Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

The HIV Netherlands Australia Thailand Research Collaboration

Status: Completed

Conditions: Renal Function; HIV Infection

Treatments: Other: Tc99mDTPA renal clearance

Study type: Observational

Funder types: Other

Identifiers

NCT01138241

HIV-NAT 114

Details and patient eligibility

About

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

Full 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

Enrollment: 700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

700 participants in 3 patient groups

1

Description:

ARV experience (TDF based HAART)

Treatment:

Other: Tc99mDTPA renal clearance

2

Description:

ARV experience (non TDF based ART)

Treatment:

Other: Tc99mDTPA renal clearance

3

Description:

ARV Naive

Treatment:

Other: Tc99mDTPA renal clearance