The Raltegravir 60+ Study
This is a phase I, 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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Pharmacokinetics [ Time Frame: Day 28 ] [ Designated as safety issue: No ]maraviroc, darunavir and ritonavir maximum and minimum plasma concentrations will be measured and the time to reach each level
- Changes in haematology, biochemistry and virology tests [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus
- cardiovascular disease markers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]• To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.
- Cerebral function [ Time Frame: 6 months ] [ Designated as safety issue: No ]To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Truvada plus Raltegravir
Single arm study
400 mg twice daily
Other Name: Isentress
|Contact: Alan Winston, MB BS||+44 (0)20 3312 firstname.lastname@example.org|
|Contact: Ken Legg, BSc||+44 (0)20 3312 email@example.com|
|Imperial College Healthcare NHS Trust||Recruiting|
|London, United Kingdom, W2 1NY|
|Contact: Ken Legg, BSc +44 (0)20 3312 1464 firstname.lastname@example.org|
|Principal Investigator: Alan Winston, MB BS|
|Chelsea & Westminster Hospital NHS Trust||Recruiting|
|London, United Kingdom, SW10 9TH|
|Contact: Carl Fletcher 020 3315 6323|
|Principal Investigator: Marta Boffito|
|Principal Investigator:||Alan Winston, MB BH||Imperial College London|
|Principal Investigator:||Marta Boffito||Chelsea & Westminster Hospital|