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

NCT01296373 | Completed

• 1 other identifier: HIVNAT 136
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV-1; immune; restoration; observational

Outcome Measures

Primary Outcomes (1)

• Longitudnal Changes in CD4+ T-cell with combination antiretoviral therapy

  2-3 years

Secondary Outcomes (2)

• Longitudinal changes in T-cell subsets with combination antiretroviral therapy

  2-3 years

• Longitudinal changes in CD4+ T-cell immune responses to common pathogens during combination antiretroviral therapy

  2-3 years

Study Arms (1)

HIV-1-infected, off ART

HIV-1-infected, antiretroviral naive or off antiretroviral therapy for at least 12 months with CD4+ T-cell counts less than or equal to 350 cells/µL who are about to commence combination antiretroviral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-1-infected adults aged 18 years or older with untreated HIV-1-infection and CD4+ of 350 cells/uL or less who are about to start or recommence combination antiretroviral therapy which is expected to result in a 1 log or greater decline in plasma HIV RNA

You may qualify if:

• Age ≥18 years;
• Provision of written, informed consent;
• Untreated, HIV infected patients with CD4+ T cell counts 350 cells/µL or less;
• Treatment naïve or off ART for ≥12 months;
• Intention to commence cART that would be expected to reduce viral load by one log or greater

You may not qualify if:

• Inability to give written informed consent;
• Any condition which the treating physician feels would compromise the ability of the patient to participate in the study.

Sponsors & Collaborators

• Kirby Institute: lead
• Chulalongkorn University: collaborator
• HIV Netherlands Australia Thailand Research Collaboration: collaborator
• St Vincent's Hospital, Sydney: collaborator

Study Sites (1)

HIV-NAT

Bangkok, Thailand

Location

Related Publications (1)

• Hsu DC, Kerr SJ, Iampornsin T, Pett SL, Avihingsanon A, Thongpaeng P, Zaunders JJ, Ubolyam S, Ananworanich J, Kelleher AD, Cooper DA. Restoration of CMV-specific-CD4 T cells with ART occurs early and is greater in those with more advanced immunodeficiency. PLoS One. 2013 Oct 10;8(10):e77479. doi: 10.1371/journal.pone.0077479. eCollection 2013.

  PMID: 24130889 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, PBMC and DNA will be stored for 10 years total.

Study Officials

• Sarah L Pett, MD

  National Centre in HIV Epidemiology and Clinical Research.

  STUDY DIRECTOR

• David A Cooper, MD

  National Centre in HIV Epidemiology and Clinical Research.

  STUDY CHAIR

• Anthony D Kelleher, MD

  St Vincent's Hospital, Sydney

  STUDY CHAIR

• Denise Hsu, MD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

• Jintanat Ananworanich, MD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2011
• First Posted: February 15, 2011
• Study Start: September 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

TH (1)