Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)

Bayside Health

Status: Unknown

Conditions: HIV-hepatitis Co-infection; HIV Infections

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00662194

ALF-55/08

Details and patient eligibility

About

Data from this study will provide the first information how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy.

Full description

It has been demonstrated that Toll-like receptors (TLR) are involved in viral hepatitis - hepatitis B (HBV), hepatitis C (HCV) - and HIV in the setting of mono-infection. However the role of innate immunity in the pathogenesis of HIV-hepatitis co-infection in both natural and therapy-associated viral clearance remains unclear. The data from this study may reveal patterns which could predict how and when patients spontaneously, and with therapy, resolve HBV or HCV in the setting of co-infection.

The aim of the study is to evaluate the activity of innate immunity in different subsets of HIV-infected populations co-infected with chronic hepatitis B and/or C. Our hypothesis is that innate immunity is altered in HIV and hepatitis co-infection and that this differs from both hepatitis and HIV mono-infection.

The study is a cross-sectional and longitudinal pilot study of individuals infected with HIV and either HBV or HCV.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV and either HBV or HCV co-infection
• 18 years and older
• able to give informed consent

Exclusion criteria

• HIV-HBV-HCV triple infection

Trial design

40 participants in 8 patient groups

1

Description:

HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count \> 500cells/mm3

2

Description:

HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3

3

Description:

HIV-HBV co-infected and receiving ART and CD4 count \<200cells/mm3

4

Description:

HIV-HBV co-infected and not receiving ART

5

Description:

HIV-HCV co-infected \& receiving anti-retroviral therapy (ART) and CD4 count \> 500cells/mm3

6

Description:

HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3

7

Description:

HIV-HCV co-infected and receiving ART and CD4 count \<200cells/mm3

8

Description:

HIV-HCV co-infected and not receiving ART