HIVPhase 4ROaR+NCT01258439

Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.

A Phase 4 study testing raltegravir plus truvada and Darunavir, ritonavir, tenofovir/emtricitabine (Truvada) in people with HIV and Cardiovascular Disease, run by St Vincent's Hospital, Sydney at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, Cardiovascular Disease
What is being tested?: raltegravir plus truvada and Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesAustralia
Study dates: Nov 2010to Jul 2014
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

Provision of signed, informed consent
Age >18 years
HIV infection documented by HIV antibody test and Western Blot prior to study entry
No previous ART OR no ART for 6 months prior to randomisation
CD4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
No genotypic resistance to Raltegravir, Tenofovir/emtricitabine, Darunavir, Ritonavir
Body mass index less than 30kg/m2

Who cannot join

Primary HIV infection within the last 6 months
Active infection or opportunistic illness within the previous 30 days
Use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
Use of lipid-lowering therapy
Diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
Use of oral prednisolone > 7.5mg daily or equivalent
pregnancy or Breast feeding
proven hypersensitivity to one or more components of the study meal

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Holdsworth House Medical Practice
Sydney, New South Wales, 2010
St Vincent Hospital, Clinical Research Program
Sydney, New South Wales, 2010

Other trials in Australia

About this study

Official title: Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART.

This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats.

Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.

Conditions: HIV, Cardiovascular Disease
Being tested: raltegravir plus truvada, Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
Keywords: HIV, cardiovascular disease, post prandial lipids, ritonavir, darunavir, raltegravir, arterial stiffness, tonometry
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

raltegravir plus truvadaDrug
Also called tenofovir disoproxil fumarate, Isentress
raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks
Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)Drug
Also called Prezista, Norvir, Tenofovir/emtricitabine
Darunavir two 400mg tablets with one ritonavir 100mg capsule once daily plus Tenofovir/emtricitabine (Truvada) one 300mg/200mg tablet once daily with food for 24 weeks

Study groups in NCT01258439
Study group	Role	What they receive
1.Raltegravir plus truvada	Active comparator	Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks Receives: Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
2. ritonavir boosted darunavir plus truvada	Active comparator	Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks Receives: Drug: raltegravir plus truvada

What is being measured

The primary outcome is the main question the study is designed to answer.

To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks
Fasting samples will be taken for total cholesterol, LDL and HDL cholesterol, and triglycerides. Repeat lipid samples will be collected before a high fat meal is consumed. After the meal is completed , blood will be collected at 1, 2, 3, and 4 hours at baseline, week 4 and week 24 visits.
Measured: 24 weeks

Secondary outcomes (3)

safety
Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio
Measured: 24 weeks
Other metabolic parameters
Fasting metabolic parameters will be assessed. Study staff and participants will be blinded to the results fo these tests until completion of the study or parameters become sginificantly abnormal
Measured: 24 weeks
Arterial stiffness
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Jul 2014

First posted13 Dec 2010 (estimated)
Study startNov 2010
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies 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: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01258439
Sponsor's protocol ID: ROaR+
Acronym: ROaR+
Status last verified: Jan 2015
First submitted: 9 Dec 2010
Last updated: 12 Jan 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART.
ClinicalTrials.gov ID: NCT01258439
Acronym / sponsor ID: ROaR+ / ROaR+
Conditions: HIV, Cardiovascular Disease
Keywords: HIV, cardiovascular disease, post prandial lipids, ritonavir, darunavir, raltegravir, arterial stiffness, tonometry
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: St Vincent's Hospital, SydneyUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Nov 2010
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 13 Dec 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.

Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1.Raltegravir plus truvada	Active comparator	Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks
2. ritonavir boosted darunavir plus truvada	Active comparator	Drug: raltegravir plus truvadaDarunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provision of signed, informed consent
Age >18 years
HIV infection documented by HIV antibody test and Western Blot prior to study entry
No previous ART OR no ART for 6 months prior to randomisation
CD4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation

Key exclusion criteria (8 listed)

Primary HIV infection within the last 6 months
Active infection or opportunistic illness within the previous 30 days
Use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
Use of lipid-lowering therapy
Diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)

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
raltegravir plus truvadaAlso: tenofovir disoproxil fumarate, Isentressraltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks	Drug	2. ritonavir boosted darunavir plus truvada
Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)Also: Prezista, Norvir, Tenofovir/emtricitabineDarunavir two 400mg tablets with one ritonavir 100mg capsule once daily plus Tenofovir/emtricitabine (Truvada) one 300mg/200mg tablet once daily with food for 24 weeks	Drug	1.Raltegravir plus truvada

Primary outcome

To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks
Time frame: 24 weeks
Fasting samples will be taken for total cholesterol, LDL and HDL cholesterol, and triglycerides. Repeat lipid samples will be collected before a high fat meal is consumed. After the meal is completed , blood will be collected at 1, 2, 3, and 4 hours at baseline, week 4 and week 24 visits.

3 secondary outcomes

safety
Time frame: 24 weeks
Other metabolic parameters
Time frame: 24 weeks
Arterial stiffness
Time frame: 24 weeks

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 12 Jan 2015.

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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, Professor principal investigator

St Vincent's Hospital - Sydney, Australia

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 8 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 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01258439.

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 12 Jan 2015.