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Completed

NCT Number: NCT01138241

Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

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

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Key information

Conditions

Renal Function Blood-Borne Infections Chronic Disease Communicable Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Kidney Diseases Lentivirus Infections Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

About this study

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:

  • proximal tubular dysfunction between TDF and non-TDF user
  • incidence and predictor of TDF related renal toxicity
  • TDF plasma concentrations
  • Pharmacokinetic of TDF when used with boosted DRV, boosted ATV, and boosted LPV in Thai population
  • Bone density and vitamin D in patients with and without hypophosphatemia.
  • Pharmacogenomic of TDF in Thai population

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years old.
  • HIV RNA < 50 copies/ml (For ART-experienced group only).

Exclusion criteria

  • a history of Tc-99m DTPA allergy,
  • malnutrition (BMI <18m2),
  • amputation,
  • bed-ridden,
  • currently taking cotrimoxazole or cimetidine,
  • acute deterioration of renal function within the last 3 months,
  • serum creatinine > 1.5 mg/dl, or
  • pregnant/lactating.

Treatment and study plan

Tc99mDTPA renal clearance

Other

Tc99mDTPA renal clearance only for 200 patients

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

Primary outcomes

  1. 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

    Test of diagnostic accuracy

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Chulalongkorn University
  • Kirby Institute

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jun 7, 2010
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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