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+)
This study is currently recruiting participants.
Verified October 2012 by St Vincent's Hospital, Sydney
Sponsor:
St Vincent's Hospital, Sydney
Collaborator:
Merck
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:
NCT01258439
First received: December 9, 2010
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Cardiovascular Disease |
Drug: raltegravir plus truvada Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Ritonavir
Tenofovir Disoproxil Fumarate
Darunavir
Raltegravir
Darunavir ethanolate
Truvada
Raltegravir potassium
U.S. FDA Resources
Further study details as provided by St Vincent's Hospital, Sydney:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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:
- safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio
- Other metabolic parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258439
Contacts
| Contact: Robyn A Richardson, RN | 61 2 8382-3872 | rrichardson1@stvincents.com.au |
| Contact: Andrew D Carr, Professor | 61 2 8382-3438 | acarr@stvincents.com.au |
Locations
| Australia, New South Wales | |
| St Vincent Hospital, Clinical Research Program | Recruiting |
| Sydney, New South Wales, Australia, 2010 | |
| Contact: Robyn A Richardson, RN 61 2 8382-3872 rrichardson1@stvincents.com.au | |
| Principal Investigator: Andrew D Carr, Professor | |
| Holdsworth House Medical Practice | Recruiting |
| Sydney, New South Wales, Australia, 2010 | |
| Contact: Mark Bloch, Dr +61 2 9331 7228 mbloch@holdsworthhouse.com.au | |
| Principal Investigator: Mark Bloch, Dr | |
Sponsors and Collaborators
St Vincent's Hospital, Sydney
Merck
Investigators
| Principal Investigator: | Andrew D Carr, Professor | St Vincent's Hospital, Sydney, Australia |
More Information
No publications provided
| 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+ |
| Study First Received: | December 9, 2010 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Australia: Therapeutic Goods Administration |
Keywords provided by 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 Tenofovir disoproxil Emtricitabine HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013