Overview

This trial is active, not recruiting.

Conditions renal function, hiv infection
Treatment tc99mdtpa renal clearance
Sponsor The HIV Netherlands Australia Thailand Research Collaboration
Collaborator Chulalongkorn University
Start date March 2010
End date June 2030
Trial size 700 participants
Trial identifier NCT01138241, HIV-NAT 114

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
ARV experience (TDF based HAART)
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
ARV experience (non TDF based ART)
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
ARV Naive
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

Primary Outcomes

Measure
to validate eGFR Thai equation in HIV-infected adults
time frame: Blood specimens were drawn to assess plasma radioactivity at 5, 10, 20, 30, 60, 90, 120, 180, and 240 minutes post 99mTc-DTPA injection

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Praphan Phanuphak, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by The HIV Netherlands Australia Thailand Research Collaboration.