Clinical trial 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Cardiovascular Disease
Keywords: HIV
cardiovascular disease
post prandial lipids
ritonavir
darunavir
raltegravir
arterial stiffness
tonometry
Lead sponsor: St Vincent's Hospital, Sydney
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-12-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: safety
timeFrame: 24 weeks
measure: Other metabolic parameters
timeFrame: 24 weeks
measure: Arterial stiffness
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent Hospital, Clinical Research Program
state: New South Wales
Study officials:
affiliation: St Vincent's Hospital - Sydney, Australia
name: Andrew D Carr, Professor
role: PRINCIPAL_INVESTIGATOR
References: