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NCT01138241 Clinical Trial

Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01138241
Other study ID # HIV-NAT 114
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2010
Est. completion date June 2017

Study information
Verified date August 2019
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 700
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Tc99mDTPA renal clearance
Tc99mDTPA renal clearance only for 200 patients Plasma and urine 24 hr for creatinin, glucose, Creatinin clearance, Phosphatemia, uric acid, HCO3, protein, Microalbuminuria, ß2- microglobulinuria serum creatinine prior and during TDF TDF plasma levels ( only TDF use) using a validated high-performance liquid chromatography (HPLC)-mass method and stored PBMC for intracellular TDF levels stored samples (PBMC) for pharmacogenomic study of transporter gene ie Organic Acid Transporter (OAT) serum for cystanin C ( stored sample prior taking ARV and present time) intensive 24 hours pharmacokinetic study of TDF in 20 patients

Locations
Country Name City State
Thailand HIV-NAT, Thai Red Cross AIDS Research Centre Bangkok

Sponsors (3)
Lead Sponsor Collaborator
The HIV Netherlands Australia Thailand Research Collaboration Chulalongkorn University, Kirby Institute

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Praditpornsilpa K, Avihingsanon A, Chaiwatanarat T, Chaiyahong P, Wongsabut J, Ubolyam S, Chulakadabba A, Avihingsanon Y, Ruxrungtham K, Tunsanga K, Eiam-Ong S, Phanuphak P. Comparisons between validated estimated glomerular filtration rate equations and — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary to validate eGFR Thai equation in HIV-infected adults Test of diagnostic accuracy Blood specimens were drawn to assess plasma radioactivity at 5, 10, 20, 30, 60, 90, 120, 180, and 240 minutes post 99mTc-DTPA injection
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