Studies
Clinical Research Programs in Co-viral and Viral Infections

HIV-NAT161/HPV-019 PRI

Study ID: HIV-NAT161/HPV-019 PRI
A phase IV, observer-blind, randomized, controlled, multicentric study to assess the safety and immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix) administered intramuscularly according to a three-dose schedule (Day 0, Week 6, Month 6) in human immunodeficiency virus-infected (HIV+) female subjects aged 15-25 years, as compared to Merck’s HPV-6/11/16/18 vaccine (Gardasil)
Status: Closed May 2014
Target/Enrolled: 32/32

A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals Versus Standard Treatment for the Treatment of Influenza in Adults at Risk for Complications

Study ID: HIV-NAT164/IRC003
This is a multicentered, randomized double-blind phase 2 study that will assess the efficacy, safety, and tolerability of combination antivirals (ribavirin, Tamiflu and amantadine) versus the standard treatment (Tamiflu) for the treatment of influenza in an at-risk outpatient population.
Status: Opened June 26, 2012. Ongoing. Recruiting.
Target/Enrolled: 560/139 globally; Thailand = 139/74
Collaborator: National Institute of Health (NIH), Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Siriraj Hospital, and the Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Site: 4 sites in Thailand; 48 sites worldwide

A Randomized Double-Blind Study Comparing Standard Treatment Versus Placebo for the Treatment of Influenza in Low Risk Adults

Study ID: HIV-NAT165/IRC004
This is a randomized blinded study that will evaluate whether the standard treatment modifies viral shedding in an ambulatory population with uncomplicated influenza and explore the relationship between virologic effects and clinical effects, effects on proinflammatory mediators, and to start understanding if improvements to virologic shedding correlate with improvements in clinical outcomes.
Status: Opened June 26, 2012. Ongoing. Recruiting.
Target/Enrolled: 560/217 globally; Thailand = 212/150
Collaborator: National Institute of Health (NIH), Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Siriraj Hospital and the Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Site: 4 sites in Thailand; 48 sites worldwide

An International Observational Study to Characterize Adults with Influenza A –Pandemic H1N1 (H1N1v) INSIGHT H1N1v Outpatient Study (FLU 002)

Study ID: HIV-NAT122/FLU002
The purpose of this observational study is to describe participants in geographically diverse locations with influenza A-pandemic H1N1 (H1N1v) virus infection and their clinical course over a 14-day period following enrolment.
Status: Opened Jan. 21, 2010. Ongoing. Recruiting.
Target/Enrolled: Unlimited/1789 (HIV-NAT = 321)
Collaborator: Division of Infectious Diseases, Department of Medicine,University: Opass Putcharoen, Sarawoot Marklon, Leilani Paitoonpong, Gompol Suwanpimolkul, Voraphoj Nilaratanakul, Nontalee Thongsong, Pornvimol Leethong, Paisan Techawaleekul, Suwimon Khusuwan; Khon Kaen University: Ploenchan Chetchotsakd; Bamrasnaradura Infectious Disease Institute: Weerawat Manosuthi
Enrollment (projected): 1,500 patients in Asia, Europe, Australia, North and South America
Site: Chulalongkorn Hospital, Srinakarind Hospital, Khon Kaen University and Bamrasnaradura Infectious Disease Institute

An International Observational Study to Characterize Participants with Influenza A-Pandemic H1N1 (H1N1v) Who Are Hospitalized with Complications of Influenza. INSIGHT H1N1v Influenza Hospitalization Study.

