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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.
Age
60 - No limit years
Sex
ALL
Healthy Volunteers
No
Chelsea & Westminster Hospital NHS Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Start Date
April 1, 2011
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2012
Last Updated
November 20, 2019
19
ACTUAL participants
Raltegravir
DRUG
Tenofovir
DRUG
Emtricitabine
DRUG
Lead Sponsor
Imperial College London
NCT04929028
NCT07071623
Data Source & Attribution
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