Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01335620
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT01335620
Study Brief:
Protocol Section:
NCT01335620