Clinical Research Programs in Co-viral and Viral Infections
There are 13 co-viral and viral studies. There are 4 hepatitis, 4 human papilloma virus (HPV), 4 influenza, and 1 cytomegalovirus (CMV) studies of which 2 has been completed (HPV and CMV studies). From the 4 hepatitis studies, 2 are cohort studies for HBV and 1 is an HCV study. Our hepatitis cohort is one of the largest in the world. Other coinfections studies are currently in the pipeline awaiting for funding and/or IRB approval.
Hepatitis co-infection, both HBV and HCV, continues to be one of the leading causes of death among HIV infected patients worldwide despite having available and adequate treatment for HBV whereas for HCV, treatment continues to remain elusive. Furthermore, hepatitis co-infection with HIV accelerates the disease progression. Because of this, HIV patients are also screened for hepatitis and vice versa. Monitoring disease progression by noninvasive technique such as fibroscan has shown high promise and is currently being used in several of our hepatitis/fibrosis studies and substudies. On the other hand, with an increase in cervical and anal cancer among HIV-infected patients, more attention is now also given to HPV. As a result of this, both HIV-infected men and women are recommended to have anal pap smear and pap smears once per year regardless whether the previous result was normal. In Thailand, the TRC-ARC is the only place that offers this new screening tool anal pap smear.
HIV-NAT 098
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
Long-term HBV cohort
HIV-NAT 105
Long term outcome of HBV in Thai cohort of HIV/HBV co-infected patients (Substudy of HIV-NAT 006)
This is a long term cohort to assess HBV and HIV treatment outcome, liver fibrosis, renal function, metabolic syndrome, including vitamin D and Bone health.
HBsAg
HIV-NAT 105.1
Hepatitis B surface antigen levels in long term therapy of tenofovir in HIV-HBV-coinfected patients
This is a cross section study to evaluate the role of quantitative HBsAg in predicting treatment response to HBV.
FLU002
HIV-NAT 122
An International Observational Study to Characterize Adults with Influenza A –Pandemic H1N1 (H1N1v)
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.
FLU003
HIV-NAT 123
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.
HCV
HIV-NAT 125
Characteristics and clinical significances of hepatitis C genotype in HIV-and hepatitis C co-infected Thai patients.
CMV study
HIV-NAT 130
Mortality and Morbidity Risk Factors of Cytomegalovirus Viremia in AIDS Patients Starting Antiretroviral Therapy in Thailand
HPV study
Prevalence and 6- and 12-month incidence of cervical cytological abnormality and HR-HPV infection in a cohort of HAART naïve and HAART experienced women.
HPV-019 PRI
HIV-NAT 161
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)).”
HIV-NAT 163
HPV genotypes present in cervical dysplasia and cervical cancer in HIV-infected women The aim of this study is to investigate the HPV-genotype distribution in HIV-infected women with cervical cysplasia or cervical cancer compared to HIV-uninfected women. Stored tissue samples from Chulalongkorn Hospital are used for HPV genotyping.
IRC 003
HIV-NAT 164
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
This is a multicentered, randomized double-blind phase 2 study that will assess the efficacy, safety, and tolerability of combination antivirals versus the standard treatment for the treatment of influenza in an at-risk outpatient population.
IRC 004
HIV-NAT 165
A Randomized Double-Blind Study Comparing Standard Treatment Versus Placebo for the Treatment of Influenza in Low Risk Adults
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.
HPV Vaccine
HIV-NAT 177
Evaluation of immunogenicity and safety of the bivalent HPV vaccine in HIV-infected women
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The HIV Netherlands Australia Thailand Research Collaboration