NCT00831207

Brief Summary

Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 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

August 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

December 26, 2008

Last Update Submit

January 27, 2009

Conditions

HIV Patients

Keywords

B-2 microglobulinSerum cytokinesHIV-1ResistanceHAARTTherapeutic failureGenotyping.

Outcome Measures

Primary Outcomes (1)

  • To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.

    At subject enrollment.

Secondary Outcomes (1)

  • To assess the behavior of serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.

    At subject enrollment.

Study Arms (4)

G1

15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ \< 350 cells/mm3.

G2

31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF).

G3

43 HIV-1+ individuals undergoing HAART with TF.

G4

20 normal individuals who served as controls for serum cytokines.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

89 HIV-1-infected individuals assisted by the Tropical Diseases Sector of the Botucatu School of Medicine - UNESP and 20 normal blood donors at the Botucatu Blood Bank.

You may qualify if:

  • HIV-1-infected individuals
  • Over 18 years old
  • Sign the "written consent form" (WCF)

You may not qualify if:

  • Do not presenting other immunosuppression causes, such as neoplasias, transplantations
  • Do not presenting treatment by immunosuppressive substances
  • Do not presenting auto-immune diseases
  • Not be using any type of immunostimulating substances
  • Not at any time of gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, 18618-970, Brazil

Location

Study Officials

  • Ricardo MB Almeida, MSc

    Departamento de Doencas Tropicais e Diagnostico por Imagem - Faculdade de Medicina de Botucatu - UNESP.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2008

First Posted

January 28, 2009

Study Start

August 1, 2004

Primary Completion

November 1, 2005

Study Completion

December 1, 2008

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations

BR(1)