HIV PositiveNCT01154556
RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice
An observational study of HIV Positive, run by Holdsworth House Medical Practice at 1 site in Australia.
Trial summary
An observational retrospective study of NNRTI experienced patients who have virologically failed. The study aims to assess resistance profiling and subsequent prescription patterns of patients on NNRTIs Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Positive
- How many people
- 2,044 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2010to Feb 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Demographic information will be collected from patient medical records for all patients that have used previously, or are currently using an NNRTI as part of HIV treatment therapy.
Who may be able to join
- Documented HIV infection
- Attended Holdsworth House Medical Practice 1999-2009.
- Chosen ART regime includes an NNRTI
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010
About this study
Official title: Non-nucleoside Reverse Transcriptase Inhibitor Failure in a High HIV Caseload Australian Primary Care Practice
An observational retrospective study of NNRTI experienced patients who have virologically failed. The study aims to assess resistance profiling and subsequent prescription patterns of patients on NNRTIs
Read the detailed description
This is a cross-sectional study involving retrospective review of HIV-1 positive patient records who began treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and subsequently failed. Patients who have virologically failed previous NNRTI treatment, or have resistance to 1 drug in the NNRTI class are examined further. Such patients will have attended the clinic every 3-6 months for routine medical care. The data source for variables collected is the patient's electronic medical records. This database is located at Holdsworth House Medical Practice (HHMP), Sydney.
- Conditions
- HIV Positive
- Keywords
- Antiretroviral therapy experienced, failed NNRTI regime
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV1 positive, NNRTI exposure and failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
resistance profiling and subsequent prescription patterns of patients on NNRTIs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 2,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mark Bloch, Holdsworth House Medical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154556
- Sponsor's protocol ID
- RETRIeVE
- Status last verified
- Sep 2015
- First submitted
- 30 Jun 2010
- Last updated
- 21 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-nucleoside Reverse Transcriptase Inhibitor Failure in a High HIV Caseload Australian Primary Care Practice
- ClinicalTrials.gov ID
- NCT01154556
- Acronym / sponsor ID
- RETRIeVE
- Conditions
- HIV Positive
- Keywords
- Antiretroviral therapy experienced, failed NNRTI regime
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,044 participants (actual)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Jul 2010 (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.
An observational retrospective study of NNRTI experienced patients who have virologically failed. The study aims to assess resistance profiling and subsequent prescription patterns of patients on NNRTIs
Detailed description
This is a cross-sectional study involving retrospective review of HIV-1 positive patient records who began treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and subsequently failed. Patients who have virologically failed previous NNRTI treatment, or have resistance to 1 drug in the NNRTI class are examined further. Such patients will have attended the clinic every 3-6 months for routine medical care. The data source for variables collected is the patient's electronic medical records. This database is located at Holdsworth House Medical Practice (HHMP), Sydney.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV1 positive, NNRTI exposure and failure | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Demographic information will be collected from patient medical records for all patients that have used previously, or are currently using an NNRTI as part of HIV treatment therapy.
Key inclusion criteria (3 listed)
- Documented HIV infection
- Attended Holdsworth House Medical Practice 1999-2009.
- Chosen ART regime includes an NNRTI
Key exclusion criteria (0 listed)
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
resistance profiling and subsequent prescription patterns of patients on NNRTIs
Time frame: 1 year
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 21 Sep 2015.
Related trials for HIV Positive
Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Drug Resistant Tuberculosis
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
RecruitingPhase 2/3
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Tuberculosis, Latent
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Positive, run by Holdsworth House Medical Practice at 1 site in Australia.
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 3 inclusion and 0 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 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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.
What does the primary outcome measure?
resistance profiling and subsequent prescription patterns of patients on NNRTIs (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 21 Sep 2015.