HIV InfectionsNCT00168233
Impact of HIV and Its Treatment on Reverse Cholesterol Transport
An observational study of HIV Infections, run by The Alfred at 1 site in Australia.
Trial summary
To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport, endothelial function and intima-media thickness in HIV patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- How many people
- 44 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2005to Mar 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected patients naive to ARV therapy
Who may be able to join
- Male patients with HIV infection (3 groups of 50 patients each)
- HIV infected patients, naïve to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months)
- HIV-infected patients, PI naïve, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen)
- HIV-infected patients naïve to ARV therapy, initiating NNRTI-containing regimen
Who cannot join
- Treatment with any form of lipid lowering drugs, including fish oils.
- Body Mass Index greater than 27.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Alfred Hospital and Baker Heart Research Institute
Melbourne, Victoria, 3004
About this study
Official title: Impact of HIV Infection and Treatment With Highly Active Antiretroviral Therapy on Reverse Cholesterol Transport
To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport, endothelial function and intima-media thickness in HIV patients.
- Conditions
- HIV Infections
- Keywords
- Treatment Naive, HIV
- Medical subject headings
- HIV Infections
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 |
|---|---|---|
| 1 | No antiretroviral therapy for 12 months | |
| 2 | Initiating ARV therapy with an NNRTI based regimen | |
| 3 | Initiating ARV therapy with a PI based regimen |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2010
- Study completionMar 2011
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Jennifer Hoy, The Alfred
- Investigators
- Dmitri Sviridov, Dr, Study director, Baker Heart Research Institute, Commercial Road, MelbourneJennifer Hoy, A/Prof, Principal investigator, Alfred Hospital, Melbourne, Vic 3004
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168233
- Sponsor's protocol ID
- 54/05
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2005
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HIV Infection and Treatment With Highly Active Antiretroviral Therapy on Reverse Cholesterol Transport
- ClinicalTrials.gov ID
- NCT00168233
- Acronym / sponsor ID
- 54/05
- Conditions
- HIV Infections
- Keywords
- Treatment Naive, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Jun 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Sep 2005 (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.
To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport, endothelial function and intima-media thickness in HIV patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –No antiretroviral therapy for 12 months |
| 2 | – | –Initiating ARV therapy with an NNRTI based regimen |
| 3 | – | –Initiating ARV therapy with a PI based regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients naive to ARV therapy
Key inclusion criteria (4 listed)
- Male patients with HIV infection (3 groups of 50 patients each)
- HIV infected patients, naïve to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months)
- HIV-infected patients, PI naïve, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen)
- HIV-infected patients naïve to ARV therapy, initiating NNRTI-containing regimen
Key exclusion criteria (2 listed)
- Treatment with any form of lipid lowering drugs, including fish oils.
- Body Mass Index greater than 27.
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 20 Jan 2012.
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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.
Dmitri Sviridov, Dr study director
Baker Heart Research Institute, Commercial Road, Melbourne
Jennifer Hoy, A/Prof principal investigator
Alfred Hospital, Melbourne, Vic 3004
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 Infections, run by The Alfred 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 4 inclusion and 2 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 20 Jan 2012. 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.
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 20 Jan 2012.