Post-prandial lipid effects of ritonavir-boosted atazanavir vs ritonavir-boosted darunavir in HIV-uninfected adults

To compare the effects of ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg once daily) to ritonavir-boosted darunavir (DRV 800mg / RTV 100mg once daily) over 4 weeks on postprandial lipids in healthy volunteers.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000917033

Acronym

rAD

Enrollment

Registered

2010-10-28

Start date

2010-10-12

Completion date

2011-11-01

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

This is a randomized, open-label, 4-week trial. Twenty (20) eligible participants will be randomly allocated 1:1 to receive: i) ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg) once daily for four (4) weeks OR ii) ritonavir-boosted darunavir (DRV 800mg / RTV 100mg) once daily for four (4) weeks Planned sample size: Twenty (20) eligible participants who complete the 4 week study

Interventions

To compare the effects of oral ritonavir-boosted atazanavir (AZV 300mg / RTV 100mg once daily) to oral ritonavir-boosted darunavir (DRV 800mg / RTV 100mg once daily) over 4 weeks.

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.Provision of signed, informed consent 2.Adults taking their “normal diet” (stable intake for each participant) with a stable weight and no desire to lose or gain weight 3.Body mass index between 20 and 30 kg/m2 4.Fasting triglycerides < 2.0 mmol/l 5.Fasting total cholesterol < 6.0 mmol/l

Exclusion criteria

6.HIV infection (antibody, western blot, proviral DNA) 7.Use of any medication contra-indicated with RTV, AZV or DRV 8.Use of lipid-lowering therapy 9.Use of anti-hypertensive therapy 10.Diabetes mellitus (fasting glucose > 7.0 mmol/l or a prior diagnosis of diabetes) 11.Serum hepatic transaminases (ALT / AST) greater than 3 times the upper limit of normal 12.Pregnancy or breast feeding

Outcome results