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 human immunodficiency virus (HIV)-infected patients

Phase 3

Completed

• Conditions: chronic HIV infection; Infection - Acquired immune deficiency syndrome (AIDS / HIV)

• Registration Number: ACTRN12609000179235
• Lead Sponsor: ational Centre in HIV Epidemiology/The University of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

aged 18 years or more 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 protease inhibitor-containing regimen
no clinical history of primary HIV-1 protease mutations identified in local baseline genotypic analysis of HIV with interpretation using current International AIDS Society United States of America (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:
o absolute neutrophil count (ANC) less than 750 x 106/L
o haemoglobin less than 8.5 g/dL
o platelet count less than 50 x 109/L
o asparate aminotransferase (AST), alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN)
o serum bilirubin greater than 5 times ULN;
chronic active hepatitis B virus (HBV) infection defined by presence of serum viral hepatitis B surface antigen (HBsAg) or hepatitis B deoxyribonucelic acid (HBV DNA)-positive;
any malabsorption syndrome likely to affect drug absorption (eg Crohn’s disease, chronic pancreatitis);
concurrent therapy with human growth hormone or other immunomodulatory agents;
concomitant medication contraindicated for use with either atazanavir or raltegravir therapy;
subjects who have discontinued any prohibited concomitant agent/s must have ceased this therapy at least 30 days prior to screening;
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of the mean steady-state atazanavir trough plasma concentrations for once (C24) and twice (C12) daily dosing strategies. Drug concentrations in plasma will be quantitated using a validated high-performance liquid chromatography (HPLC) assay.[week 8]