HIV InfectionsASK-500NCT00192608
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
A study testing saquinavir 500 formulation and cross-over arm in people with HIV Infections, run by Kirby Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- saquinavir 500 formulation and cross-over arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2004to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
BACKGROUND The development of anti-HIV therapy for the treatment of HIV disease has improved the quality of life and survival of many people with HIV. However the treatments do not always work over long periods, as medications are often difficult to take due to side effects and a large numbers of pills to be taken. This has lead researchers to look for new ways to treat HIV with medications that require fewer numbers of pills and have fewer side effects.
Atazanavir and saquinavir are two drugs used to treat HIV and come from the same class of drugs known as the protease inhibitors. Atazanavir has the advantage of being taken only once a day. Saquinavir is available in a new formulation (type of pill), which will require fewer numbers of pills to be taken daily.
AIM The purpose of this study is to investigate the use of these two drugs used together with ritonavir as a once daily HIV treatment, which will consist of 6 tablets.
Furthermore this study will look at blood drug levels in individuals on atazanavir, saquinavir and ritonavir with and without the new saquinavir formulation to ensure blood levels of these drugs are adequate.
For individuals currently on the old saquinavir formulation, this study will also look at blood drug levels before and after changing to the new formulation.
- Conditions
- HIV Infections
- Being tested
- saquinavir 500 formulation, cross-over arm
- Keywords
- Pharmacokinetics, atazanavir, saquinavir, ritonavir, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saquinavir 500 formulationDrug
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.
cross-over armDrug
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
| Study group | Role | What they receive |
|---|---|---|
| saquinavir at baseline | Experimental | 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 Receives: Drug: saquinavir 500 formulation |
| other boosted PI at baseline | Experimental | 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. Receives: Drug: cross-over arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pharmacokinectic profile of ATV-SQV-RTV using SQV 500 and 200 formulations.
Measured: week 48
To compare the pharmacokinetic profile of SQV/r 1000/100mg bid using SQV 500 and 200 formulations.
Measured: week 48
To assess the durability and safety of a once daily double boosted PI regimen comprised of ATV300 - SQV1500 - RTV100
Measured: week 48
To assess the decay pharmacokinetics
Measured: week 48
Secondary outcomes (4)
Assessment of adherence to medications.
Measured: week 48
Assessment of changes to CD4 lymphocyte count
Measured: week 48
Assessment of changes in lipid parameters
Measured: week 48
Assessment of changes in monocyte mRNA
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Hoffmann-La Roche
- Investigators
- David A Cooper, MD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192608
- Sponsor's protocol ID
- ASK-500 14047
- Other IDs
- ACTR012605000660684
- Acronym
- ASK-500
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Winston A, Mallon PW, Satchell C, MacRae K, Williams KM, Schutz M, Law M, Cooper DA, Emery S. The safety, efficacy, and pharmacokinetic profile of a switch in antiretroviral therapy to saquinavir, ritonavir, and atazanavir alone for 48 weeks and a switch in the saquinavir formulation. Clin Infect Dis. 2007 Jun 1;44(11):1475-83. doi: 10.1086/517507. Epub 2007 Apr 18.
PubMed 17479946
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00192608
- Acronym / sponsor ID
- ASK-500 / ASK-500 14047
- Conditions
- HIV Infections
- Keywords
- Pharmacokinetics, atazanavir, saquinavir, ritonavir, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND The development of anti-HIV therapy for the treatment of HIV disease has improved the quality of life and survival of many people with HIV. However the treatments do not always work over long periods, as medications are often difficult to take due to side effects and a large numbers of pills to be taken. This has lead researchers to look for new ways to treat HIV with medications that require fewer numbers of pills and have fewer side effects.
Atazanavir and saquinavir are two drugs used to treat HIV and come from the same class of drugs known as the protease inhibitors. Atazanavir has the advantage of being taken only once a day. Saquinavir is available in a new formulation (type of pill), which will require fewer numbers of pills to be taken daily.
AIM The purpose of this study is to investigate the use of these two drugs used together with ritonavir as a once daily HIV treatment, which will consist of 6 tablets.
Furthermore this study will look at blood drug levels in individuals on atazanavir, saquinavir and ritonavir with and without the new saquinavir formulation to ensure blood levels of these drugs are adequate.
For individuals currently on the old saquinavir formulation, this study will also look at blood drug levels before and after changing to the new formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saquinavir at baseline | Experimental | Drug: saquinavir 500 formulationpatients 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 |
| other boosted PI at baseline | Experimental | Drug: cross-over armPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saquinavir 500 formulationNRTIs + 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. | Drug | saquinavir at baseline |
| cross-over armeither 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 | Drug | other boosted PI at baseline |
Primary outcome
To compare the pharmacokinectic profile of ATV-SQV-RTV using SQV 500 and 200 formulations.
Time frame: week 48
To compare the pharmacokinetic profile of SQV/r 1000/100mg bid using SQV 500 and 200 formulations.
Time frame: week 48
To assess the durability and safety of a once daily double boosted PI regimen comprised of ATV300 - SQV1500 - RTV100
Time frame: week 48
To assess the decay pharmacokinetics
Time frame: week 48
4 secondary outcomes
Assessment of adherence to medications.
Time frame: week 48
Assessment of changes to CD4 lymphocyte count
Time frame: week 48
Assessment of changes in lipid parameters
Time frame: week 48
Assessment of changes in monocyte mRNA
Time frame: week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
- Results publication: PubMed 17479946Winston A, Mallon PW, Satchell C, MacRae K, Williams KM, Schutz M, Law M, Cooper DA, Emery S. The safety, efficacy, and pharmacokinetic profile of a switch in antiretroviral therapy to saquinavir, ritonavir, and atazanavir alone for 48 weeks and a switch in the saquinavir formulation. Clin Infect Dis. 2007 Jun 1;44(11):1475-83. doi: 10.1086/517507. Epub 2007 Apr 18.
- National Centre in HIV Epidemiology and Clinical Research HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Cooper, MD principal investigator
Kirby Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saquinavir 500 formulation and cross-over arm in people with HIV Infections, run by Kirby Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the pharmacokinectic profile of ATV-SQV-RTV using SQV 500 and 200 formulations. (time frame: week 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2009.