Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation
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ClinicalTrials.gov Identifier: NCT01138241 |
Recruitment Status
:
Completed
First Posted
: June 7, 2010
Last Update Posted
: August 10, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Renal Function HIV Infection | Other: Tc99mDTPA renal clearance |
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:
- proximal tubular dysfunction between TDF and non-TDF user
- incidence and predictor of TDF related renal toxicity
- TDF plasma concentrations
- Pharmacokinetic of TDF when used with boosted DRV, boosted ATV, and boosted LPV in Thai population
- Bone density and vitamin D in patients with and without hypophosphatemia.
- Pharmacogenomic of TDF in Thai population
Study Type : | Observational |
Actual Enrollment : | 700 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |

Group/Cohort | Intervention/treatment |
---|---|
1
ARV experience (TDF based HAART)
|
Other: Tc99mDTPA renal clearance
Tc99mDTPA renal clearance only for 200 patients
|
2
ARV experience (non TDF based ART)
|
Other: Tc99mDTPA renal clearance
Tc99mDTPA renal clearance only for 200 patients
|
3
ARV Naive
|
Other: Tc99mDTPA renal clearance
Tc99mDTPA renal clearance only for 200 patients
|
- 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 ]Test of diagnostic accuracy
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
HIV-NAT 006 participants (TDF +non TDF)and ARV naive population
For TDF group, on TDF > 3 months HIV/HBV co-infected patients from COLD (Liver disease and HIV/HBV coinfection in the era of HAART) and TDF surveillance study
Inclusion Criteria:
- > 18 years old.
- HIV RNA < 50 copies/ml (For ART-experienced group only).
Exclusion Criteria:
- a history of Tc-99m DTPA allergy,
- malnutrition (BMI <18m2),
- amputation,
- bed-ridden,
- currently taking cotrimoxazole or cimetidine,
- acute deterioration of renal function within the last 3 months,
- serum creatinine > 1.5 mg/dl, or
- pregnant/lactating.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138241
Thailand | |
HIV-NAT, Thai Red Cross AIDS Research Centre | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Praphan Phanuphak, MD, PhD | HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand | |
Principal Investigator: | Kearkiat Praditpornsilpa, MD | Renal division, Faculty of Medicine, Chulalongkorn University |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT01138241 History of Changes |
Other Study ID Numbers: |
HIV-NAT 114 |
First Posted: | June 7, 2010 Key Record Dates |
Last Update Posted: | August 10, 2017 |
Last Verified: | August 2017 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
HIV Chronic kidney disease Glomerular Filtration Rate (GFR) Tenofovir Serum creatinine (sCr) 24 hr urine creatinine clearance |
Serum Cystatin C[40] Modification of Diet in Renal Disease (MDRD) Cockcroft Gault Equation Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 99mTc-diethylenetriaminepentaacetic acid (Tc-99m DTPA) scan Validate which renal function assessments can accurately detect GFR and assess the effect of TDF concentration on renal function |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |