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Trial registered on ANZCTR


Registration number
ACTRN12605000660684
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
19/10/2005
Date last updated
19/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
ASK-500
Scientific title
A 48-week, randomised, study to describe the pharmacokinetic profile and durability of the antiviral effect of atazanavir-saquinavir-ritonavir once daily and describe the pharmacokinetic profile of saquinavir-ritonavir using saquinavir 500mg formulation when used in the treatment of HIV-1 infection.
Universal Trial Number (UTN)
Trial acronym
ASK-500
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 795 0
Condition category
Condition code
Infection 869 869 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study compares the pharmacokinetic profile of a new saquinavir 500mg formulation to the standard 200mg formulation currently in use. Patients will be sequentially treated with both formulations and pharmacokinetic properties will be measured and compared. This is a 48 week study.
Intervention code [1] 589 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1116 0
To compare the pharmacokinectic profile of ATV-SQV-RTV using SQV 500 and 200 formulations.
Timepoint [1] 1116 0
Assessed at weeks 4 and 48 as change from baseline.
Primary outcome [2] 1117 0
To compare the pharmacokinetic profile of SQV/r 1000/100mg bid using SQV 500 and 200 formulations.
Timepoint [2] 1117 0
Assessed at weeks 4 and 48 as change from baseline.
Primary outcome [3] 1118 0
To assess the durability and safety of a once daily double boosted PI regimen comprised of ATV300 SQV1500 RTV100.
Timepoint [3] 1118 0
Assessed at weeks 4 and 48 as change from baseline.
Primary outcome [4] 1119 0
To assess the decay pharmacokinetics.
Timepoint [4] 1119 0
Assessed at weeks 4 and 48 as change from baseline.
Secondary outcome [1] 2061 0
Assessment of adherence to medications.
Timepoint [1] 2061 0
Assessed at week 48 as change from baseline.
Secondary outcome [2] 2062 0
Assessment of changes to CD4 lymphocyte count.
Timepoint [2] 2062 0
Assessed at week 48 as change from baseline.
Secondary outcome [3] 2063 0
Assessment of changes in lipid parameters.
Timepoint [3] 2063 0
Assessed at week 48 as change from baseline.
Secondary outcome [4] 2064 0
Assessment of changes in monocyte mRNA.
Timepoint [4] 2064 0
Assessed at week 48 as change from baseline.

Eligibility
Key inclusion criteria
HIV-1 infected individuals. - On stable antiretroviral therapy for at least three months consisting of nucleoside reverse transcriptase inhibitors and protease inhibitorsOR- On stable antiretroviral therapy for at least three months consisting of atazanavir-saquinavir-ritonavir- Undetectable HIV RNA viral load for past three months.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals receiving on non-nucleoside reverse transcriptase inhibitors within the past three months- Individuals currently receiving other enzyme inducing agents (as per - Individuals receiving ritonavir at doses greater than 100 mg bid- Active AIDS defining illnesses- Previously documented intolerance or virological failure to saquinavir- Previously documented intolerance or virological failure to atazanavir- Patients who are co-infected with Hepatitis B and are likely to require, in their clinicians opinion, HBV nucleoside therapy during the study.- Female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study- Any current clinical or laboratory parameter of ACTG Grade 4 (except lipids & CK)- Evidence of ongoing alcohol and/or drug or substance abuse that would result in the patient being unreliable in fulfilling the conditions of this protocol- Prior non-adherence to antiretroviral treatment regimens that would result in the patient being unreliable in fulfilling the conditions of this protocol- Evidence of active opportunistic infection, intercurrent illness, drug toxicity or any other condition that would preclude the patient from taking the prescribed antiretroviral regimen- Conditions that might interfere with evaluation of the disease under study.- Conditions/allergies that may compromise the safety of the patient.

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)
Forty volunteers will be recruited and randomized in a 1:1 ratio to each treatment arm. Randomization is performed by the study statistician with concealment through central randomization by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization sequence is generated centrally by the study statistician using software programs created specifically for the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
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)

Funding & Sponsors
Funding source category [1] 958 0
Commercial sector/Industry
Name [1] 958 0
F. Hoffmann - La Roche Ltd
Address [1] 958 0
Country [1] 958 0
Primary sponsor type
Government body
Name
National Centre in HIV Epidemiology and Clinical Research
Address
Country
Australia
Secondary sponsor category [1] 825 0
University
Name [1] 825 0
University of New South Wales
Address [1] 825 0
Country [1] 825 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2259 0
St Vincent's Hospital, Sydney Limited
Ethics committee address [1] 2259 0
Ethics committee country [1] 2259 0
Australia
Date submitted for ethics approval [1] 2259 0
Approval date [1] 2259 0
Ethics approval number [1] 2259 0

Summary
Brief summary
Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV
disease. Saquinavir is currently available in a 200 milligram capsule. Most individuals
currently on saquinavir require to take 5 tablets twice a day. In an attempt to reduce
this number of pills, a new capsule has been developed containing 500 milligrams of
saquinavir. This study will assess: i) blood drug levels in individuals taking both
saquinavir formulations, ii) blood drug levels in individuals taking both saquinavir
formulations when given with atazanavir, iii) 48 weeks of follow up for individuals
receiving the new saquinavir formulation with atazanavir as HIV therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35783 0
Address 35783 0
Country 35783 0
Phone 35783 0
Fax 35783 0
Email 35783 0
Contact person for public queries
Name 9778 0
Claudette Stachell
Address 9778 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 9778 0
Australia
Phone 9778 0
+61 2 93850900
Fax 9778 0
+61 2 93850910
Email 9778 0
csatchell@nchecr.unsw.edu.au
Contact person for scientific queries
Name 706 0
Associate Professor Sean Emery
Address 706 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 706 0
Australia
Phone 706 0
+61 2 93850900
Fax 706 0
+61 2 93850910
Email 706 0
semery@nchecr.unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary