Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation
This trial is active, not recruiting.
|Conditions||renal function, hiv infection|
|Treatment||tc99mdtpa renal clearance|
|Sponsor||The HIV Netherlands Australia Thailand Research Collaboration|
|Start date||March 2010|
|End date||June 2030|
|Trial size||700 participants|
|Trial identifier||NCT01138241, HIV-NAT 114|
To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients
to validate eGFR Thai equation in HIV-infected adults
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
Male or female participants at least 18 years old.
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.
|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|
|Principal investigator||Praphan Phanuphak, MD, PhD|
|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|
Call for more information