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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:
NCT01258439
First received: December 9, 2010
Last updated: April 15, 2014
Last verified: April 2014

December 9, 2010
April 15, 2014
November 2010
August 2014   (final data collection date for primary outcome measure)
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.
Post prandial lipid responses at week 24 compared to baseline [ Time Frame: Lipid pathology will be compared at Week 24 to baseline. ] [ 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.
Complete list of historical versions of study NCT01258439 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Cardiovascular Disease
  • Drug: raltegravir plus truvada
    raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks
    Other Names:
    • tenofovir disoproxil fumarate
    • Isentress
  • 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: 1.Raltegravir plus truvada
    Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks
    Intervention: Drug: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)
  • Active Comparator: 2. ritonavir boosted darunavir plus truvada
    Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks
    Intervention: Drug: raltegravir plus truvada
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01258439
ROaR+
Yes
Andrew Carr, St Vincent's Hospital, Sydney
St Vincent's Hospital, Sydney
Merck Sharp & Dohme Corp.
Principal Investigator: Andrew D Carr, Professor St Vincent's Hospital, Sydney, Australia
St Vincent's Hospital, Sydney
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP