Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by The HIV Netherlands Australia Thailand Research Collaboration.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Chulalongkorn University
Kirby Institute
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01138241
First received: June 4, 2010
Last updated: February 3, 2011
Last verified: February 2011

June 4, 2010
February 3, 2011
March 2010
June 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01138241 on ClinicalTrials.gov Archive Site
  • eGFR by C-G formula, MDRD, CKD-EPI [ Time Frame: June 2010 to May 2011 ] [ Designated as safety issue: No ]
    The eGFR values will be calculated by the re-expressed IDMS traceable MDRD, C-G, and CKD-EPI.
  • GFR by cystatin C [ Time Frame: June 2010 to May 2011 ] [ Designated as safety issue: No ]
    Serum for cystatin C levels will be collected at the time of serum creatinine collection. Cystatin C will be measured by quantitative sandwich enzyme immunoassay. GFR will be estimated from the cystatin C measurement using the following equation18: Cystatin C GFR=86.7/cystatin-4.2.
  • GFR by urine 24 hours [ Time Frame: June 2010 to May 2011 ] [ Designated as safety issue: No ]
    Urine will be collected over a 24-hour period. Verbal and written instructions for collecting urine at home will be given to the patients. Containers (5litres) will be provided for all patients. Creatinine clearance (CrCl) will be calculated using the following equation: CrCl= Urine Cr/Serum cr xQu ; where Qu is the urine volume divided by the time of the actual collection. CrCl estimates will be adjusted for BSA.
  • TDF plasma levels [ Time Frame: June 2010 to May 2011 ] [ Designated as safety issue: No ]
    TDF plasma concentrations are assessed by using a validated high-performance liquid chromatography (HPLC)-mass method. Blood will be collected in lithium-heparin or sodium-heparin tube at mid dose (10-12 hr post dose of TDF). The exact times of sampling will be recorded in the case report forms. Plasma will be stored at - 20 C until analysis and will be transferred to - 80 C for long term storage at HIV-NAT laboratory. Blood for pharmacokinetic study will be obtained at HIV-NAT. The TDF drug level will be determined by HPLC method at the HIV-NAT PK laboratory in Bangkok.
Same as current
Not Provided
Not Provided
 
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

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

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
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

PBMC collection

Non-Probability Sample

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

  • Renal Function
  • HIV Infection
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
  • 1
    ARV experience (TDF based HAART)
    Intervention: Other: Tc99mDTPA renal clearance
  • 2
    ARV experience (non TDF based ART)
    Intervention: Other: Tc99mDTPA renal clearance
  • 3
    ARV Naive
    Intervention: Other: Tc99mDTPA renal clearance
Avihingsanon A, Apornpong T, Ramautarsing RA, Ubolyam S, Tangkijvanich P, Ananworanich J, Lange JM, Matthews G, Lewin SR, Ruxrungtham K; HIV-NAT 105 study team. Decline in serum 25 hydroxyvitamin D levels in HIV-HBV-coinfected patients after long-term antiretroviral therapy. Antivir Ther. 2014;19(1):41-9. doi: 10.3851/IMP2673. Epub 2013 Aug 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
December 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Anchalee Avihingsanon, MD 662-652-3040 ext 107 anchalee.a@hivnat.org
Contact: Supaporn Plengsuma, RN 662-652-3040 ext 165 supaporn.p@hivnat.org
Thailand
 
NCT01138241
HIV-NAT 114
No
Praphan Phanuphak, HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand
The HIV Netherlands Australia Thailand Research Collaboration
  • Chulalongkorn University
  • Kirby Institute
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
The HIV Netherlands Australia Thailand Research Collaboration
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP