NCT00206531

Brief Summary

While HIV mainly infects mature T-cells it can also infect newly produced (or naïve) T-cells. These infected naïve T cells may then act a viral reservoir even in patients with undetectable viral loads. Understanding when and how these cells are infected is important because it could help us to understand why patients fail therapy even if they have a persistently undetectable viral load.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 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

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 4, 2006

Status Verified

June 1, 2005

First QC Date

September 13, 2005

Last Update Submit

October 3, 2006

Conditions

HIV Infections

Keywords

HIV-1Naive T-cellsCD31Treatment Naive

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Part 1:
  • \- HIV positive by ELISA and Western Blot VL \>2,000, CD4 \>350
  • Part 2:
  • HIV positive by ELISA and Western Blot
  • Established Chronic infection (15 individuals)
  • Acute infection (15 individuals).
  • Any viral load or CD4 count.
  • No therapy.
  • Any individual who initiates HAART as determined by the treating physician

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sharon R Lewin

    Director, Infectious Diseases Unit, The Alfred Hospital

    PRINCIPAL INVESTIGATOR

  • Jenny Hoy

    Head Clinical Research Unit, Infectious Diseases Unit, Alfred Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon R Lewin

CONTACT

+61 3 9276 3009S.Lewin@alfred.org.au

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Last Updated

October 4, 2006

Record last verified: 2005-06

Locations

AU(1)