Study ID: HIV-NAT123/FLU003
The purpose of this observational study is to describe the characteristics and outcomes over a 60-day follow-up period of participants in geographically diverse locations who develop influenza A -pandemic H1N1 (H1N1v) and who are hospitalized with complications resulting from influenza.
Status: Opened Jan. 21, 2010. Ongoing. Recruiting.
Target/Enrolled: 500/110 (HIV-NAT = 15)
Collaborator: Division of Infectious Diseases, Department of Medicine,University: Opass Putcharoen, Sarawoot Marklon, Leilani Paitoonpong, Gompol Suwanpimolkul, Voraphoj Nilaratanakul, Nontalee Thongsong, Pornvimol Leethong, Paisan Techawaleekul, Suwimon Khusuwan; Khon Kaen University: Ploenchan Chetchotsakd; Bamrasnaradura Infectious Disease Institute: Weerawat Manosuthi
Enrollment (projected): 1,000 patients in Asia, Europe, Australia, North and South America
Site: Chulalongkorn Hospital, Srinakarind Hospital, Khon Kaen University, and Bamrasnaradura Infectious Disease Institute

Characteristics and clinical significances of hepatitis C genotype in HIV- and hepatitis C co-infected Thai patients

Study ID: HIV-NAT125/HCV
This is a cross-sectional study that will assess the HCV genotype and gene interleukin 28 (IL-28) in Thai HIV/HCV co-infected patients.
Status: Closed June 2014
Target/Enrolled: 200/124

Disease Progression in HIV-HBV co-infection: Prospective longitudinal cohort

Study ID: HIV-NAT178.1/SOFIA AIM 1
This is a long-term, international multi-site cohort to investigate the relationship between changes on liver biopsy, microbial translocation and immune activation.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 31/31
Collaborator: Doherty Institute for Infection and Immunity, Melbourne, Australia; The Austin Hospital, Melbourne; St Vincent’s Hospital, Sydney and Faculty of Medicine, Chulalongkorn University

Effectiveness and tolerability of hepatitis C treatment in HIV-coinfected patients in routine care services in Asia: A pilot model of care project

Study ID: HIV-NAT192/HCV
This is an open-label study of standard HCV therapy with Pegylated-interferon and Ribavirin in HCV-HIV co-infected patients in routine care services in Asia to assess the effectiveness and tolerability of the treatment. To develop a pilot model of care for treatment of HCV in RLS that is replicable and amenable to scaled implementation.
Status: Ongoing. Recruiting
Target/Enrolled: 200/150 (4 sites); HIV-NAT = 75
Collaborator: University of Malaya Medical Centre, Malaysia; Cipto Mangunkusumo General Hospital, Indonesia; Faculty of Medicine, Chulalongkorn University, Thailand; and National Hospital for Tropical Diseases, Vietnam.

Evaluation of the immunogenicity and safety of the bivalent HPV vaccine in HIV-1 infected women in Thailand

Study ID: HIV-NAT177
This is a prospective vaccine immunogenicity study that will assess the systemic immunogenicity of the HPV 16/18 L1 VLP Vaccine in HIV-1 infected women after all three doses of the vaccine.
Status: Data analysis will be completed in 2016
Target/Enrolled: 150/117
Collaborator: Thai Red Cross AIDS Research Centre (TRCARC), Vaccine and Cellular Immunology (VCI) Chulalongkorn University, Bangkok; Faculty of Medicine, Chulalongkorn University; University of California, San Francisco (UCSF), USA

Human Papillomavirus Infection in Perinatally HIV-Infected Adolescents in Asia

Study ID: HIV-NAT185/TA008
This is a longitudinal case-control study to monitor a cohort of perinatally HIV-infected and matched HIV–uninfected adolescent females and males between 12-24 years of age, over 156 weeks in three participating clinical sites in Thailand and two in Vietnam.
Status: Ongoing
Target/Enrolled: 300/294; HIV-NAT = 102

INSIGHT protocol 004

Study ID: HIV-NAT211
This nonrandomized multicenter protocol is designed to obtain and store high-quality genomic DNA from persons who are participating in qualifying INSIGHT studies.
Status: HIV-NAT is the site coordinating center for Bamrasnadura Institute and Khon Kaen University. This study collects and stores specimens for future influenza studies (similar to HIV-NAT 123/Flu003 study). Ongoing
Target/Enrolled: None enrolled from HIV-NAT site
Collaborator: INSIGHT and the Kirby Institute

