Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ALternative TEnofovir Dosing in Adults With Moderate Renal Function Impairment

NCT01671982

HIV

COMPLETED PHASE1

Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults

NCT02246998

HIV-1 Infection

COMPLETED PHASE4

Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

NCT01363011

Acquired Immunodeficiency Syndrome HIV Infections

COMPLETED PHASE3

PK TDF in Thai HIV-infected Children

NCT02404259

HIV

COMPLETED NA

TDF Dose Adjustment VS. Switching to TAF in TDF-experienced CHB Patients With Renal Impairment

NCT04391608

Renal Insufficiency Tenofovir

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Function HIV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

ARV experience (TDF based HAART)

Tc99mDTPA renal clearance

Intervention Type OTHER

Tc99mDTPA renal clearance only for 200 patients

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

2

ARV experience (non TDF based ART)

Tc99mDTPA renal clearance

Intervention Type OTHER

Tc99mDTPA renal clearance only for 200 patients

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

3

ARV Naive

Tc99mDTPA renal clearance

Intervention Type OTHER

Tc99mDTPA renal clearance only for 200 patients

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tc99mDTPA renal clearance

Tc99mDTPA renal clearance only for 200 patients

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No