NCT01138241

Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

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
• Phase: —
• Study type: Observational
• Enrollment: 700 (actual)
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Renal Function
• HIV Infection

Interventions

Type	Name	Description
OTHER	Tc99mDTPA renal clearance	Tc99mDTPA renal clearance only for 200 patients 1. Plasma and urine 24 hr for creatinin, glucose, Creatinin clearance, Phosphatemia, uric acid, HCO3, protein, Microalbuminuria, ß2- microglobulinuria 2. serum creatinine prior and during TDF 3. TDF plasma levels ( only TDF use) using a validated high-performance liquid chromatography (HPLC)-mass method and stored PBMC for intracellular TDF levels 4. stored samples (PBMC) for pharmacogenomic study of transporter gene ie Organic Acid Transporter (OAT) 5. serum for cystanin C ( stored sample prior taking ARV and present time) 6. intensive 24 hours pharmacokinetic study of TDF in 20 patients

Timeline

• Start date: 2010-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2010-06-07
• Last updated: 2019-08-09

Locations

1 site across 1 country: Thailand