Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01335620
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2011-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Sponsor:
Imperial College London
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-022907-23 | EUDRACT_NUMBER | None | View |