Pharmacokinetic Studies


Study ID: HIV-NAT114.2
Sub-study of: TDF renal toxicity
This is a cross-sectional study that will compare the mechanism and clinical significance of hypophosphatemia in HIV infected patients receiving antiretroviral therapy
Status: Closed 2015
Target/Enrolled: 120/120
Collaborator: Nephrology Unit, Department of Radiology, Department of Endocrine and Metabolic, and Department of Allergy and Immunology, Faculty of Medicine, Chulalongkorn University


Study ID: HIV-NAT172
Tenofovir pharmacokinetics in HIV-infected Thai adults with moderate renal function impairment receiving either a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based or lopinavir/ritonavir-based antiretroviral therapy. The study is a phase I, non-randomized, open-label, pharmacokinetic study to evaluate the pharmacokinetics of tenofovir (TDF) in HIV-infected Thai adults with a creatinine clearance between 30 to <50mL/min when administered at the recommended dose of 300 mg every 48 hours, and at an alternative dose of 150 mg every 24 hours, as part of a NNRTI-based HAART regimen or a lopinavir/ritonavir-based HAART regimen.
Status: Closed 2014
Target/Enrolled: 12/10 (5 sites: HIV-NAT, Chonburi, Sanpatong, Payao and Nakorn Ping)
Collaborator: Program for HIV Prevention and Treatment (PHPT)

Evaluating pharmacokinetics interactions with vaginal ring contraceptive and ART

Study ID: A5316
This study will look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs).
Status: Opened April 2015
Target/Enrolled: 75 globally with 5 from HIV-NAT

Pharmacokinetic interactions between sex steroid hormones and protease inhibitors in HIV-positive Thai female adolescents

Study ID: HIV-NAT176.1
Sub-study of: Reproductive health in HIV-infected adolescents.
This substudy will assess PK interactions between combined oral contraceptives (COC), such as Marvelon containing 0.03mg ethynylestradiol (EE) and 0.15mg desogestrel, and standard dose of lopinavir/ritonavir (LPV/r).
Status: Manuscript was submitted to a journal
Target/Enrolled: 18/18

Pharmacokinetics of Abacavir once daily vs. twice daily in HIV-infected Thai Children

Study ID: HIV-NAT167
This study will evaluate the pharmacokinetics of abacavir in Thai HIV-infected children.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 30/30
Collaborator: Program for HIV Prevention and Treatment (PHPT)

Pharmacokinetics, efficacy, and safety of rilpivirin in virologic suppressed HIV-infected Thai adolescents

Study ID: HIV-NAT220
This is an open-label, single arm study that will describe the immunologic and virologic outcomes (HIV RNA, CD4) following the switching of EFV to RPV in virologically suppressed adolescents.
Status: Opened on Feb 2016. Ongoing
Target/Enrolled: 30/22
Collaborator: Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok; Department of Pediatrics, Faculty of Medicine, Chulalongkorn University; and Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

TDF renal toxicity

Study ID: HIV-NAT114
This study will assess the 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
Status: Ongoing indefinitely
Target/Enrolled: 700/690
Collaborator: Immunology and nephrology units, Faculty of Medicine, Chulalongkorn University; The Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, Australia; and Radboud University Medical Center, Nijmegen, The Netherlands
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