Raltegravir and Atazanavir Dosing Strategy Study (SPARTA)

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.