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Raltegravir and Atazanavir Dosing Strategy Study (SPARTA)

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ClinicalTrials.gov Identifier: NCT00874523
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Tracking Information
First Submitted Date  ICMJE March 31, 2009
First Posted Date  ICMJE April 2, 2009
Last Update Posted Date April 12, 2012
Study Start Date  ICMJE July 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies [ Time Frame: 4 and 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00874523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
  • comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing [ Time Frame: 4 and 8 weeks ]
  • comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir [ Time Frame: 4 and 8 weeks ]
  • comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir [ Time Frame: 4 and 8 weeks ]
  • change from baseline in fasting lipid and glycaemic parameters [ Time Frame: weeks 4 and 8 and overall ]
  • change from baseline in CD4+ T-lymphocyte count [ Time Frame: weeks 4 and 8 and overall ]
  • change from baseline in HIV-RNA [ Time Frame: weeks 4 and 8 and overall ]
  • all adverse events attributable to study treatment [ Time Frame: week 8 ]
  • all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment [ Time Frame: week 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Raltegravir and Atazanavir Dosing Strategy Study
Official Title  ICMJE A Randomised, Open-label, Cross-over Study to Examine the Pharmacokinetics and Short-term Safety and Efficacy of Two Dosing Strategies of Raltegravir Plus Atazanavir in HIV-infected Patients
Brief Summary To compare the steady-state pharmacokinetics and short-term efficacy and safety of two dosing strategies of raltegravir and atazanavir in virologically suppressed HIV-infected adults receiving atazanavir-containing combination antiretroviral therapy.
Detailed Description Current HIV treatment guidelines recommend the construction of combination regimens comprising a minimum of three agents from at least two drug classes. There are problems with the current recommendations for although treatments are effective, their success is often limited by tolerability, adverse effects and the need to take many pills. Antiretroviral adherence remains vital and regimens should be simplified wherever possible to facilitate maximal adherence. The recent availability of the potent HIV integrase inhibitor, raltegravir, provides an opportunity to explore moves away from current regimen components. Evidence to support the use of novel regimens must be generated through adequately powered randomized clinical trials. However, before such trials can be undertaken, preliminary data to define the pharmacokinetics, safety and tolerability of these regimens are needed to minimize unnecessary risk for participants. This eight week study will investigate the steady-state pharmacokinetics, and short-term safety and efficacy of two dosing strategies (once and twice daily) of raltegravir plus atazanavir in treatment experienced HIV-infected adults.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • Drug: atazanavir plus raltegravir
    atazanavir 300 mg + raltegravir 400 mg twice daily for 4 weeks then atazanavir 300 mg + ritonavir 100 mg + raltegravir 800 mg once daily for 4 weeks
    Other Names:
    • Reyataz
    • Isentress
  • Drug: atazanavir plus raltegravir
    atazanavir 300 mg + ritonavir 100 mg + raltegravir 800 mg once daily for 4 weeks then atazanavir 300 mg + raltegravir 400 mg twice daily for 4 weeks
    Other Names:
    • Reyataz
    • Isentress
Study Arms  ICMJE
  • Active Comparator: Arm A
    Intervention: Drug: atazanavir plus raltegravir
  • Active Comparator: Arm B
    Intervention: Drug: atazanavir plus raltegravir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2012)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2009)
24
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged ≥ 18 years with laboratory evidence of HIV-1 infection
  • currently receiving 3 or more unchanged antiretroviral agents including atazanavir (with or without ritonavir boosting) for at least 24 weeks prior to study entry
  • plasma HIV RNA less than 50 copies/mL for at least 24 weeks prior to study entry
  • provide written, informed consent.

Exclusion Criteria :

  • prior clinical/virological failure on a PI-containing regimen
  • no clinical history of primary HIV-1 protease mutations identified in local baseline genotypic analysis of HIV with interpretation using current IAS-USA Drug Resistance Mutations in HIV-1
  • women: pregnant, breastfeeding, or not willing to use adequate contraception (including barrier contraception) if of child-bearing potential
  • laboratory abnormalities at screening:

    • absolute neutrophil count (ANC) < 750 cells/mL
    • haemoglobin less than 8.5 g/dL
    • platelet count less than 50 000 cells/mL
    • AST, ALT > 5 times the upper limit of normal
    • serum bilirubin > 5 times the upper limit of normal
  • chronic active hepatitis B infection defined by presence of serum viral hepatitis B surface antigen (HBsAg) or HBV DNA-positive
  • any malabsorption syndrome likely to affect drug absorption
  • concurrent therapy with human growth hormone or other immunomodulatory agents
  • concomitant medication contraindicated for use with either atazanavir or raltegravir therapy
  • any inter-current illness requiring hospitalisation
  • current excessive alcohol or illicit substance use
  • unlikely to be able to remain in follow-up for the protocol-defined period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874523
Other Study ID Numbers  ICMJE SPARTA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirby Institute
Study Sponsor  ICMJE Kirby Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David A Cooper, MD DSc Kirby Institute/UNSW
PRS Account Kirby Institute
Verification Date April 2010

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