Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART. (ROaR+)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01258439 |
Recruitment Status
:
Completed
First Posted
: December 13, 2010
Last Update Posted
: January 12, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Cardiovascular Disease | Drug: raltegravir plus truvada Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1.Raltegravir plus truvada
Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks
|
Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
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
Other Names:
|
Active Comparator: 2. ritonavir boosted darunavir plus truvada
Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks
|
Drug: raltegravir plus truvada
raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks
Other Names:
|
- 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.
- safety [ Time Frame: 24 weeks ]Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio
- Other metabolic parameters [ Time Frame: 24 weeks ]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
- Arterial stiffness [ Time Frame: 24 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258439
Australia, New South Wales | |
Holdsworth House Medical Practice | |
Sydney, New South Wales, Australia, 2010 | |
St Vincent Hospital, Clinical Research Program | |
Sydney, New South Wales, Australia, 2010 |
Principal Investigator: | Andrew D Carr, Professor | St Vincent's Hospital, Sydney, Australia |
Responsible Party: | Andrew Carr, Head, Clinical Research Program, St Vincent's Hospital, Sydney |
ClinicalTrials.gov Identifier: | NCT01258439 History of Changes |
Other Study ID Numbers: |
ROaR+ |
First Posted: | December 13, 2010 Key Record Dates |
Last Update Posted: | January 12, 2015 |
Last Verified: | January 2015 |
Keywords provided by Andrew Carr, St Vincent's Hospital, Sydney:
HIV cardiovascular disease post prandial lipids ritonavir |
darunavir raltegravir arterial stiffness tonometry |
Additional relevant MeSH terms:
Cardiovascular Diseases Ritonavir Darunavir Tenofovir Raltegravir Potassium Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors HIV Integrase Inhibitors Integrase Inhibitors |