HIV, Combination TherapyPhase 4SPARTANNCT01332227
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
A Phase 4 study testing Atazanavir, Ritonavir (heat-stable) and Raltegravir in people with HIV, Combination Therapy, run by Bristol-Myers Squibb at 38 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Combination Therapy
- What is being tested?
- Atazanavir, Ritonavir (heat-stable) and Raltegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 38 sitesin 7 countries
- Study dates
- Oct 2011to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
United States8 sites
Consultive Medicine
Daytona Beach, Florida, 32117
Health For Life Clinic Pllc
Little Rock, Arkansas, 72207
Orange County Health Dept.
Orlando, Florida, 32805
Eisenhower Medical Center
Palm Springs, California, 92264
Aids Care
Rochester, New York, 14607
Metropolis Medical Pc
San Francisco, California, 94109
The Research Institute
Springfield, Massachusetts, 01105
Triple O Medical Services, P.A.
West Palm Beach, Florida, 33401
France6 sites
Local Institution
Lyon, 69317
Local Institution
Orléans, 45067
Local Institution
Paris, Cedex 12, 75551
Local Institution
Paris, 75020
Local Institution
Paris, 75679
Local Institution
Strasbourg, 67091
Spain6 sites
Local Institution
Alicante, 03010
Local Institution
Barcelona, 08036
Local Institution
Madrid, 28006
Local Institution
Madrid, 28007
Local Institution
Madrid, 28046
Local Institution
Madrid, 28805
United Kingdom6 sites
Local Institution
Brighton, BN2 1ES
Local Institution
London, Greater London, SW10 9EL
Local Institution
London, E9 6SR
Local Institution
London, NW3 2QG
Local Institution
Manchester, Greater Manchester, M8 5RB
Local Institution
Sheffield, S10 2RX
Germany5 sites
Local Institution
Bochum, 44791
Local Institution
Frankfurt, 60590
Local Institution
Frankfurt am Main, 60311
Local Institution
Hamburg, 20246
Local Institution
Munich, 80336
Italy5 sites
Local Institution
Genova, 16128
Local Institution
Genova, 16132
Local Institution
Milan, 20127
Local Institution
Milan, 20142
Local Institution
Roma, 00149
Poland2 sites
Local Institution
Warsaw, 01-201
Local Institution
Wroclaw, 50-136
About this study
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.
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.
Read the detailed description
Allocation: Randomized nonstratified
Intervention model: Parallel versus comparator
- Conditions
- HIV, Combination Therapy
- Being tested
- Atazanavir, Ritonavir (heat-stable), Raltegravir, Tenofovir/Emtricitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Also called Reyataz
Capsules, Oral, 300mg, Once daily, 48 weeks
Ritonavir (heat-stable)Drug
Also called Norvir
Tablets, Oral, 100 mg, Once daily, 48 weeks
RaltegravirDrug
Also called Isentress
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Tenofovir/EmtricitabineDrug
Also called Truvada
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Experimental | Atazanavir + Ritonavir (heat-stable) + Raltegravir Receives: Drug: Atazanavir; Drug: Ritonavir (heat-stable); Drug: Raltegravir |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Other | Reference
Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine Receives: Drug: Atazanavir; Drug: Ritonavir (heat-stable); Drug: Tenofovir/Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 to Week 24
Secondary outcomes (6)
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
Measured: From Day 1 to Week 48
Number of Participants With Virologic Rebound at Weeks 24 and 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
Measured: 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
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Measured: 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
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Measured: 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
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Measured: Day 1 to Week 48
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
LD=low-density lipoprotein; HDL=high-density lipoprotein.
Measured: From Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV, Combination TherapyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Mayers Squibb, Study director, Bristol-Mayers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332227
- Sponsor's protocol ID
- AI424-402
- Other IDs
- 2009-017032-41, 2009
- Acronym
- SPARTAN
- Status last verified
- Feb 2015
- First submitted
- 7 Apr 2011
- Last updated
- 19 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01332227
- Acronym / sponsor ID
- SPARTAN / AI424-402
- Conditions
- HIV, Combination Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Posted 16 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Experimental | Drug: Atazanavir, Drug: Ritonavir (heat-stable), Drug: RaltegravirAtazanavir + Ritonavir (heat-stable) + Raltegravir |
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Other | Drug: Atazanavir, Drug: Ritonavir (heat-stable), Drug: Tenofovir/EmtricitabineReference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtazanavirAlso: ReyatazCapsules, Oral, 300mg, Once daily, 48 weeks | Drug | Atazanavir/Ritonavir + Raltegravir, Atazanavir/Ritonavir + Tenofovir/Emtricitabine |
| Ritonavir (heat-stable)Also: NorvirTablets, Oral, 100 mg, Once daily, 48 weeks | Drug | Atazanavir/Ritonavir + Raltegravir, Atazanavir/Ritonavir + Tenofovir/Emtricitabine |
| RaltegravirAlso: IsentressTablets, Oral, 400 mg, Twice daily, 48 weeks | Drug | Atazanavir/Ritonavir + Raltegravir |
| Tenofovir/EmtricitabineAlso: TruvadaTablets, Oral, 300/200 mg, Once daily, 48 weeks | Drug | Atazanavir/Ritonavir + Tenofovir/Emtricitabine |
Primary outcome
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Time frame: From Day 1 to 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.
6 secondary outcomes
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Time frame: From Day 1 to Week 48
Number of Participants With Virologic Rebound at Weeks 24 and 48
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 to Week 48
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Time frame: From Baseline to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Mayers Squibb study director
Bristol-Mayers Squibb
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atazanavir, Ritonavir (heat-stable) and Raltegravir in people with HIV, Combination Therapy, run by Bristol-Myers Squibb at 38 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, France, Spain, United Kingdom, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 (time frame: From Day 1 to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.