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Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

NCT01138241 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2019-08-09

No results posted yet for this study

Summary

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

Conditions

  • Renal Function
  • HIV Infection

Interventions

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

Sponsors & Collaborators

  • Chulalongkorn University

    collaborator OTHER

  • Kirby Institute

    collaborator OTHER_GOV

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Praphan Phanuphak, MD, PhD · HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand

  • Kearkiat Praditpornsilpa, MD · Renal division, Faculty of Medicine, Chulalongkorn University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138241 on ClinicalTrials.gov