Trial Outcomes & Findings for Does Rosuvastatin Delay Progression of Atherosclerosis in HIV (NCT NCT01813357)

NCT ID: NCT01813357

Last Updated: 2020-08-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 84 participants
• Primary outcome timeframe: Baseline to week 96
• Results posted on: 2020-08-28

Participant Flow

Participant milestones

Measure	Placebo sugar pill that is encapsulated so as to appear identical to the active agent Placebo: Placebo arm included to maintain blinding	Rosuvastatin Rosuvastatin 20mg daily Rosuvastatin: encapsulated tablet 20mg daily
Overall Study STARTED	40	44
Overall Study COMPLETED	35	38
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Placebo sugar pill that is encapsulated so as to appear identical to the active agent Placebo: Placebo arm included to maintain blinding	Rosuvastatin Rosuvastatin 20mg daily Rosuvastatin: encapsulated tablet 20mg daily
Overall Study Lost to Follow-up	5	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=40 Participants Participants received daily placebo	Active n=44 Participants Participants received daily rosuvastatin	Total n=84 Participants Total of all reporting groups
Age, Continuous	54.4 years STANDARD_DEVIATION 6.4 • n=40 Participants	53.9 years STANDARD_DEVIATION 5.9 • n=44 Participants	54.1 years STANDARD_DEVIATION 6.3 • n=84 Participants
Sex: Female, Male Female	0 Participants n=40 Participants	2 Participants n=44 Participants	2 Participants n=84 Participants
Sex: Female, Male Male	40 Participants n=40 Participants	42 Participants n=44 Participants	82 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Australia	27 participants n=40 Participants	28 participants n=44 Participants	55 participants n=84 Participants
Region of Enrollment Switzerland	13 participants n=40 Participants	16 participants n=44 Participants	29 participants n=84 Participants
Current Smoker	12 Participants n=40 Participants	16 Participants n=44 Participants	28 Participants n=84 Participants
Total cholesterol	5.3 mmol/L STANDARD_DEVIATION 1.1 • n=40 Participants	5.4 mmol/L STANDARD_DEVIATION 0.8 • n=44 Participants	5.3 mmol/L STANDARD_DEVIATION 1.0 • n=84 Participants
Duration HIV infection	13.6 years STANDARD_DEVIATION 7.7 • n=40 Participants	17.2 years STANDARD_DEVIATION 8.5 • n=44 Participants	16 years STANDARD_DEVIATION 7.9 • n=84 Participants
Current cluster of differentiation of 4 (CD4) Cell count	550 cells/ul STANDARD_DEVIATION 254 • n=40 Participants	693 cells/ul STANDARD_DEVIATION 259 • n=44 Participants	590 cells/ul STANDARD_DEVIATION 250 • n=84 Participants

PRIMARY outcome

Timeframe: Baseline to week 96

Population: Intention to treat

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

Outcome measures

Measure	Placebo n=40 Participants sugar pill that is encapsulated so as to appear identical to the active agent Placebo: Placebo arm included to maintain blinding	Rosuvastatin n=44 Participants Rosuvastatin 20mg daily Rosuvastatin: encapsulated tablet 20mg daily
Progression of Carotid Intima Media Thickness	0.0062 mm Standard Error 0.0039	0.004 mm Standard Error 0.0036

SECONDARY outcome

Timeframe: Will be assessed every 12 weeks and formally reported at 96 weeks of followup

Population: Intention to treat population

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

Outcome measures

Measure	Placebo n=40 Participants sugar pill that is encapsulated so as to appear identical to the active agent Placebo: Placebo arm included to maintain blinding	Rosuvastatin n=44 Participants Rosuvastatin 20mg daily Rosuvastatin: encapsulated tablet 20mg daily
Rates of Adverse Events	22 Participants	35 Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 29 other events

Deaths: 0 deaths

Rosuvastatin

Serious events: 7 serious events

Other events: 36 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo n=40 participants at risk sugar pill that is encapsulated so as to appear identical to the active agent Placebo: Placebo arm included to maintain blinding	Rosuvastatin n=44 participants at risk Rosuvastatin 20mg daily Rosuvastatin: encapsulated tablet 20mg daily
Nervous system disorders Stroke	0.00% 0/40 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	2.3% 1/44 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Cardiac disorders Acute myocardial infarction	2.5% 1/40 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	4.5% 2/44 • Number of events 2 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Musculoskeletal and connective tissue disorders elevated creatinine kinase	0.00% 0/40 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	2.3% 1/44 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Endocrine disorders Type two diabetes	0.00% 0/40 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	4.5% 2/44 • Number of events 2 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Cardiac disorders Heart Failure	0.00% 0/40 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	2.3% 1/44 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Hepatobiliary disorders Elevated Alanine aminotransferase (ALT)	2.5% 1/40 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	2.3% 1/44 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Vascular disorders Hypertension	0.00% 0/40 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	2.3% 1/44 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Vascular disorders Acute Mesentric Ischaemia	2.5% 1/40 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	0.00% 0/44 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Gastrointestinal disorders Oesophageal Malignancy	2.5% 1/40 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	0.00% 0/44 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Musculoskeletal and connective tissue disorders Lumbar vertebral disc herniation	2.5% 1/40 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	0.00% 0/44 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Gastrointestinal disorders Haemoptysis	2.5% 1/40 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	0.00% 0/44 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used

Other adverse events

Measure	Placebo n=40 participants at risk sugar pill that is encapsulated so as to appear identical to the active agent Placebo: Placebo arm included to maintain blinding	Rosuvastatin n=44 participants at risk Rosuvastatin 20mg daily Rosuvastatin: encapsulated tablet 20mg daily
Musculoskeletal and connective tissue disorders Myalgia	17.5% 7/40 • Number of events 7 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	2.3% 1/44 • Number of events 1 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Musculoskeletal and connective tissue disorders CK elevation	7.5% 3/40 • Number of events 3 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	9.1% 4/44 • Number of events 4 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Hepatobiliary disorders ALT elevation	10.0% 4/40 • Number of events 4 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	29.5% 13/44 • Number of events 13 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Gastrointestinal disorders Non-specific gastrointestinal disturbance	10.0% 4/40 • Number of events 4 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	11.4% 5/44 • Number of events 5 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used
Cardiac disorders Hypertension	27.5% 11/40 • Number of events 11 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used	29.5% 13/44 • Number of events 13 • Adverse event (AE) data was collected during study involvement and for 144 weeks post completion of last study visit (up to 240 weeks). Standard definitions used

Additional Information

Dr Janine Trevillyan

Monash University and Alfred Health

Phone: 03 90762000

Email: janine.trevillyan@monash.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place