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:
Bristol-Myers Squibb
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
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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
Drug Information available for:
Emtricitabine
Tenofovir
Ritonavir
Atazanavir
Tenofovir Disoproxil Fumarate
Atazanavir sulfate
Raltegravir
Truvada
Raltegravir potassium
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
Hide Study Locations
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. |
Hide Study LocationsLocations
| United States, Arkansas | |
| Health For Life Clinic Pllc | Recruiting |
| Little Rock, Arkansas, United States, 72207 | |
| Contact: Thomas Jefferson, Site 039 | |
| United States, Florida | |
| Local Institution | Not yet recruiting |
| Altamonte Springs, Florida, United States, 32701 | |
| Contact: Site 011 | |
| Consultive Medicine | Recruiting |
| Daytona Beach, Florida, United States, 32117 | |
| Contact: Daniel Warner, Site 041 386-274-7651 | |
| Local Institution | Not yet recruiting |
| Orlando, Florida, United States, 32804 | |
| Contact: Site 012 | |
| Triple O Medical Services, P.A. | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Contact: Olayemi Osiyemi, Site 006 | |
| United States, Massachusetts | |
| The Research Institute | Recruiting |
| Springfield, Massachusetts, United States, 01105 | |
| Contact: Claudia T. Martorell, Site 040 | |
| United States, New York | |
| Local Institution | Not yet recruiting |
| Rochester, New York, United States, 14607 | |
| Contact: Site 010 | |
| France | |
| Local Institution | Recruiting |
| Paris, Cedex 12, France, 75551 | |
| Contact: Site 036 | |
| Local Institution | Recruiting |
| Lyons Cedex 04, France, 69317 | |
| Contact: Site 034 | |
| Local Institution | Recruiting |
| Orleans Cedex 2, France, 45067 | |
| Contact: Site 035 | |
| Local Institution | Recruiting |
| Paris, France, 75020 | |
| Contact: Site 043 | |
| Local Institution | Recruiting |
| Paris Cedex 14, France, 75679 | |
| Contact: Site 042 | |
| Local Institution | Not yet recruiting |
| Strasbourg Cedex, France, 67091 | |
| Contact: Site 032 | |
| Germany | |
| Local Institution | Recruiting |
| Bochum, Germany, 44791 | |
| Contact: Site 038 | |
| Local Institution | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Site 004 | |
| Local Institution | Recruiting |
| Frankfurt Am Main, Germany, 60311 | |
| Contact: Site 002 | |
| Local Institution | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Site 003 | |
| Local Institution | Recruiting |
| Muenchen, Germany, 80336 | |
| Contact: Site 044 | |
| Italy | |
| Local Institution | Recruiting |
| Genova, Italy, 16128 | |
| Contact: Site 014 | |
| Local Institution | Recruiting |
| Genova, Italy, 16132 | |
| Contact: Site 016 | |
| Local Institution | Recruiting |
| Milano, Italy, 20142 | |
| Contact: Site 013 | |
| Local Institution | Recruiting |
| Milano, Italy, 20127 | |
| Contact: Site 017 | |
| Local Institution | Recruiting |
| Roma, Italy, 00149 | |
| Contact: Site 015 | |
| Poland | |
| Local Institution | Recruiting |
| Warszawa, Poland, 01-201 | |
| Contact: Site 029 | |
| Spain | |
| Local Institution | Recruiting |
| Alicante, Spain, 03010 | |
| Contact: Site 020 | |
| Local Institution | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Site 019 | |
| Local Institution | Recruiting |
| Madrid, Spain, 28046 | |
| Contact: Site 037 | |
| Local Institution | Recruiting |
| Madrid, Spain, 28006 | |
| Contact: Site 022 | |
| Local Institution | Not yet recruiting |
| Madrid, Spain, 28007 | |
| Contact: Site 030 | |
| Local Institution | Recruiting |
| Madrid, Spain, 28805 | |
| Contact: Site 021 | |
| United Kingdom | |
| Local Institution | Recruiting |
| London, Greater London, United Kingdom, SW10 9TH | |
| Contact: Site 027 | |
| Local Institution | Recruiting |
| Manchester, Greater Manchester, United Kingdom, M8 5RB | |
| Contact: Site 024 | |
| Local Institution | Recruiting |
| Brighton, United Kingdom, BN2 1ES | |
| Contact: Site 023 | |
| Local Institution | Recruiting |
| London, United Kingdom, NW3 2QG | |
| Contact: Site 025 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Mayers Squibb | Bristol-Mayers Squibb |
More Information
Additional Information:
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 22, 2013