NCT00499434

Brief Summary

This study aims at correlating TNF-α, INF-γ, IL-2, IL-4, IL-10 and TGF-β values as dosed by ELISA and mRNA expression by real-time PCR with histopathological hepatic biopsy findings in individuals with HIV/HCV coinfection. This population will be divided into three groups (G1: with no HAART; G2: with detected HIV viral load (HIV VL); G3: with undetected HIV VL), which will be then compared to two control groups with monoinfection by HIV or by HCV, in addition to a third control group comprising normal blood donors.

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
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

Enrollment Period

1.4 years

First QC Date

July 10, 2007

Last Update Submit

December 3, 2009

Conditions

Acquired Immune Deficiency SyndromeHepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedHIV Infections

Keywords

aids

Outcome Measures

Primary Outcomes (1)

  • This study aims at correlating TNF-α, INF-γ, IL-2, IL-4, IL-10 and TGF-β values as dosed by ELISA and mRNA expression by real-time PCR with histopathological hepatic biopsy findings in individuals with HIV/HCV coinfection

    Two years

Secondary Outcomes (1)

  • This study aims at correlating TNF-α, INF-γ, IL-2, IL-4, IL-10 and TGF-β values as dosed by ELISA and mRNA expression by real-time PCR with CD4 and HIV viremia values in individuals with HIV/HCV coinfection

    Two years

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

SAE e Hospital Dia de Aids patients

You may qualify if:

  • Diagnosis of HIV infection or aids
  • Diagnosis of chronic hepatitis C

You may not qualify if:

  • Other hepatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAE e Hospital Dia de Aids

Botucatu, São Paulo, 18618970, Brazil

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHepatitis CHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Alexandre N Barbosa, MD, MSc

    UPECLIN HC FM Botucatu Unesp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2010

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations

BR(1)