NCT01138241

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

7.3 years

First QC Date

June 4, 2010

Last Update Submit

August 8, 2019

Conditions

Renal FunctionHIV Infection

Keywords

HIVChronic kidney diseaseGlomerular Filtration Rate (GFR)TenofovirSerum creatinine (sCr)24 hr urine creatinine clearanceSerum Cystatin C[40]Modification of Diet in Renal Disease (MDRD)Cockcroft Gault EquationChronic Kidney Disease Epidemiology Collaboration (CKD-EPI)99mTc-diethylenetriaminepentaacetic acid (Tc-99m DTPA) scanValidate which renal function assessments can accurately detect GFR and assess the effect of TDF concentration on renal function

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

1

ARV experience (TDF based HAART)

Other: Tc99mDTPA renal clearance

2

ARV experience (non TDF based ART)

Other: Tc99mDTPA renal clearance

3

ARV Naive

Other: Tc99mDTPA renal clearance

Interventions

Tc99mDTPA renal clearanceOTHER

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

123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • \> 18 years old.
  • HIV RNA \< 50 copies/ml (For ART-experienced group only).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Related Publications (6)

  • 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.

    PMID: 22713478RESULT

  • Avihingsanon 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.

    PMID: 26413903DERIVED

  • Punyawudho 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.

    PMID: 26308175DERIVED

  • Rungtivasuwan 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.

    PMID: 25801567DERIVED

  • Avihingsanon 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.

    PMID: 24730732DERIVED

  • Avihingsanon 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.

    PMID: 23970149DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

PBMC collection

MeSH Terms

Conditions

HIV InfectionsRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

TH(1)