NCT01813357

Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

Completed Phase 4 Results posted Last updated 28 August 2020

What this trial tests

Phase 4 trial testing Rosuvastatin in HIV in 84 participants. Completed in 1 November 2018.

Timeline

2 July 2013

Primary endpoint
17 May 2018

1 November 2018

Quick facts

Lead sponsor	Bayside Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	84
Start date	2 July 2013
Primary completion	17 May 2018
Estimated completion	1 November 2018
Sites	2 locations across Switzerland, Australia

Drugs / interventions tested

• Rosuvastatin (rosuvastatin) — full drug profile →
• Placebo

Conditions studied

• HIV — all drugs for HIV →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

Bayside Health — full company profile →

Who can join

Adults 18 to 100, any sex, with HIV or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression of Carotid Intima Media Thickness Primary · Baseline to week 96

Carotid intima media thickness will be measured by ultrasonography and the change from baseline to week 96 calculated

Group	Value	95% CI
Placebo	0.0062	± 0.0039
Rosuvastatin	0.004	± 0.0036

Rates of Adverse Events Secondary · Will be assessed every 12 weeks and formally reported at 96 weeks of followup

Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication

Group	Value	95% CI
Placebo	22
Rosuvastatin	35

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 6/40 (15%)

Deaths: 0/40

Rosuvastatin

Serious: 7/44 (16%)

Deaths: 1/44

Serious adverse events (11 terms)

Reaction	System	Placebo	Rosuvastatin
Acute myocardial infarction	Cardiac disorders	—	—
Type two diabetes	Endocrine disorders	—	—
Stroke	Nervous system disorders	—	—
elevated creatinine kinase	Musculoskeletal and connective tissue disorders	—	—
Heart Failure	Cardiac disorders	—	—
Elevated Alanine aminotransferase (ALT)	Hepatobiliary disorders	—	—
Hypertension	Vascular disorders	—	—
Acute Mesentric Ischaemia	Vascular disorders	—	—
Oesophageal Malignancy	Gastrointestinal disorders	—	—
Lumbar vertebral disc herniation	Musculoskeletal and connective tissue disorders	—	—
Haemoptysis	Gastrointestinal disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Placebo	Rosuvastatin
ALT elevation	Hepatobiliary disorders	—	—
Hypertension	Cardiac disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Non-specific gastrointestinal disturbance	Gastrointestinal disorders	—	—
CK elevation	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Acute myocardial infarction, Type two diabetes, Stroke, elevated creatinine kinase, Heart Failure, Elevated Alanine aminotransferase (ALT), Hypertension, Acute Mesentric Ischaemia.

Data from ClinicalTrials.gov NCT01813357 adverse events section.

Sponsor's own description

This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk.

It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. Current Australian guidelines recommend initiation of statin therapy on the basis of cholesterol level and the presence of other risk factors for heart disease (such as diabetes) but do not take into account whether a patient is infected with HIV. This study aims to determine what benefit HIV infected people will receive from starting statin therapy earlier then currently recommended.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune activation and cardiovascular disease in chronic HIV infection.
   Longenecker CT, Sullivan C, Baker JV. · · 2016 · cited 85× · PMID 26599166 · DOI 10.1097/coh.0000000000000227
2. What happens to cardiovascular system behind the undetectable level of HIV viremia?
   d'Ettorre G, Ceccarelli G, Pavone P, Vittozzi P, et al · · 2016 · cited 27× · PMID 27127532 · DOI 10.1186/s12981-016-0105-z
3. Statins to improve cardiovascular outcomes in treated HIV infection.
   Longenecker CT, Eckard AR, McComsey GA. · · 2016 · cited 25× · PMID 26658651 · DOI 10.1097/qco.0000000000000223
4. Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk: a randomised, controlled trial.
   Trevillyan JM, Dart A, Paul E, Cavassini M, et al · · 2021 · cited 7× · PMID 33252480 · DOI 10.1097/qad.0000000000002764