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

NCT01258439 | Completed Phase 4 DMC

• 1 other identifier: ROaR+
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Cardiovascular Disease

Keywords

HIV; cardiovascular disease; post prandial lipids; ritonavir; darunavir; raltegravir; arterial stiffness; tonometry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• safety

  24 weeks

• Other metabolic parameters

  24 weeks

• Arterial stiffness

  24 weeks

Study Arms (2)

1.Raltegravir plus truvada

ACTIVE COMPARATOR

Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks

Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)

2. ritonavir boosted darunavir plus truvada

ACTIVE COMPARATOR

Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks

Drug: raltegravir plus truvada

Interventions

raltegravir plus truvada DRUG

raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks

Also known as: tenofovir disoproxil fumarate, Isentress

2. ritonavir boosted darunavir plus truvada

Darunavir, ritonavir, tenofovir/emtricitabine (Truvada) DRUG

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

Also known as: Prezista, Norvir, Tenofovir/emtricitabine

1.Raltegravir plus truvada

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

St Vincent Hospital, Clinical Research Program

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir; Darunavir; Ritonavir; Emtricitabine

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Sulfonamides; Amides; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Thiazoles; Azoles

Study Officials

• Andrew D Carr, Professor

  St Vincent's Hospital - Sydney, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Clinical Research Program

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 13, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01

Locations

AU (2)