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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00874523




Registration number
NCT00874523
Ethics application status
Date submitted
31/03/2009
Date registered
1/04/2009
Date last updated
10/04/2012

Titles & IDs
Public title
Raltegravir and Atazanavir Dosing Strategy Study
Scientific title
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
Secondary ID [1] 0 0
SPARTA
Universal Trial Number (UTN)
Trial acronym
SPARTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - atazanavir plus raltegravir
Treatment: Drugs - atazanavir plus raltegravir
Treatment: Drugs - atazanavir plus raltegravir
Treatment: Drugs - atazanavir plus raltegravir

Active Comparator: Arm A -

Active Comparator: Arm B -

Active Comparator: Arm A -

Active Comparator: Arm B -


Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies
Timepoint [1] 0 0
4 and 8 weeks
Primary outcome [2] 0 0
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies
Timepoint [2] 0 0
4 and 8 weeks
Secondary outcome [1] 0 0
comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing
Timepoint [1] 0 0
4 and 8 weeks
Secondary outcome [2] 0 0
comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir
Timepoint [2] 0 0
4 and 8 weeks
Secondary outcome [3] 0 0
comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir
Timepoint [3] 0 0
4 and 8 weeks
Secondary outcome [4] 0 0
change from baseline in fasting lipid and glycaemic parameters
Timepoint [4] 0 0
weeks 4 and 8 and overall
Secondary outcome [5] 0 0
change from baseline in CD4+ T-lymphocyte count
Timepoint [5] 0 0
weeks 4 and 8 and overall
Secondary outcome [6] 0 0
change from baseline in HIV-RNA
Timepoint [6] 0 0
weeks 4 and 8 and overall
Secondary outcome [7] 0 0
all adverse events attributable to study treatment
Timepoint [7] 0 0
week 8
Secondary outcome [8] 0 0
all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment
Timepoint [8] 0 0
week 8
Secondary outcome [9] 0 0
comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing
Timepoint [9] 0 0
4 and 8 weeks
Secondary outcome [10] 0 0
comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir
Timepoint [10] 0 0
4 and 8 weeks
Secondary outcome [11] 0 0
comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir
Timepoint [11] 0 0
4 and 8 weeks
Secondary outcome [12] 0 0
change from baseline in fasting lipid and glycaemic parameters
Timepoint [12] 0 0
weeks 4 and 8 and overall
Secondary outcome [13] 0 0
change from baseline in CD4+ T-lymphocyte count
Timepoint [13] 0 0
weeks 4 and 8 and overall
Secondary outcome [14] 0 0
change from baseline in HIV-RNA
Timepoint [14] 0 0
weeks 4 and 8 and overall
Secondary outcome [15] 0 0
all adverse events attributable to study treatment
Timepoint [15] 0 0
week 8
Secondary outcome [16] 0 0
all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment
Timepoint [16] 0 0
week 8

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00874523
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David A Cooper, MD DSc
Address 0 0
Kirby Institute/UNSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications