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Raltegravir and Atazanavir Dosing Strategy Study (SPARTA)

Primary Purpose

HIV Infection

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

atazanavir plus raltegravir

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring raltegravir, atazanavir, HIV infections, pharmacokinetics, antiretroviral agents, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Holdsworth House Medical Practice
St Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Outcomes

Primary Outcome Measures

comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies

Secondary Outcome Measures

comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing

comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir

comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir

change from baseline in fasting lipid and glycaemic parameters

change from baseline in CD4+ T-lymphocyte count

change from baseline in HIV-RNA

all adverse events attributable to study treatment

all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment

Full Information

NCT ID

NCT00874523

First Posted

March 31, 2009

Last Updated

April 10, 2012

Sponsor

Kirby Institute

1. Study Identification

Unique Protocol Identification Number

NCT00874523

Brief Title

Raltegravir and Atazanavir Dosing Strategy Study

Acronym

SPARTA

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kirby Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

raltegravir, atazanavir, HIV infections, pharmacokinetics, antiretroviral agents, treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Title

Arm B

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

atazanavir plus raltegravir

Other Intervention Name(s)

Reyataz, Isentress

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

atazanavir plus raltegravir

Other Intervention Name(s)

Reyataz, Isentress

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

comparison of mean steady-state raltegravir trough plasma concentrations for once (C24) and twice (C12) daily dosing

Time Frame

4 and 8 weeks

Title

comparison of steady-state pharmacokinetic profiles of once and twice-daily atazanavir

Time Frame

4 and 8 weeks

Title

comparison of the steady-state pharmacokinetic profiles of once and twice-daily raltegravir

Time Frame

4 and 8 weeks

Title

change from baseline in fasting lipid and glycaemic parameters

Time Frame

weeks 4 and 8 and overall

Title

change from baseline in CD4+ T-lymphocyte count

Time Frame

weeks 4 and 8 and overall

Title

change from baseline in HIV-RNA

Time Frame

weeks 4 and 8 and overall

Title

all adverse events attributable to study treatment

Time Frame

week 8

Title

all serious, grade 3 or 4 clinical adverse events, and any adverse event leading to premature cessation of study treatment

Time Frame

week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A Cooper, MD DSc

Organizational Affiliation

Kirby Institute, UNSW

Official's Role

Principal Investigator

Facility Information:

Facility Name

Holdsworth House Medical Practice

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

St Vincent's Hospital

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

12. IPD Sharing Statement

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Raltegravir and Atazanavir Dosing Strategy Study

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