NCT00476723

Brief Summary

The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 7, 2010

Status Verified

June 1, 2010

Enrollment Period

2.7 years

First QC Date

November 15, 2006

Last Update Submit

June 4, 2010

Conditions

HIVHepatitis-B

Keywords

HIV infectionHepatitis coinfection

Outcome Measures

Primary Outcomes (1)

  • To characterize circulating and intra-hepatic anti-HBV T-cell responses longitudinally in HIV-1/HBV co-infected individuals, following effective anti-HBV therapy

    48 weeks

Secondary Outcomes (3)

  • To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.

    48 weeks

  • To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy

    48 weeks

  • To determine the effect of HIV-1 co-infection and anti-HBV T-cell responses on clearance of free virions and HBV reservoirs using viral dynamic parameters and direct quantification of HBV hepatic reservoirs

    48 weeks

Study Arms (1)

1

HIV/Hepatitis coinfected patients who use at least one hepatitis activity drug or medications

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

HIV/Hepatitis B coinfected patients using at least one hepatitis active medications in HAART regimen

You may qualify if:

  • HIV positive
  • hepatitis-B co-infected
  • HBV/HIV therapy naive
  • \>18 years of age

You may not qualify if:

  • Unable to sign consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV-NAT

Bangkok, Thailand

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

PBMC

MeSH Terms

Conditions

Hepatitis BHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kiat Ruxrungtham, MD, MSc

    HIV-NAT, The Thai Red Cross AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

May 22, 2007

Study Start

April 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 7, 2010

Record last verified: 2010-06

Locations

TH(1)