A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection

This study has been completed.
Sponsor:
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476411
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010

May 20, 2007
June 4, 2010
December 2006
June 2008   (final data collection date for primary outcome measure)
HBV DNA in HIV-infected patients presenting with a serological pattern of isolated anti-HBcAg compare to non HIV patients with isolated antiHBc [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HBV DNA in HIV-infected patients presenting with a serological pattern of isolated anti-HBcAg compare to non HIV patients with isolated antiHBc [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00476411 on ClinicalTrials.gov Archive Site
  • antiHBs titer after 2 month of third dose of HBV vaccine in both 2 groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • liver function test after HAART in HIV patients compare between negative and positive HBV DNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 3TC resistant after 3TC containing HAART in HIV patients with detectable HBV DNA prior treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • antiHBs titer after 2 month of third dose of HBV vaccine in both 2 groups [ Time Frame: 1 year ]
  • liver function test after HAART in HIV patients compare between negative and positive HBV DNA [ Time Frame: 1 year ]
  • 3TC resistant after 3TC containing HAART in HIV patients with detectable HBV DNA prior treatment [ Time Frame: 1 year ]
Not Provided
Not Provided
 
A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection
The Efficacy of HBV Vaccine Response and Prevalence of Occult HBV Infection in Isolated Anti HBc Between HIV Infected and HIV Un-infected Thai Patients

The prevalence of Hepatitis B core antigen in the Thai population is about 70 %, no data of isolated Hepatitis B core antigen is reported. Hepatitis B core antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. However, this prevalence of isolated antiHBc would be higher in endemic area of HBV infection. There is conflicting data of occult HBV infection in HIV infected patients. In Thailand, perinatal transmission is the main route of transmission which is different from developed countries. Therefore, isolated antiHBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality might be reduced. The prevalence and clinical importance of isolated antiHBc in Thai have not been investigated yet. There is also limited data of HBV vaccine response in this setting.

The prevalence of the Hepatitis B core antigen (anti-HBc)in the Thai population is about 70 %. No data of isolated anti-HBc is reported. Anti-HBc antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. The prevalence of isolated antiHBc antigen is expected to be higher in endemic areas of HBV infection. There is conflicting data of occult HBV infection in HIV-infected patients. In Thailand, perinatal transmission is the main route of HBV transmission, different from developed countries. Therefore, isolated anti-HBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. HBV genotype C is correlated with more cirrhosis and hepatoma than genotype B. A study from Taiwan demonstrated that HBV DNA > 100,000 copies/ml is correlated with cirrhosis and hepatoma. Sustained reduction of HBV replication lowers the risk of hepatoma in HBV related cirrhosis. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality will be reduced.

The prevalence and its clinical importance of isolated anti-HBc in the Thai population has not been investigated yet. There is also limited data of HBV vaccine response in this setting.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B Virus
Biological: HBV vaccine
HBV vaccine 3 doses at month 0, 1, and 6
Experimental: 1
HBV vaccine
Intervention: Biological: HBV vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2009
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected adults followed at HIV-NAT and HIV-NAT affiliated hospitals and Un-infected HIV adults followed at chulalongkorn hospital and blood bank
  • AntiHBc positive without HBsAg and antiHBs
  • Written inform consent

Exclusion Criteria:

  • Patients receiving, or with an anticipated need to receive, any concomitant medications with the potential to decrease the response to HBV vaccine such as long term steroid user, chemotherapy, cancer
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00476411
HIV-NAT 036
Yes
Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
Not Provided
Principal Investigator: Anchalee Avihingsanon, MD HIV-NAT, Thai Red Cross AIDS Research Center
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP