NCT00662194

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 10, 2014

Status Verified

March 1, 2014

Enrollment Period

6 years

First QC Date

April 17, 2008

Last Update Submit

March 6, 2014

Conditions

HIV-hepatitis Co-infectionHIV Infections

Keywords

HIVHBVHCVco-infectioninnate immunity

Outcome Measures

Primary Outcomes (1)

  • TLR change with HIV co-infection therapy

    6 months

Secondary Outcomes (1)

  • TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting

    6 months

Study Arms (8)

1

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

2

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

3

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

4

HIV-HBV co-infected and not receiving ART

5

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

6

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

7

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

8

HIV-HCV co-infected and not receiving ART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinics

You may qualify if:

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

You may not qualify if:

  • HIV-HBV-HCV triple infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

HIV InfectionsCoinfection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Joe Sasadeusz, MD, PhD

    The Alfred

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Audsley, PhD

CONTACT

+613 99030184jennifer.audsley@med.monash.edu.au

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

March 10, 2014

Record last verified: 2014-03

Locations

AU(1)