Post-parandial lipid effects of MK-0518 (raltegaravir) vs low-dose ritonavir (100mg daily) in HIV-negative adults

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000622404

Acronym

RoaR

Enrollment

Registered

2007-12-05

Start date

2008-06-26

Completion date

2009-03-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A randomized, open-label, 4 week trial. Twenty (22) eligible participants will be randomly assigned to receive 1:1 to raltegravir 400mg bid or ritonavir 100mg mane with food. Planned sample size: Twenty two (22) eligible participants.

Interventions

To compare the effects of oral dose ritonavir (RTV) 100mg daily for 28 days to oral dose raltegravir 400mg twice a day for 28 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. adults taking a 'normal diet' with a stable weight and no desire to lose or gain weight body mass index between 20and 30kg/m2

Exclusion criteria

1. HIV infection 2.use of any medication contra-indictaed with RTG or RTV 3. Fsting triglycerides < 2.0 mmol/l (176 mg/dl) 4. Fasting total cholestrol <6.0 mmol/l (233 mg/dl) 5. use of lipid-lowering therapy 6. Use of anti-hypertensive therapy 7. Diabetes mellitus (fsting glucose >7.0 mmol/l or a prior diagnosis of diabetes) 8. serum hepatic transaminases (AST/ALT) greater than 3 times the upper limit of normal 9. pregnancy or breast feeding

Outcome results