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Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

HIV Infection Clinical Trial

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

Clinical Trial Summary

To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients

Clinical Trial 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 persons.WHO 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01138241
Study type Observational
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact
Status Completed
Phase
Start date March 2010
Completion date June 2017
View Details
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