Status:
COMPLETED
Raltegravir and Atazanavir Dosing Strategy Study
Lead Sponsor:
Kirby Institute
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 atazana...
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 recommendat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00874523
Start Date
July 1 2009
End Date
July 1 2011
Last Update
April 12 2012
Active Locations (2)
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1
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
2
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010