HIV InfectionPhase 3SPARTANCT00874523
Raltegravir and Atazanavir Dosing Strategy Study
A Phase 3 study testing atazanavir plus raltegravir in people with HIV Infection, run by Kirby Institute at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- atazanavir plus raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2009to Jul 2011
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
St Vincent's Hospital
Sydney, New South Wales, 2010
About this study
Official 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
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.
Read the detailed description
Current HIV treatment guidelines recommend the construction of combination regimens comprising a minimum of three agents from at least two drug classes. There are problems with the current recommendations for although treatments are effective, their success is often limited by tolerability, adverse effects and the need to take many pills. Antiretroviral adherence remains vital and regimens should be simplified wherever possible to facilitate maximal adherence. The recent availability of the potent HIV integrase inhibitor, raltegravir, provides an opportunity to explore moves away from current regimen components. Evidence to support the use of novel regimens must be generated through adequately powered randomized clinical trials. However, before such trials can be undertaken, preliminary data to define the pharmacokinetics, safety and tolerability of these regimens are needed to minimize unnecessary risk for participants. This eight week study will investigate the steady-state pharmacokinetics, and short-term safety and efficacy of two dosing strategies (once and twice daily) of raltegravir plus atazanavir in treatment experienced HIV-infected adults.
- Conditions
- HIV Infection
- Being tested
- atazanavir plus raltegravir
- Keywords
- raltegravir, atazanavir, HIV infections, pharmacokinetics, antiretroviral agents, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atazanavir plus raltegravirDrug
Also called Reyataz, Isentress
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
atazanavir plus raltegravirDrug
Also called Reyataz, Isentress
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Not described Receives: Drug: atazanavir plus raltegravir |
| Arm B | Active comparator | Not described Receives: Drug: atazanavir plus raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies
Measured: 4 and 8 weeks
Secondary outcomes (8)
comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing
Measured: 4 and 8 weeks
comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir
Measured: 4 and 8 weeks
comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir
Measured: 4 and 8 weeks
change from baseline in fasting lipid and glycaemic parameters
Measured: weeks 4 and 8 and overall
change from baseline in CD4+ T-lymphocyte count
Measured: weeks 4 and 8 and overall
change from baseline in HIV-RNA
Measured: weeks 4 and 8 and overall
all adverse events attributable to study treatment
Measured: week 8
all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- David A Cooper, MD DSc, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874523
- Sponsor's protocol ID
- SPARTA
- Acronym
- SPARTA
- Status last verified
- Apr 2010
- First submitted
- 31 Mar 2009
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00874523
- Acronym / sponsor ID
- SPARTA / SPARTA
- Conditions
- HIV Infection
- Keywords
- raltegravir, atazanavir, HIV infections, pharmacokinetics, antiretroviral agents, treatment experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Apr 2009 (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.
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.
Detailed description
Current HIV treatment guidelines recommend the construction of combination regimens comprising a minimum of three agents from at least two drug classes. There are problems with the current recommendations for although treatments are effective, their success is often limited by tolerability, adverse effects and the need to take many pills. Antiretroviral adherence remains vital and regimens should be simplified wherever possible to facilitate maximal adherence. The recent availability of the potent HIV integrase inhibitor, raltegravir, provides an opportunity to explore moves away from current regimen components. Evidence to support the use of novel regimens must be generated through adequately powered randomized clinical trials. However, before such trials can be undertaken, preliminary data to define the pharmacokinetics, safety and tolerability of these regimens are needed to minimize unnecessary risk for participants. This eight week study will investigate the steady-state pharmacokinetics, and short-term safety and efficacy of two dosing strategies (once and twice daily) of raltegravir plus atazanavir in treatment experienced HIV-infected adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: atazanavir plus raltegravir |
| Arm B | Active comparator | Drug: atazanavir plus raltegravir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
- chronic active hepatitis B infection defined by presence of serum viral hepatitis B surface antigen (HBsAg) or HBV DNA-positive
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 |
|---|---|---|
| atazanavir plus raltegravirAlso: Reyataz, Isentressatazanavir 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 | Drug | Arm A |
| atazanavir plus raltegravirAlso: Reyataz, Isentressatazanavir 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 | Drug | Arm B |
Primary outcome
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies
Time frame: 4 and 8 weeks
8 secondary outcomes
comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing
Time frame: 4 and 8 weeks
comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir
Time frame: 4 and 8 weeks
comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir
Time frame: 4 and 8 weeks
change from baseline in fasting lipid and glycaemic parameters
Time frame: weeks 4 and 8 and overall
change from baseline in CD4+ T-lymphocyte count
Time frame: weeks 4 and 8 and overall
change from baseline in HIV-RNA
Time frame: weeks 4 and 8 and overall
all adverse events attributable to study treatment
Time frame: week 8
all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment
Time frame: week 8
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 12 Apr 2012.
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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 DSc principal investigator
Kirby Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atazanavir plus raltegravir in people with HIV Infection, run by Kirby Institute at 2 sites 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 4 inclusion and 16 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 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies (time frame: 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2012.