Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

The HIV Netherlands Australia Thailand Research Collaboration700 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

700

Conditions

Renal Function HIV Infection

Interventions

Tc99mDTPA renal clearanceOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. \> 18 years old. 2. HIV RNA \< 50 copies/ml (For ART-experienced group only). Exclusion Criteria: 1. a history of Tc-99m DTPA allergy, 2. malnutrition (BMI \<18m2), 3. amputation, 4. bed-ridden, 5. currently taking cotrimoxazole or cimetidine, 6. acute deterioration of renal function within the last 3 months, 7. serum creatinine \> 1.5 mg/dl, or 8. pregnant/lactating.

Locations (1)

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, Thailand

Outcomes

Primary Outcomes

to validate eGFR Thai equation in HIV-infected adults

Test of diagnostic accuracy

Time frame: Blood specimens were drawn to assess plasma radioactivity at 5, 10, 20, 30, 60, 90, 120, 180, and 240 minutes post 99mTc-DTPA injection

Data from ClinicalTrials.gov

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