HIV InfectionsNCT00440206
Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes
An observational study of HIV Infections, run by Ottawa Hospital Research Institute at 5 sites in Canada.
Trial summary
Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 50 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2001to Dec 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
McMaster Health Science Center
Hamilton, Ontario, L8N 3Z5
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Maple Leaf Clinic
Toronto, Ontario, M5B 1L6
Study site
Toronto, Ontario, M5R 2M8
Windsor Regional Hospital
Windsor, Ontario, N8W 1L9
About this study
Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.
Read the detailed description
Over the last several years two markers of disease have been utilized to determine if antiretroviral therapy has been successful, one is a CD4 cell count (reflects the immunocompetence of an infected individual) and a HIV viral load (a blood test used to determine the amount of HIV in the infected individual). However in patients who fail their first line of therapythe likelihood of extended resuppressing viral replication with subsequent therapies may be as low as 25-50%. This information may take several months to determine the new therapies possible continuing success. It would be preferable to have additional markers that respond to therapies in the first several weeks to such therapies, therfore possibly offering patients alternate treatment earlier without potentiatinglong term side effects and possible further drug resistance.
- Conditions
- HIV Infections
- Keywords
- HIV, Immune Markers
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startSep 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Investigators
- J Angel, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440206
- Sponsor's protocol ID
- 2002060-01H
- Status last verified
- Feb 2007
- First submitted
- 22 Feb 2007
- Last updated
- 27 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial of Immunologic Markers to Predict Long Term Virologic Outcomes
- ClinicalTrials.gov ID
- NCT00440206
- Acronym / sponsor ID
- 2002060-01H
- Conditions
- HIV Infections
- Keywords
- HIV, Immune Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ontario HIV Treatment Network
- Study start
- Sep 2001
- Study completion
- Dec 2001
- First posted
- 26 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose is to identify whether immune markerscan predict success of salvage anti-retroviral therapy.
Detailed description
Over the last several years two markers of disease have been utilized to determine if antiretroviral therapy has been successful, one is a CD4 cell count (reflects the immunocompetence of an infected individual) and a HIV viral load (a blood test used to determine the amount of HIV in the infected individual). However in patients who fail their first line of therapythe likelihood of extended resuppressing viral replication with subsequent therapies may be as low as 25-50%. This information may take several months to determine the new therapies possible continuing success. It would be preferable to have additional markers that respond to therapies in the first several weeks to such therapies, therfore possibly offering patients alternate treatment earlier without potentiatinglong term side effects and possible further drug resistance.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Angel, MD principal investigator
Ottawa Hospital Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Ottawa Hospital Research Institute at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.