Studies
Strategy Studies

HIV-NAT128.1/PK substudy

Study ID: HIV-NAT128.1/PK substudy
A randomised, double‐blind, placebo‐controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral‐naïve HIV‐infected individuals over 96 weeks Encore1 intensive pharmacokinetics sub-study
Status: Completed 2012
Target/Enrolled: 10/10
Collaborator: Chelsea and Westminster Hospital, London, UK; Hospital J.M. Ramos Mejia, Buenos Aires, Argentina; Desmond Tutu HIV Foundation, Cape Town, South Africa; Thai Red Cross-AIDS Research Centre, HIV-NAT Research Collaboration, Bangkok, Thailand

HIV-NAT128.2/CNS substudy

Study ID: HIV-NAT128.2/CNS substudy
A randomised, double‐blind, placebo‐controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral‐naïve HIV‐infected individuals over 96 weeks.
Status: Completed
Target/Enrolled: 20/20

HIV-NAT128.3/Neurocognitive substudy

Study ID: HIV-NAT128.3/Neurocognitive substudy
The neurocognitive sub-study in Encore1: A randomised, double‐blind, placebo‐controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral‐naïve HIV‐infected individuals over 96 weeks
Status: Completed
Target/Enrolled: 124/51

HIV-NAT110.2/LASA HAIR substudy

Study ID: HIV-NAT110.2/LASA HAIR substudy
This study will evaluate the atazanavir/ritonavir concentration in hair
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 480/392 (HIV-NAT = 76)

A randomized open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2-3N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line NNRTI/2N(t)RTI therapy: the SECOND-LINE study

Study ID: HIV-NAT119/SECONDLINE
This is a Phase IIIb/IV, international, randomized, open label study comparing two regimens of combination antiretroviral therapy in people living with HIV with confirmed virological failure of first-line NNRTI/2N(t)RTI regimens. The study runs for 96 weeks but the primary analysis takes place at the week 48.
Status: Closed Oct 2013
Target/Enrolled: 100/67 Thailand (HIV-NAT = 25)
Collaborator: Ploenchan Chetchotisakd (Srinagarind Hospital, Khon Kaen University), Niramon Leeratanapetch (Khon Kaen Hospital), Khuanchai Supparatpinyo (Research Institute for Health Sciences (RIHES), Chiang Mai University)
Site: Approximately 50 sites from Australia, Africa, Asia, Latin America, and Europe. Four sites in Thailand

Evaluation of Novel Concepts in Optimization of antiRetroviral Efficacy

Study ID: HIV-NAT128/ENCORE1
A randomized, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose (400mg) efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naive HIV-infected individuals over 96 weeks. HIV-NAT is the Thai co-ordinating centre. There are three substudies: 1) CNS, 2) Intensive PK and 3) Neurocognitive substudy. Staff from HIV-NAT have initiated this last substudy and will be responsible for the data collection and sub-study analysis.
Status: at 96 weeks of follow-up
Target/Enrolled: 80/70
Collaborator: Ploenchan Chetchotisakd (Srinagarind Hospital, Khon Kaen University) and Khuanchai Supparatpinyo (Research Institute for Health Sciences (RIHES), Chiang Mai University)
Site: This study will involve 51 sites in 17 countries. Three sites in Thailand.

Low dose Atazanavir/r vs. Standard dose Atazanavir/r

Study ID: HIV-NAT110/LASA
A multicenter randomized study to compare the efficacy and safety of lower dose atazanavir/ritonavir (ATV/r 200/100 mg OD) versus standard dose (ATV/r 300/100 mg OD) in combination with 2NRTIs in well virology suppressed HIV-infected adults
Status: Closed on December 2013.
Target/Enrolled: 560/559 Thailand
Collaborator: Wisit Prasithsirikul, Ploenchan Chetchotisakd, Chureeratana Bowonwattanuwong, Patcharee Kantipong, Sasisopin Kiertiburanakul, Virat Klinbuayaem, Supunnee Jirajariyavej Warangkana Munsakul, Niramon Leerattanapetch, Siritorn Nimitvilai, Sukit Bunjongkit, Malee Techapornroog and Supavadee Tongsakulrungraeng
Site: Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Chonburi Hospital, Chiang Rai Prachanukroh Hospital, Ramathibodi Hospital, Sanpatong Hospital, Taksin Hospital, and Vajira Hospital, University of Bangkok Metropolitan Administration, Khon Kaen Hospital, Nakornpathom Hospital, Rayong Hospital Prapokklao Hospital, Pranangklao Hospital

Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure

Study ID: A5288/MULTI-OCTAVE
This is a randomized, open labelled, multicentered international study that will assess the efficacy, safety and tolerability of the combinations of new anti-HIV drugs with and without anti-TB drug. This study will also assess whether text messages can help improve adherence or not.
Status: Ongoing. Expected to close in year 2018
Target/Enrolled: 30/17
Collaborator: RIHES

MARCH study

Study ID: HIV-NAT169
A randomised, open label study to evaluate the efficacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV 1 infected individuals with stable, well controlled plasma HIV RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART)
Status: Closed Nov 2015.
Target/Enrolled: 15/15

Randomized Trial to Prevent Vascular Events in HIV

Study ID: A5332/REPRIEVE
This is a randomized trial to prevent vascular events in HIV , tests whether a daily dose of a statin will reduce the risk of cardiovascular disease among HIV-infected individuals (for whom statins are not already recommended according to 2013 US Cholesterol Treatment Guidelines).
Status: Opened Jan 2015
Target/Enrolled: 300/26
Collaborator: RIHES

Short-Cycle Therapy (SCT) (5 days on/2 days off) in young people with chronic HIV-infection

Study ID: HIV-NAT140/BREATHER (PENTA16)
This study will evaluate the efficacy and safety of short cycle therapy in HIV-infected children.
Status: Long-term follow-up until July 2016
Target/Enrolled: 25/25

START (Strategic Timing of AntiRetroviral Treatment)

Study ID: HIV-NAT097
A Multicenter Study of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1 infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm3. The study will proceed in two phases: (1) a pilot phase, involving at least 900 participants; and (2) a definitive phase, expanding enrollment to an estimated 4,000 participants. Upon completion of the pilot phase, a recommendation will be made to the sponsor (DAIDS, NIAID, NIH) concerning whether the study should be expanded and prolonged into a definitive study. Successful completion of the pilot phase requires enrollment of at least 900 participants in one year by 70 designated INSIGHT sites. For Thailand, seven additional sites were included: Siriraj Hospital, San Patong Hospital, Chonburi Hospital, Chiangrai Prachanukroh Hospital, RIHES Chiang Mai University, Ramathibodi Hospital and Bamrasnaradura Infectious Disease Institute
Status: Even though the study was prematurely terminated, however treatment and follow-up will continue as per the study protocol. This study will close in Dec 2016
Target/Enrolled: 65/117 HIV-NAT site; 250/246 Thailand
Collaborator: Chulalongkorn University, Ploenchan Chetchotisakd (Srinagarind Hospital, Khon Kaen University), Chonburi Regional Hospital. Siriraj Hospital, Mahidol University, Chiangrai Prachanukroh Hospital, Sanpatong Hospital, Bamrasnaradura Infectious Disease Institute, Ramathibodhi Hospital, Mahidol University, Research Institute for Health Sciences (RIHES), Chiang Mai University
Site Pls: Srinagarind Hospital, Khon Kaen University: Ploenchan Chetchotisakd; Siriraj Hospital: Thanomsak Anekthananon; San Patong Hospital: Virat Klinbuayaem; Chonburi Hospital: Chureeratana Bowonwatanuwong; Chiangrai Prachanukroh Hospital: Pacharee Kantipong; RIHES Chiang Mai University: Khuanchai Supparatpinyo; Ramathibodi Hospital: Sasisopin Kiertiburanakul; Bamrasnaradura Infectious Disease Institute: Wisit Prasithsirikul
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