Renal FunctionNCT01138241
Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation
An observational study of Renal Function and HIV Infection, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Function, HIV Infection
- What is being tested?
- Tc99mDTPA renal clearance
- How many people
- 700 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- > 18 years old.
- HIV RNA < 50 copies/ml (For ART-experienced group only).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients
Read the detailed 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:
- 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
- Conditions
- Renal Function, HIV Infection
- Being tested
- Tc99mDTPA renal clearance
- Keywords
- 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
- Medical subject headings
- HIV Infections, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc99mDTPA renal clearanceOther
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | ARV experience (TDF based HAART) Receives: Other: Tc99mDTPA renal clearance | |
| 2 | ARV experience (non TDF based ART) Receives: Other: Tc99mDTPA renal clearance | |
| 3 | ARV Naive Receives: Other: Tc99mDTPA renal clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
to validate eGFR Thai equation in HIV-infected adults
Test of diagnostic accuracy
Measured: Blood specimens were drawn to assess plasma radioactivity at 5, 10, 20, 30, 60, 90, 120, 180, and 240 minutes post 99mTc-DTPA injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Renal FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Chulalongkorn University, Kirby Institute
- Responsible party
- Sponsor
- Investigators
- Praphan Phanuphak, MD, PhD, Principal investigator, HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, ThailandKearkiat Praditpornsilpa, MD, Principal investigator, Renal division, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138241
- Sponsor's protocol ID
- HIV-NAT 114
- Status last verified
- Aug 2019
- First submitted
- 4 Jun 2010
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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 isotopic glomerular filtration rate in HIV patients. AIDS. 2012 Sep 10;26(14):1781-8. doi: 10.1097/QAD.0b013e328356480d.
PubMed 22713478Avihingsanon A, Kerr SJ, Ramautarsing RA, Praditpornsilpa K, Sophonphan J, Ubolyam S, Avihingsanon Y, Khovidhunkit W, Hiransuthikul N, Ruxrungtham K. The Association of Gender, Age, Efavirenz Use, and Hypovitaminosis D Among HIV-Infected Adults Living in the Tropics. AIDS Res Hum Retroviruses. 2016 Apr;32(4):317-24. doi: 10.1089/AID.2015.0069. Epub 2015 Oct 15.
PubMed 26413903Punyawudho B, Thammajaruk N, Thongpeang P, Matthews G, Lewin SR, Burger D, Ruxrungtham K, Avihingsanon A. Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients. Int J Clin Pharmacol Ther. 2015 Nov;53(11):947-54. doi: 10.5414/CP202386.
PubMed 26308175Rungtivasuwan K, Avihingsanon A, Thammajaruk N, Mitruk S, Burger DM, Ruxrungtham K, Punyawudho B, Pengsuparp T. Influence of ABCC2 and ABCC4 polymorphisms on tenofovir plasma concentrations in Thai HIV-infected patients. Antimicrob Agents Chemother. 2015;59(6):3240-5. doi: 10.1128/AAC.04930-14. Epub 2015 Mar 23.
PubMed 25801567Avihingsanon A, Jitmitraparp S, Tangkijvanich P, Ramautarsing RA, Apornpong T, Jirajariyavej S, Putcharoen O, Treeprasertsuk S, Akkarathamrongsin S, Poovorawan Y, Matthews GV, Lange JM, Ruxrungtham K; HIV-NAT125 study team. Advanced liver fibrosis by transient elastography, fibrosis 4, and alanine aminotransferase/platelet ratio index among Asian hepatitis C with and without human immunodeficiency virus infection: role of vitamin D levels. J Gastroenterol Hepatol. 2014 Sep;29(9):1706-14. doi: 10.1111/jgh.12613.
PubMed 24730732Avihingsanon A, Apornpong T, Ramautarsing RA, Ubolyam S, Tangkijvanich P, Ananworanich J, Lange JM, Matthews G, Lewin SR, Ruxrungtham K; HIV-NAT 105 study team. Decline in serum 25 hydroxyvitamin D levels in HIV-HBV-coinfected patients after long-term antiretroviral therapy. Antivir Ther. 2014;19(1):41-9. doi: 10.3851/IMP2673. Epub 2013 Aug 23.
