HIV InfectionsPhase 4NCT00227500
Pravastatin for Hyperlipidaemia in HIV.
A Phase 4 study testing Pravastatin in people with HIV Infections and Lipid Metabolism, run by Kirby Institute at 1 site in Australia.
Trial summary
This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Lipid Metabolism, Glucose Metabolism
- What is being tested?
- Pravastatin
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2001to Oct 2004
- Phase
- Phase 4
- 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
- Provide written informed consent to participate in the trial
- HIV-1 sero-positive
- Male/female >18 years age
- Currently receiving HIV protease inhibitor therapy for > 12 weeks and unlikely to require change in existing regimen during the 16 week study period
- Fasting cholesterol > 6.5 mmol/L (mean of 2 samples collected > 3 days apart)
Who cannot join
- Any condition which may interfere with ability to comply with study
- Gastrointestinal disorder which may affect drug absorption
- Hypertension or congestive cardiac failure
- Lactic acidemia (serum lactate level >2.2 mmol/L)
- Any serious medical condition which may compromise the patient's safety, including pancreatitis or hepatitis within past 6 months
- Active AIDS defining conditions
- Concurrent therapy with any other lipid lowering agents, oral hypoglycaemics, anabolic steroids or insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV
This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.
Read the detailed description
High serum cholesterol concentrations are commonly seen in HIV-infected patients treated with some protease inhibitor medications as part of long-term antiretroviral therapy for HIV. There is concern that these elevations in cholesterol may negatively impact on long-term risk of cardiovascular disease in this patient population. Pravastatin, a HMG-CoA reductase inhibitor, is commonly used to treat hypercholesterolaemia in the general population. We aim to examine the effect of 12 weeks therapy with 40mg pravastatin daily in conjunction with dietary advice in HIV-infected patients with elevated serum cholesterol on continued protease inhibitor therapy.
After 4 weeks of dietary advice, patients will be randomised to receive either pravastatin or placebo for 12 weeks. Assessments include fasting lipid and glycaemic parameters, measures of body composition and HIV disease, and surrogate markers for cardiovascular disease.
Although previous small studies of pravastatin in this field have been performed, none has done so in a randomised placebo controlled trial taking into account all the relevant measures.
- Conditions
- HIV Infections, Lipid Metabolism, Glucose Metabolism, Metabolic Abnormality, Lipodystrophy, Cardiovascular Disease
- Being tested
- Pravastatin
- Keywords
- Hyperlipidaemia, Lipid metabolism, Glucose metabolism, HMG CoA reductase inhibitors, Lipodystrophy, Cardiovascular disease, Treatment Experienced, HIV
- Medical subject headings
- HIV Infections, Lipodystrophy, Cardiovascular Diseases, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in time weighted change from baseline in fasting serum total cholesterol
Secondary outcomes (1)
Includes: between-group difference in time weighted change: from wk 4 in fasting serum total cholesterol as well as from baseline in HDL-cholesterol and triglycerides; in total and regional body fat; in endothelial function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJul 2001
- Study completionOct 2004
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales, National Heart, Lung, and Blood Institute (NHLBI), Garvan Institute of Medical Research, St Vincent's Hospital, Sydney
- Investigators
- Andrew D Carr, MD, Principal investigator, National Centre in HIV Epidemiology and Clinical Research.David A Cooper, MD, Study director, National Centre in HIV Epidemiology and Clinical Research.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227500
- Sponsor's protocol ID
- PRAVA
- Other IDs
- PRAVA / RO1 HL65953-01
- Status last verified
- Jun 2006
- First submitted
- 27 Sep 2005
- Last updated
- 9 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV
- ClinicalTrials.gov ID
- NCT00227500
- Acronym / sponsor ID
- PRAVA
- Conditions
- HIV Infections, Lipid Metabolism, Glucose Metabolism, Metabolic Abnormality, Lipodystrophy, Cardiovascular Disease
- Keywords
- Hyperlipidaemia, Lipid metabolism, Glucose metabolism, HMG CoA reductase inhibitors, Lipodystrophy, Cardiovascular disease, Treatment Experienced, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales, National Heart, Lung, and Blood Institute (NHLBI), Garvan Institute of Medical Research, St Vincent's Hospital, Sydney
- Study start
- Jul 2001
- Study completion
- Oct 2004
- First posted
- 28 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.
This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.
Detailed description
High serum cholesterol concentrations are commonly seen in HIV-infected patients treated with some protease inhibitor medications as part of long-term antiretroviral therapy for HIV. There is concern that these elevations in cholesterol may negatively impact on long-term risk of cardiovascular disease in this patient population. Pravastatin, a HMG-CoA reductase inhibitor, is commonly used to treat hypercholesterolaemia in the general population. We aim to examine the effect of 12 weeks therapy with 40mg pravastatin daily in conjunction with dietary advice in HIV-infected patients with elevated serum cholesterol on continued protease inhibitor therapy.
After 4 weeks of dietary advice, patients will be randomised to receive either pravastatin or placebo for 12 weeks. Assessments include fasting lipid and glycaemic parameters, measures of body composition and HIV disease, and surrogate markers for cardiovascular disease.
Although previous small studies of pravastatin in this field have been performed, none has done so in a randomised placebo controlled trial taking into account all the relevant measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent to participate in the trial
- HIV-1 sero-positive
- Male/female >18 years age
- Currently receiving HIV protease inhibitor therapy for > 12 weeks and unlikely to require change in existing regimen during the 16 week study period
- Fasting cholesterol > 6.5 mmol/L (mean of 2 samples collected > 3 days apart)
Key exclusion criteria (7 listed)
- Any condition which may interfere with ability to comply with study
- Gastrointestinal disorder which may affect drug absorption
- Hypertension or congestive cardiac failure
- Lactic acidemia (serum lactate level >2.2 mmol/L)
- Any serious medical condition which may compromise the patient's safety, including pancreatitis or hepatitis within past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin | Drug | – |
Primary outcome
Between-group difference in time weighted change from baseline in fasting serum total cholesterol
1 secondary outcome
Includes: between-group difference in time weighted change: from wk 4 in fasting serum total cholesterol as well as from baseline in HDL-cholesterol and triglycerides; in total and regional body fat; in endothelial function
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 9 Jun 2006.
- National Centre in HIV Epidemiology and Clinical Research HomepageLink provided by the sponsor.
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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.
Andrew D Carr, MD principal investigator
National Centre in HIV Epidemiology and Clinical Research.
David A Cooper, MD study director
National Centre in HIV Epidemiology and Clinical Research.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pravastatin in people with HIV Infections and Lipid Metabolism, run by Kirby Institute 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 5 inclusion and 7 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 9 Jun 2006. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Between-group difference in time weighted change from baseline in fasting serum total cholesterol. 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 9 Jun 2006.