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A Study to Explore Reconstitution of Immunity in Patients With Advanced HIV-1-infection

NCT01296373 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2013-12-18

No results posted yet for this study

Summary

RESTORE study:Thailand is a prospective observational study of HIV-1-infected patients who are either treatment naïve or who have been off anti-retroviral therapy for a ≥12 months, who have a CD4+ T cell count less than or equal to 350 cells/µL and who have been deemed by their treating physician that commencement of combination antiretroviral therapy (cART), which is expected to reduce plasma HIV RNA by ≥1log10 copies/mL, is necessary.

The primary intent of this protocol is to prospectively establish a cohort of patients from whom clinical data and peripheral blood samples (serum, plasma and peripheral blood mononuclear cells) can be stored for substudies examining reconstitution of the immune system and its relationship to disease outcomes.

Conditions

  • HIV Immune Restoration

Sponsors & Collaborators

  • Chulalongkorn University

    collaborator OTHER

  • HIV Netherlands Australia Thailand Research Collaboration

    collaborator NETWORK

  • St Vincent's Hospital, Sydney

    collaborator OTHER

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Sarah L Pett, MD · National Centre in HIV Epidemiology and Clinical Research.

  • David A Cooper, MD · National Centre in HIV Epidemiology and Clinical Research.

  • Anthony D Kelleher, MD · St Vincent's Hospital, Sydney

  • Denise Hsu, MD · The HIV Netherlands Australia Thailand Research Collaboration

  • Jintanat Ananworanich, MD · The HIV Netherlands Australia Thailand Research Collaboration

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-03-31
Completion
2013-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01296373 on ClinicalTrials.gov