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Completed

NCT Number: NCT01258439

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.

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Key information

Conditions

HIV Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Holdsworth House Medical Practice, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir plus truvada

Drug

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

Other names: tenofovir disoproxil fumarate, Isentress

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

Other names: Prezista, Norvir, Tenofovir/emtricitabine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital, Sydney

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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.

Acronym: ROaR+

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2010
Registry last updated
Jan 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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