Trial Outcomes & Findings for Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels (NCT NCT01935674)
NCT ID: NCT01935674
Last Updated: 2025-07-16
Results Overview
The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
12 weeks from baseline (week 0 to week 12)
Results posted on
2025-07-16
Participant Flow
Participants were recruited between June 2012 and April 2014 across nine clinical sites in Australia and Spain, including hospitals and private HIV clinics. Recruitment targeted HIV-1-infected adults with controlled viral load and elevated cardiovascular risk, not currently on lipid-lowering therapy.
After providing informed consent, participants underwent a screening period of up to 14 days to confirm eligibility. This included fasting blood tests, cardiovascular risk assessment (Framingham score), and confirmation of stable ART. Participants were excluded prior to randomization if they did not meet inclusion criteria (e.g., cholesterol \<5.5 mmol/L, low cardiovascular risk, or contraindications to study drugs). No washout or run-in period was required.
Participant milestones
| Measure |
Switch Ritonavir-boosted PI
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
|
Continue Ritonavir-boosted PI+Rosuvastatin
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
23
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
Baseline characteristics by cohort
| Measure |
PI/r Switch Group
n=20 Participants
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
|
Rosuvastatin
n=23 Participants
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
53 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
55 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Total cholesterol
|
6.0 mmol/L
STANDARD_DEVIATION 0.9 • n=5 Participants
|
6.3 mmol/L
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.2 mmol/L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from baseline (week 0 to week 12)The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis.
Outcome measures
| Measure |
PI/r Switch Group
n=20 Participants
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
|
Rosuvastatin
n=23 Participants
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
|
|---|---|---|
|
Percentage Change From Baseline in Total Cholesterol at 12 Weeks.
|
8.7 Percentage Change (%)
Standard Deviation 10.8
|
21.4 Percentage Change (%)
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening and week 12The Framingham Risk Score is a sex-specific algorithm used to estimate the 10-year risk of developing cardiovascular disease (CVD), including coronary heart disease, stroke, peripheral artery disease, and heart failure. It is based on factors such as age, sex, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for hypertension, smoking status, and diabetes. Scale Title: Framingham 10-Year Cardiovascular Risk Score Minimum Value: 0% Maximum Value: 100% Interpretation: Higher scores indicate a worse outcome, meaning a higher estimated risk of developing cardiovascular disease within 10 years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening and week 12.Outcome measures
Outcome data not reported
Adverse Events
PI/r Switch Group
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Rosuvastatin
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PI/r Switch Group
n=20 participants at risk
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
|
Rosuvastatin
n=23 participants at risk
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
|
|---|---|---|
|
Cardiac disorders
Unstable angina requiring coronary artery stenting
|
0.00%
0/20 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
4.3%
1/23 • Number of events 1 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
|
Musculoskeletal and connective tissue disorders
Tibial fracture
|
5.0%
1/20 • Number of events 1 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
0.00%
0/23 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
Other adverse events
| Measure |
PI/r Switch Group
n=20 participants at risk
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Switch ritonavir-boosted PI: Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
|
Rosuvastatin
n=23 participants at risk
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Continue Ritonavir-boosted PI+Rosuvastatin: Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 4 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
4.3%
1/23 • Number of events 1 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
4/20 • Number of events 4 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
0.00%
0/23 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 2 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
0.00%
0/23 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
0.00%
0/23 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
|
Investigations
Other
|
30.0%
6/20 • Number of events 6 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
0.00%
0/23 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
|
General disorders
Unespecified non drug-related events
|
20.0%
4/20 • Number of events 4 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
56.5%
13/23 • Number of events 13 • 12 weeks
Adverse events were graded according to the Division of AIDS (DAIDS) adverse event grading table \[23\], and assigned causality; participants were directly asked about gastrointestinal and musculoskeletal events. Between-group adverse event rates were compared using the χ² test.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place