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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-07-31

Brief Summary

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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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Detailed Description

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Conditions

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HIV Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.Raltegravir plus truvada

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

Group Type ACTIVE_COMPARATOR

Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)

Intervention Type 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

2. ritonavir boosted darunavir plus truvada

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

Group Type ACTIVE_COMPARATOR

raltegravir plus truvada

Intervention Type DRUG

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

Interventions

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raltegravir plus truvada

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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tenofovir disoproxil fumarate Isentress Prezista Norvir Tenofovir/emtricitabine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No