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+)

Study Description

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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

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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.

Investigators

Principal Investigator:	Andrew D Carr, Professor	St Vincent's Hospital, Sydney, Australia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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