Pharmacokinetic Studies


Study ID: HIV-NAT114.2
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

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: 20/5
Collaborator: Research Institute for Health Sciences (RIHES), Chiang Mai University

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

Study ID: HIV-NAT176.1
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 switching from EFV to RPV in virologically suppressed adolescents.
Status: Will open in Feb 2016
Target/Enrolled: 100/0
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: Closed 2015
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

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

Study ID: HIV-NAT172/ALTER Study
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)
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