Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients

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University of British Columbia

Status and phase

Terminated
Phase 4

Conditions

HIV Infections
Atherosclerosis

Treatments

Drug: Placebo
Drug: Rosuvastatin

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT00673582
H07-00213
D3560L00059

Details and patient eligibility

About

Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. We expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.

Full description

HIV+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. B-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. We hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.

Enrollment

250 estimated patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV positive, at least one cardiovascular disease risk factor

Exclusion criteria

  • Diabetes
  • Previous vascular disease
  • Muscular disease
  • Current use of other lipid lowering therapy

Trial design

250 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
10 mg/day rosuvastatin for 96 weeks
Treatment:
Drug: Rosuvastatin
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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