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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. Identifier: NCT01258439
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : January 12, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital, Sydney

Brief Summary:

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

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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:
  • Prezista
  • Norvir
  • Tenofovir/emtricitabine

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:
  • tenofovir disoproxil fumarate
  • Isentress

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. safety [ Time Frame: 24 weeks ]
    Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio

  2. 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

  3. Arterial stiffness [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01258439

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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
Sponsors and Collaborators
St Vincent's Hospital, Sydney
Merck Sharp & Dohme Corp.
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Principal Investigator: Andrew D Carr, Professor St Vincent's Hospital - Sydney, Australia
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Responsible Party: Andrew Carr, Head, Clinical Research Program, St Vincent's Hospital, Sydney Identifier: NCT01258439    
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:
cardiovascular disease
post prandial lipids
arterial stiffness
Additional relevant MeSH terms:
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Cardiovascular Diseases
Raltegravir Potassium
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