Trial record 12 of 32 for:    " May 05, 2010":" June 04, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Chulalongkorn University
Kirby Institute
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01138241
First received: June 4, 2010
Last updated: March 27, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention
Renal Function
HIV Infection
Other: Tc99mDTPA renal clearance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Test of diagnostic accuracy


Biospecimen Retention:   Samples With DNA

PBMC collection


Estimated Enrollment: 700
Study Start Date: March 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
ARV experience (TDF based HAART)
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
2
ARV experience (non TDF based ART)
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
3
ARV Naive
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-NAT 006 participants (TDF +non TDF)and ARV naive population

For TDF group, on TDF > 3 months HIV/HBV co-infected patients from COLD (Liver disease and HIV/HBV coinfection in the era of HAART) and TDF surveillance study

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138241

Locations
Thailand
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University
Kirby Institute
Investigators
Principal Investigator: Praphan Phanuphak, MD, PhD HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand
Principal Investigator: Kearkiat Praditpornsilpa, MD Renal division, Faculty of Medicine, Chulalongkorn University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01138241     History of Changes
Other Study ID Numbers: HIV-NAT 114
Study First Received: June 4, 2010
Last Updated: March 27, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
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

ClinicalTrials.gov processed this record on April 19, 2015