HIV Clinical Trial
Official title:
An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational
study.
Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy
to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24
hour pharmacokinetic visit.
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational
study.
Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be
receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence
of previous HIV- resistance mutations on genotypic resistance testing.
At baseline, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24
hour pharmacokinetic visit.
Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits
that will include standard safety parameters. Assessment of cardiac biomarkers at baseline
and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and
on day 180 will also be undertaken.
Following completion of this study, subjects will recommence their usual antiretroviral
treatment regimen and attend for a study follow up visit.
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