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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00874523
Ethics application status
Date submitted
31/03/2009
Date registered
2/04/2009
Date last updated
12/04/2012

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
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

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
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
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

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
Sex
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
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
26
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
Government body
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00874523