Liver disease progression in HIV/HBV co-infection SOFIA: cross-sectional cohort

Study ID: HIV-NAT178/SOFIA
This is a cross-sectional, international multi-site cohort study to investigate the relationship between changes on liver biopsy, microbial translocation and immune activation.
Status: Recruiting
Target/Enrolled: 40/38
Collaborator: Doherty Institute for Infection and Immunity, Melbourne, Australia; The Austin Hospital, Melbourne; St Vincent’s Hospital, Sydney and Faculty of Medicine, Chulalongkorn University

Long-term outcome of HBV in Thai cohort of HIV/HBV co-infected patients

Study ID: HIV-NAT105
This is a long-term cohort and cross sectional study to assess the outcome of treatment using lamivudine with and without tenofovir in HIV/HBV co-infected patients
Status: Ongoing indefinitely
Target/Enrolled: Unlimited/155
Collaborator: The Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, Australia; and the Doherty Institute for Infection and Immunity, Melbourne, Australia

Natural history of hepatitis C infection, clinical significances, prognostic factors and treatment outcome/toxicity among Thai HIV-infected patients with chronic hepatitis

Study ID: HIV-NAT174/HCV NHSO
This is a cohort study that will use questionnaires and collect specimens/samples to assess the natural history of HCV, clinical significances, prognostic factors and treatment out and toxicity among HIV/HCV co-infected patients.
Status: Recruiting
Target/Enrolled: 400 (10 sites)/400 (HIV-NAT=196)
Collaborator: NHSO

Program to help develop and propel HCV treatment for HIV/HCV co-infected patients using Peg IFN and Ribavirin through Thailand’s National Health Security Office (NHSO)

Study ID: HIV-NAT202/HCV treatment
This study will assess the quality of life and side effects of treatment with Peg IFN and Ribavarin at 24 weeks versus 48 weeks in HIV/HCV co-infected patients.
Status: Ongoing. Recruiting
Target/Enrolled: 100/25

Prospective Study Determining the Impact That HCV Has in Co-Infected and Mono-Infected Populations With Regards to Cognition, Mood, and Health-Related Quality Of Life Before, During, and Post Interferon and Ribavirin Treatment In Thailand

Study ID: HIV-NAT166.1
This is a prospective study that will compare and contrast the impact that HIV/HCV co-infected and HCV mono-infected has on Cognitive Function, Mood, Health-Related Quality of Life (HRQOL), pre, during and post treatment with pegylated interferon/ribavirin success.
Status: Closed 2014
Target/Enrolled: 150/18

Serological diagnosis of syphilis in HIV-infected patients: 10 years observation

Study ID: HIV-NAT157/Syphilis
This is a retrospective, longitudinal study to assess the prevalence of syphilis among HIV-infected patients This is a longitudinal, prospective cohort study to assess the prevalence of latent syphilis among HIV-infected Thai patients and sexual risk behaviors as well as other sexual transmitted infection (STI).
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: Phase 1 = 1500/1500; Phase 2 = 240/154

TDF surveillance

Study ID: HIV-NAT098
This is a prospective, observational study in a multi-centre, international cohort surveillance study for the detection of hepatitis B virus (HBV) resistance to tenofovir (TDF) in HIV-HBV co-infected patients
Status: Opened on Oct 9, 2008. Ongoing but closed to recruitment. Patients are being followed and monitored.
Target/Enrolled: 52/52
Collaborator: Sharon Lewin, Joe Sasadeusz, Jennifer Audsley and Gail Matthews
Site: Australia: Doherty Institute for Infection and Immunity, Melbourne, Australia; Thailand: Thai Red Cross AIDS Research Centre and Department of Medicine, King Chulalongkorn; Memorial Hospital, Bangkok
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