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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 October 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01332227
First received: April 7, 2011
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV, Combination Therapy
 Drug: Atazanavir
Drug: Ritonavir (heat-stable)
Drug: Raltegravir
Drug: Tenofovir/Emtricitabine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Atazanavir + Ritonavir (heat-stable) + Raltegravir
 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
Arm 2

Reference

Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine

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

Detailed Description:

Allocation: Randomized Non-Stratified

Intervention Model: Parallel Versus Comparator(s)

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332227

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.

  Show 34 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Mayers Squibb Bristol-Mayers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01332227     History of Changes
Other Study ID Numbers: AI424-402, 2009-017032-41
Study First Received: April 7, 2011
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health
Italy: The Italian Medicines Agency
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Tenofovir
Tenofovir disoproxil
Ritonavir
Atazanavir
Emtricitabine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013