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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01138241
Enrollment
700
Registered
2010-06-07
Start date
2010-03-31
Completion date
2017-06-30
Last updated
2019-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Renal Function

Keywords

HIV, Chronic kidney disease, Glomerular Filtration Rate (GFR), Tenofovir, Serum creatinine (sCr), 24 hr urine creatinine clearance, Serum Cystatin C[40], Modification of Diet in Renal Disease (MDRD), Cockcroft Gault Equation, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), 99mTc-diethylenetriaminepentaacetic acid (Tc-99m DTPA) scan, Validate which renal function assessments can accurately detect GFR and assess the effect of TDF concentration on renal function

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 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

Interventions

OTHERTc99mDTPA 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

Sponsors

Chulalongkorn University
CollaboratorOTHER
Kirby Institute
CollaboratorOTHER_GOV
The HIV Netherlands Australia Thailand Research Collaboration
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
to validate eGFR Thai equation in HIV-infected adultsBlood specimens were drawn to assess plasma radioactivity at 5, 10, 20, 30, 60, 90, 120, 180, and 240 minutes post 99mTc-DTPA injectionTest of diagnostic accuracy

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026