Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients

NCT01332227 | Completed Phase 4 Results DMC

• 2 other identifiers: AI424-4022009-017032-41
• Study Type: interventional
• Target: 132
• Locations: 7 countries
• Sites: 38

Brief Summary

The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

Conditions

HIV, Combination Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24

  HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.

  From Day 1 to Week 24

Secondary Outcomes (6)

• Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48

  From Day 1 to Week 48

• Number of Participants With Virologic Rebound at Weeks 24 and 48

  Day 1 to Weeks 28 and 48

• Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24

  Day 1 to Week 24

• Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48

  Day 1 to Week 48

• Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs

  Day 1 to Week 48

Study Arms (2)

Atazanavir/Ritonavir + Raltegravir

EXPERIMENTAL

Atazanavir + Ritonavir (heat-stable) + Raltegravir

Drug: Atazanavir; Drug: Ritonavir (heat-stable); Drug: Raltegravir

Atazanavir/Ritonavir + Tenofovir/Emtricitabine

OTHER

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

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

Interventions

Atazanavir DRUG

Capsules, Oral, 300mg, Once daily, 48 weeks

Also known as: Reyataz

Atazanavir/Ritonavir + Raltegravir; Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Ritonavir (heat-stable) DRUG

Tablets, Oral, 100 mg, Once daily, 48 weeks

Also known as: Norvir

Atazanavir/Ritonavir + Raltegravir; Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Raltegravir DRUG

Tablets, Oral, 400 mg, Twice daily, 48 weeks

Also known as: Isentress

Atazanavir/Ritonavir + Raltegravir

Tenofovir/Emtricitabine DRUG

Tablets, Oral, 300/200 mg, Once daily, 48 weeks

Also known as: Truvada

Atazanavir/Ritonavir + Tenofovir/Emtricitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening
• Virologic suppression (HIV-1 RNA \<50 c/mL) for at least 3 months immediately prior to screening
• Virologic suppression (HIV-1 RNA \<40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
• Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent

You may not qualify if:

• History of switch in highly active antiretroviral therapy due to virologic failure
• History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
• History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
• Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
• Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (38)

Health For Life Clinic Pllc

Little Rock, Arkansas, 72207, United States

Location

Eisenhower Medical Center

Palm Springs, California, 92264, United States

Location

Metropolis Medical Pc

San Francisco, California, 94109, United States

Location

Consultive Medicine

Daytona Beach, Florida, 32117, United States

Location

Orange County Health Dept.

Orlando, Florida, 32805, United States

Location

Triple O Medical Services, P.A.

West Palm Beach, Florida, 33401, United States

Location

The Research Institute

Springfield, Massachusetts, 01105, United States

Location

Aids Care

Rochester, New York, 14607, United States

Location

Local Institution

Paris, Cedex 12, 75551, France

Location

Local Institution

Lyon, 69317, France

Location

Local Institution

Orléans, 45067, France

Location

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Paris, 75020, France

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Paris, 75679, France

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Strasbourg, 67091, France

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Bochum, 44791, Germany

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Frankfurt, 60590, Germany

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Frankfurt am Main, 60311, Germany

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Hamburg, 20246, Germany

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Munich, 80336, Germany

Location

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Genova, 16128, Italy

Location

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Genova, 16132, Italy

Location

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Milan, 20127, Italy

Location

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Milan, 20142, Italy

Location

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Roma, 00149, Italy

Location

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Warsaw, 01-201, Poland

Location

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Wroclaw, 50-136, Poland

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Alicante, 03010, Spain

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Barcelona, 08036, Spain

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Madrid, 28006, Spain

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Madrid, 28007, Spain

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Madrid, 28046, Spain

Location

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Madrid, 28805, Spain

Location

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London, Greater London, SW10 9EL, United Kingdom

Location

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Manchester, Greater Manchester, M8 5RB, United Kingdom

Location

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Brighton, BN2 1ES, United Kingdom

Location

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London, E9 6SR, United Kingdom

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London, NW3 2QG, United Kingdom

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Sheffield, S10 2RX, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Atazanavir Sulfate; Ritonavir; Raltegravir Potassium; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Pyrrolidinones; Pyrrolidines; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Mayers Squibb

  Bristol-Mayers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 19, 2015
• Results First Posted: October 16, 2014

Record last verified: 2015-02

Locations

GB (6); US (8); ES (6); IT (5); DE (5); FR (6); PL (2)