Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

Condition(s) targeted: Renal Function; HIV Infection

Intervention: Tc99mDTPA renal clearance (Other)

Phase: N/A

Status: Recruiting

Sponsored by: The HIV Netherlands Australia Thailand Research Collaboration

Official(s) and/or principal investigator(s):
Praphan Phanuphak, MD, PhD, Principal Investigator, Affiliation: HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand
Kearkiat Praditpornsilpa, MD, Principal Investigator, Affiliation: Renal division, Faculty of Medicine, Chulalongkorn University

Overall contact:
Anchalee Avihingsanon, MD, Phone: 662-652-3040, Ext: 107, Email: anchalee.a@hivnat.org

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

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

Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional

Secondary outcome:

eGFR by C-G formula, MDRD, CKD-EPI

GFR by cystatin C

GFR by urine 24 hours

TDF plasma levels

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Anchalee Avihingsanon, MD, Phone: 662-652-3040, Ext: 107, Email: anchalee.a@hivnat.org

HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok 10330, Thailand; Recruiting
Anchalee Avihingsanon, MD, Phone: 662-652-3040, Ext: 107, Email: anchalee.a@hivnat.org
Supaporn Plengsuma, RN, Phone: 662-652-3040, Ext: 165, Email: supaporn.p@hivnat.org
Tawatchai Chaiwatanarat, MD, Sub-Investigator
Yingyos Avihingsanon, MD, Sub-Investigator
Jintanat Ananworanich, MD, PhD, Sub-Investigator

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Starting date: March 2010
Last updated: February 3, 2011