NCT00440206

Brief Summary

Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2001

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

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

September 1, 2001

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

February 22, 2007

Last Update Submit

February 26, 2007

Conditions

HIV Infections

Keywords

HIVImmune Markers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be HIV infected
  • must be \≥18 years old
  • must have been taking the same combination ARV regimen (\≥3 drugs) for at least 3 months.
  • Must be experiencing virologic failure (viral load \≥50 copies/mL on two occasions at least 2 weeks apart).
  • must be changed to a salvage antiretroviral regimen
  • Patient has to have signed and dated a full infomred consent.

You may not qualify if:

  • Patient with any of the following abnormal laboratory test results in the previous 3 months:
  • Hemaglobin \<100 g/L
  • Platelet count \<20,000 cells/L
  • INR \≥3.5 IU
  • PTT \≥60 IU
  • Patient with other significant underlying disease (non-HIV) that might impact immune markers ( eg. advanced liver disease, malignancy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

McMaster Health Science Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Maple Leaf Clinic

Toronto, Ontario, M5B 1L6, Canada

Location

Unknown Facility

Toronto, Ontario, M5R 2M8, Canada

Location

Windsor Regional Hospital

Windsor, Ontario, N8W 1L9, Canada

Location

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

  • J Angel, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 26, 2007

Study Start

September 1, 2001

Study Completion

December 1, 2001

Last Updated

February 27, 2007

Record last verified: 2007-02

Locations

CA(5)