Clinical trial NCT01332227: Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV, Combination Therapy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Eligibility criteria: Key Inclusion Criteria

* 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

Key Exclusion Criteria

* 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

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
timeFrame: From Day 1 to Week 24
Secondary outcomes:
measure: Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
timeFrame: From Day 1 to Week 48
measure: Number of Participants With Virologic Rebound at Weeks 24 and 48
timeFrame: Day 1 to Weeks 28 and 48
measure: 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
timeFrame: Day 1 to Week 24
measure: 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
timeFrame: Day 1 to Week 48
measure: 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
timeFrame: Day 1 to Week 48
measure: Mean Changes in Fasting Lipid Levels From Baseline to Week 48
timeFrame: From Baseline to Week 48
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Health For Life Clinic Pllc
state: Arkansas
city: Palm Springs
country: United States
facility: Eisenhower Medical Center
state: California
city: San Francisco
country: United States
facility: Metropolis Medical Pc
state: California
city: Daytona Beach
country: United States
facility: Consultive Medicine
state: Florida
city: Orlando
country: United States
facility: Orange County Health Dept.
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Medical Services, P.A.
state: Florida
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Rochester
country: United States
facility: Aids Care
state: New York
city: Paris
country: France
facility: Local Institution
state: Cedex 12
city: Lyons Cedex 04
country: France
facility: Local Institution
city: Orleans Cedex 2
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Bochum
country: Germany
facility: Local Institution
city: Frankfurt Am Main
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Munich
country: Germany
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Alicante
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Brighton
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Sheffield
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Mayers Squibb
name: Bristol-Mayers Squibb
role: STUDY_DIRECTOR
References: