Atazanavir/Ritonavir (ATV/RTV) Once a Day (QD) + Raltegravir (RAL) Twice a Day (BID) Stable Switch Study (HARNESS)

This study is currently recruiting participants.

Verified June 2013 by Bristol-Myers Squibb

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01332227

First received: April 7, 2011

Last updated: June 11, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 7, 2011

Last Updated Date

June 11, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects with HIV-1 Ribonucleic acid (RNA) < 40 c/mL through week 24 as measured by quantitative HIV RNA Reverse Transcriptase-Polymerase chain reaction (RT-PCR). [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01332227 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects with HIV-1 RNA < 40 c/mL. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Safety as measured by the frequency of Serious Adverse Events (SAEs), the frequency of Adverse Events(AEs), frequency of AEs leading to discontinuation, the frequency of lab abnormalities and by changes from baseline in fasting lipids. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Safety as measured by the frequency of SAEs, the frequency of AEs, frequency of AEs leading to discontinuation, the frequency of lab abnormalities and by changes from baseline in fasting lipids. [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
Incidence of resistance and characterization of this resistance following a virological rebound [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Incidence of resistance and characterization of this resistance following a virological rebound [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Atazanavir/Ritonavir (ATV/RTV) Once a Day (QD) + Raltegravir (RAL) Twice a Day (BID) Stable Switch Study

Official Title ^ICMJE

An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

Brief Summary

The purpose of this study is to evaluate if HIV-1 infected subjects who are virologically suppressed on a regimen which consists of 2 Nucleoside reverse transcriptase inhibitor's (NRTI) plus any 3rd agent but who are experiencing safety and/or tolerability issues to this regimen will continue to maintain virologic suppression following a switch to a regimen consisting of heat-stable Ritonavir boosted Atazanavir (300/100mg) once daily plus Raltegravir (400mg) twice daily.

Detailed Description

Allocation: Randomized Non-Stratified

Intervention Model: Parallel Versus Comparator(s)

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

HIV, Combination Therapy

Intervention ^ICMJE

Drug: Atazanavir
Capsules, Oral, 300mg, Once daily, 48 weeks

Other Name: Reyataz
Drug: Ritonavir (heat-stable)
Tablets, Oral, 100 mg, Once daily, 48 weeks

Other Name: Norvir
Drug: Raltegravir
Tablets, Oral, 400 mg, Twice daily, 48 weeks

Other Name: Isentress
Drug: Tenofovir/Emtricitabine
Tablets, Oral, 300/200 mg, Once daily, 48 weeks

Other Name: Truvada

Study Arm (s)

Experimental: Arm 1
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Interventions:
- Drug: Atazanavir
- Drug: Ritonavir (heat-stable)
- Drug: Raltegravir
Arm 2
Reference

Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
Interventions:
- Drug: Atazanavir
- Drug: Ritonavir (heat-stable)
- Drug: Tenofovir/Emtricitabine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects who are on a treatment regimen consisting of 2 NRTI + any 3rd agent for at least 3 months immediately prior to screening
Subjects who are virologically suppressed (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to screening
Subjects who are virologically suppressed (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® PCR assay) during screening period
Subjects who are experiencing treatment related safety and/or tolerability issues to a regimen consisting of 2 NRTI + any 3rd. agent

Exclusion Criteria:

History of HAART treatment regimen switch due to virological failure
History of genotypic resistance to any component of the study regimen [Atazanavir (ATV), Raltegravir (RAL), Tenofovir/Emtricitabine (TDF/FTC)]
History of previous exposure to Atazanavir/Ritonavir (ATV/RTV) or RAL prior to entering the study
Subjects experiencing safety and/or tolerability issues to TDF/FTC or RTV
Subjects who have switched any component of their Human Immunodeficiency Virus (HIV) Antiretroviral (ARV) medication in the last 3 months immediately prior to screening or during the screening period

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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.

Location Countries ^ICMJE

United States, France, Germany, Italy, Poland, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01332227

Other Study ID Numbers ^ICMJE

AI424-402, 2009-017032-41

Has Data Monitoring Committee

Yes

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Mayers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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