Ignite Creation Date:
2024-05-05 @ 10:33 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01138241
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2010-06-04
Brief Title:
Tenofovir Renal Toxicity and Glomerular Filtration Rate GFR Validation
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
Incidence and Predictor of TDF Associated Nephrotoxicity and Pharmacokinetic of TDF in HIV-1 Infected Thai Patients A Sub-study of HIV-NAT 006 Long Term Cohort
Status:
COMPLETED
Status Verified Date:
2019-08
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:
To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients
Detailed Description:
With significant reductions in mortality and risk of progression to AIDS with antiretroviral therapy ART complications of long-standing HIV infection and treatment including renal disease have become increasingly important Aging concomitant metabolic diseases and use of potentially nephrotoxic ART lead to higher risk for renal disease in HIV-infected personsWHO encourage TDF as first line ARV regimen The data on TDF related renal toxicity in Asian population is limited
For this cohort we plan to look at these topics
1 proximal tubular dysfunction between TDF and non-TDF user
2 incidence and predictor of TDF related renal toxicity
3 TDF plasma concentrations
4 Pharmacokinetic of TDF when used with boosted DRV boosted ATV and boosted LPV in Thai population
5 Bone density and vitamin D in patients with and without hypophosphatemia
6 Pharmacogenomic of TDF in Thai population
For this cohort we plan to look at these topics
1 proximal tubular dysfunction between TDF and non-TDF user
2 incidence and predictor of TDF related renal toxicity
3 TDF plasma concentrations
4 Pharmacokinetic of TDF when used with boosted DRV boosted ATV and boosted LPV in Thai population
5 Bone density and vitamin D in patients with and without hypophosphatemia
6 Pharmacogenomic of TDF in Thai population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None