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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00192608




Registration number
NCT00192608
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
26/06/2009

Titles & IDs
Public title
A 48-Week, Randomised, Study to Describe the Pharmacokinetic Profile and Durability of Atazanavir-Saquinavir-Ritonavir Once Daily and Describe the Pharmacokinetic Profile of Saquinavir-Ritonavir Using Saquinavir 500mg Formulation: the ASK-500 Study
Scientific title
A 48-Week, Randomised, Study to Describe the Pharmacokinetic Profile and Durability of Atazanavir-Saquinavir-Ritonavir Once Daily and Describe the Pharmacokinetic Profile of Saquinavir-Ritonavir Using Saquinavir 500mg Formulation.
Secondary ID [1] 0 0
ACTR012605000660684
Secondary ID [2] 0 0
ASK-500 14047
Universal Trial Number (UTN)
Trial acronym
ASK-500
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 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 - saquinavir 500 formulation
Treatment: Drugs - cross-over arm

Experimental: saquinavir at baseline - patients receiving NRTIs + saquinavir + ritonavir 1000/100 mg BID at entry switch from 200 mg SQV capsules to 500 mg SQV tablets following PK at day 0. After PK at day 8 NRTIs ceased and regimen changed to ATV/SQV/RTV 300/1500/100 QD using 500 mg SQV formulation and continued to week 48

Experimental: other boosted PI at baseline - Patients receiving NRTIs + PI/RTV randomised at baseline to receive ATV/SQVRTV 300/1500/100 QD using 500 mg SQV formulation or ATV/SQV/RTV 300/1600/100 QD using 200 mg formulation. Following PK at day 7, SQV formulation switched with second PK assessment at day 15. Patients then receive ATV/SQV/RTV 300/1500/100 QD to week 48.


Treatment: Drugs: saquinavir 500 formulation
NRTIs + SQV/RTV 1000/100 mg BID using 200 mg SQV capsules switched at entry to ATV/SQV/RTV 300/1500/100 mg QD using 500 mg SQV tablet for 48 weeks with PK at days 0 and 8.

Treatment: Drugs: cross-over arm
either ATV/SQV/RTV 300/1500/100 QD (500 mg SQV tabs) for 7 days then after PK SQV changed to 1600 mg QD (200 mg caps) with PK day 15, or ATV/SQV/RTV 300/1600/100 QD for 7 days with switch to SQV 1500 mg QD. After day 15 PK both groups switch to ATV/SQV/RTV 300/1500/100 QD to week 48
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
HIV-1 infected individuals aged 18 years or over On stable antiretroviral therapy for at
least three months consisting of nucleoside reverse transcriptase inhibitors and protease
inhibitors OR 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
No limit
Sex
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
clinician's 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)
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
Not Applicable
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
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincents Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/ct2/show/NCT00192608
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David A Cooper, MD
Address 0 0
Kirby Institute
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/ct2/show/NCT00192608