Raltegravir and Atazanavir Dosing Strategy Study

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Treatments: Atazanavir Sulfate; Raltegravir Potassium

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.