None listed
Conditions
Brief summary
An open-label study to compare the effectiveness and safety of two dosing schedules of anti-HIV drug combinations of raltegravir plus atazanavir.
Interventions
This is a randomised, open-label, cross-over 8 week study in virologically controlled HIV-infected adults currently receiving atazanavir–containing combination antiretroviral therapy. Participants will be randomised to receive either raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily for 4 weeks followed by raltegravir 800 mg daily plus atazanavir 300 mg and ritonavir 100 mg daily for 4 weeks or. raltegravir 800 mg daily plus atazanavir 300 mg and ritonavir 100 mg daily for 4 week
This is a randomised, open-label, cross-over 8 week study in virologically controlled HIV-infected adults currently receiving atazanavir–containing combination antiretroviral therapy. Participants will be randomised to receive either raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily for 4 weeks followed by raltegravir 800 mg daily plus atazanavir 300 mg and ritonavir 100 mg daily for 4 weeks or. raltegravir 800 mg daily plus atazanavir 300 mg and ritonavir 100 mg daily for 4 weeks followed by raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily for 4 weeks. The study has efficacy, safety and pharmacokinetic endpoints. All drugs will be administered orally. There will be no washout period between the crossover treatments.
Sponsors
National Centre in HIV Epidemiology/The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed