Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

Completed

• Conditions: HIV Infection; Renal Function
• Interventions: Other: Tc99mDTPA renal clearance

• Registration Number: NCT01138241
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief Summary

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

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3	Tc99mDTPA renal clearance	ARV Naive
2	Tc99mDTPA renal clearance	ARV experience (non TDF based ART)
1	Tc99mDTPA renal clearance	ARV experience (TDF based HAART)

Primary Outcome Measures

Name	Time	Method
to validate eGFR Thai equation in HIV-infected adults	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

Trial Locations

Locations (1)

HIV-NAT, Thai Red Cross AIDS Research Centre; 🇹🇭 Bangkok, Thailand