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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01332227
First received: April 7, 2011
Last updated: October 15, 2014
Last verified: September 2014

April 7, 2011
October 15, 2014
October 2011
September 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT01332227 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 [ Time Frame: From Day 1 to Week 48 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Virologic Rebound at Weeks 24 and 48 [ Time Frame: Day 1 to Weeks 28 and 48 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: Yes ]
    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.
  • Mean Changes in Fasting Lipid Levels From Baseline to Week 48 [ Time Frame: From Baseline to Week 48 ] [ Designated as safety issue: Yes ]
    LD=low-density lipoprotein; HDL=high-density lipoprotein.
  • 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 ]
Not Provided
Not Provided
 
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1—Infected Patients
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.

Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV, Combination Therapy
  • 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
  • Drug: Tenofovir/Emtricitabine
    Tablets, Oral, 300/200 mg, Once daily, 48 weeks
    Other Name: Truvada
  • Experimental: Atazanavir/Ritonavir + Raltegravir
    Atazanavir + Ritonavir (heat-stable) + Raltegravir
    Interventions:
    • Drug: Atazanavir
    • Drug: Ritonavir (heat-stable)
    • Drug: Raltegravir
  • Atazanavir/Ritonavir + Tenofovir/Emtricitabine

    Reference

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

    Interventions:
    • Drug: Atazanavir
    • Drug: Ritonavir (heat-stable)
    • Drug: Tenofovir/Emtricitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
February 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Poland,   Spain,   United Kingdom
 
NCT01332227
AI424-402, 2009-017032-41
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Mayers Squibb Bristol-Mayers Squibb
Bristol-Myers Squibb
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP