not yet recruiting
Nantes Cedex 01, France, 44035
Contact: Site 018

Sponsors and Collaborators

Bristol-Myers Squibb

Merck

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI424-376
Study First Received:	October 6, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00768989
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Combination Therapy

Study placed in the following topic categories:

Emtricitabine
Ritonavir
HIV Infections
Acquired Immunodeficiency Syndrome

Tenofovir
Atazanavir
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009