PubMed 23970149
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01138241
- Acronym / sponsor ID
- HIV-NAT 114
- Conditions
- Renal Function, HIV Infection
- Keywords
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Chulalongkorn University, Kirby Institute
- Study start
- Mar 2010 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients
Detailed 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Tc99mDTPA renal clearanceARV experience (TDF based HAART) |
| 2 | – | Other: Tc99mDTPA renal clearanceARV experience (non TDF based ART) |
| 3 | – | Other: Tc99mDTPA renal clearanceARV Naive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (2 listed)
- > 18 years old.
- HIV RNA < 50 copies/ml (For ART-experienced group only).
Key exclusion criteria (8 listed)
- a history of Tc-99m DTPA allergy,
- malnutrition (BMI <18m2),
- amputation,
- bed-ridden,
- currently taking cotrimoxazole or cimetidine,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc99mDTPA renal clearanceTc99mDTPA 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 | Other | 1, 2, 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Results publication: PubMed 22713478Praditpornsilpa 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 isotopic glomerular filtration rate in HIV patients. AIDS. 2012 Sep 10;26(14):1781-8. doi: 10.1097/QAD.0b013e328356480d.
- Derived from this study: PubMed 26413903Avihingsanon A, Kerr SJ, Ramautarsing RA, Praditpornsilpa K, Sophonphan J, Ubolyam S, Avihingsanon Y, Khovidhunkit W, Hiransuthikul N, Ruxrungtham K. The Association of Gender, Age, Efavirenz Use, and Hypovitaminosis D Among HIV-Infected Adults Living in the Tropics. AIDS Res Hum Retroviruses. 2016 Apr;32(4):317-24. doi: 10.1089/AID.2015.0069. Epub 2015 Oct 15.
- Derived from this study: PubMed 26308175Punyawudho B, Thammajaruk N, Thongpeang P, Matthews G, Lewin SR, Burger D, Ruxrungtham K, Avihingsanon A. Population pharmacokinetics of tenofovir in HIV/HBV co-infected patients. Int J Clin Pharmacol Ther. 2015 Nov;53(11):947-54. doi: 10.5414/CP202386.
- Derived from this study: PubMed 25801567Rungtivasuwan K, Avihingsanon A, Thammajaruk N, Mitruk S, Burger DM, Ruxrungtham K, Punyawudho B, Pengsuparp T. Influence of ABCC2 and ABCC4 polymorphisms on tenofovir plasma concentrations in Thai HIV-infected patients. Antimicrob Agents Chemother. 2015;59(6):3240-5. doi: 10.1128/AAC.04930-14. Epub 2015 Mar 23.
- Derived from this study: PubMed 24730732Avihingsanon A, Jitmitraparp S, Tangkijvanich P, Ramautarsing RA, Apornpong T, Jirajariyavej S, Putcharoen O, Treeprasertsuk S, Akkarathamrongsin S, Poovorawan Y, Matthews GV, Lange JM, Ruxrungtham K; HIV-NAT125 study team. Advanced liver fibrosis by transient elastography, fibrosis 4, and alanine aminotransferase/platelet ratio index among Asian hepatitis C with and without human immunodeficiency virus infection: role of vitamin D levels. J Gastroenterol Hepatol. 2014 Sep;29(9):1706-14. doi: 10.1111/jgh.12613.
- Derived from this study: PubMed 23970149Avihingsanon A, Apornpong T, Ramautarsing RA, Ubolyam S, Tangkijvanich P, Ananworanich J, Lange JM, Matthews G, Lewin SR, Ruxrungtham K; HIV-NAT 105 study team. Decline in serum 25 hydroxyvitamin D levels in HIV-HBV-coinfected patients after long-term antiretroviral therapy. Antivir Ther. 2014;19(1):41-9. doi: 10.3851/IMP2673. Epub 2013 Aug 23.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praphan Phanuphak, MD, PhD principal investigator
HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand
Kearkiat Praditpornsilpa, MD principal investigator
Renal division, Faculty of Medicine, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Function and HIV Infection, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138241, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.