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

HIV Clinical Trial

— ROaR+  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258439
• Other study ID #: ROaR+
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2010
• Last updated: January 8, 2015
• Start date: November 2010
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: St Vincent's Hospital, Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• HIV

Intervention

Drug:
• raltegravir plus truvada
raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks
• 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

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	St Vincent Hospital, Clinical Research Program	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
St Vincent's Hospital, Sydney	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks	No
Secondary	safety	Safety parameters will be assessed by measurement of urea and electrolytes, LFTs, urine protein to creatinine ratio	24 weeks	Yes
Secondary	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	24 weeks	No
Secondary	Arterial stiffness		24 weeks	No