Trial Outcomes & Findings for Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy (NCT NCT00367458)
NCT ID: NCT00367458
Last Updated: 2020-02-26
Results Overview
The change in HIV viral RNA level in plasma in response to lipid lowering agents was measured as log10 plasma RNA copy number, and the change in the log10 viral RNA level is included in table.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2020-02-26
Participant Flow
Participant milestones
| Measure |
Atorvastatin First, Then Placebo
Patients were randomized to receive Atorvastatin first for 8 weeks, followed by 4 weeks wash out, and then cross over to placebo for 8 weeks.
|
Placebo First, Then Atorvastatin
Patients were randomized to receive placebo first for 8 weeks, followed by 4 weeks wash out, and then cross over to 80 mg atorvastatin daily for 8 weeks.
|
|---|---|---|
|
First Intervention - 8 Weeks
STARTED
|
12
|
12
|
|
First Intervention - 8 Weeks
COMPLETED
|
10
|
12
|
|
First Intervention - 8 Weeks
NOT COMPLETED
|
2
|
0
|
|
Washout Period - 4-6 Weeks
STARTED
|
10
|
12
|
|
Washout Period - 4-6 Weeks
COMPLETED
|
10
|
12
|
|
Washout Period - 4-6 Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Intervention - 8 Weeks
STARTED
|
10
|
12
|
|
Second Intervention - 8 Weeks
COMPLETED
|
10
|
12
|
|
Second Intervention - 8 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Atorvastatin First, Then Placebo
Patients were randomized to receive Atorvastatin first for 8 weeks, followed by 4 weeks wash out, and then cross over to placebo for 8 weeks.
|
Placebo First, Then Atorvastatin
Patients were randomized to receive placebo first for 8 weeks, followed by 4 weeks wash out, and then cross over to 80 mg atorvastatin daily for 8 weeks.
|
|---|---|---|
|
First Intervention - 8 Weeks
Adverse Event
|
2
|
0
|
Baseline Characteristics
Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy
Baseline characteristics by cohort
| Measure |
Atorvastatin First, Then Placebo
n=12 Participants
Patients were randomized to receive Atorvastatin first for 8 weeks, followed by 4 weeks wash out, and then cross over to placebo for 8 weeks.
|
Placebo First, Then Atorvastatin
n=12 Participants
Patients were randomized to receive placebo first for 8 weeks, followed by 4 weeks wash out, and then cross over to 80 mg atorvastatin daily for 8 weeks.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
n=5 Participants
|
30 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksThe change in HIV viral RNA level in plasma in response to lipid lowering agents was measured as log10 plasma RNA copy number, and the change in the log10 viral RNA level is included in table.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
Patients were randomized to receive Atorvastatin for 8 weeks
|
Placebo
n=24 Participants
Patients were randomized to receive placebo for 8 weeks
|
|---|---|---|
|
Change in Human Immunodeficiency Virus 1 (HIV-1) Ribonucleic Acid (RNA) Levels
Baseline
|
0 Log10 copies/ml plasma
Interval 0.0 to 0.0
|
0 Log10 copies/ml plasma
Interval 0.0 to 0.0
|
|
Change in Human Immunodeficiency Virus 1 (HIV-1) Ribonucleic Acid (RNA) Levels
8 Weeks
|
-0.03 Log10 copies/ml plasma
Interval -0.35 to 0.04
|
-0.08 Log10 copies/ml plasma
Interval -0.25 to 0.08
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksCD4+HLA-DR+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
Patients were randomized to receive Atorvastatin for 8 weeks
|
Placebo
n=24 Participants
Patients were randomized to receive placebo for 8 weeks
|
|---|---|---|
|
Change in Percentage of Cluster of Differentiation 4 (CD4+) Human Leukocyte Antigen DR (HLA-DR+) in Peripheral Blood
Baseline CD4+HLA-DR+
|
0 percent T cell subset
Standard Deviation 5.34
|
0 percent T cell subset
Standard Deviation 7.35
|
|
Change in Percentage of Cluster of Differentiation 4 (CD4+) Human Leukocyte Antigen DR (HLA-DR+) in Peripheral Blood
CD4+HLA-DR+ at 8 Weeks
|
-2 percent T cell subset
Standard Deviation 5.05
|
-1.8 percent T cell subset
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 26 weeks.Here is the count of participants with serious and non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
Patients were randomized to receive Atorvastatin for 8 weeks
|
Placebo
n=24 Participants
Patients were randomized to receive placebo for 8 weeks
|
|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksCD8+HLA-DR+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
Patients were randomized to receive Atorvastatin for 8 weeks
|
Placebo
n=24 Participants
Patients were randomized to receive placebo for 8 weeks
|
|---|---|---|
|
Change in Percentage of Cluster of Differentiation 8 (CD8+) Human Leukocyte Antigen DR (HLA-DR+) in Peripheral Blood
Baseline CD8+HLA-DR+
|
0 percent T cell subset
Standard Deviation 10.28
|
0 percent T cell subset
Standard Deviation 12.52
|
|
Change in Percentage of Cluster of Differentiation 8 (CD8+) Human Leukocyte Antigen DR (HLA-DR+) in Peripheral Blood
CD8+HLA-DR+ at 8 Weeks
|
-3.8 percent T cell subset
Standard Deviation 8.80
|
-3.5 percent T cell subset
Standard Deviation 12.15
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksCD8+HLADR+CD38+ are cellular markers of immune activation that is present in HIV infected individuals. This marker was measured before and after the statin/placebo intervention by standard lymphocyte phenotyping.
Outcome measures
| Measure |
Atorvastatin
n=24 Participants
Patients were randomized to receive Atorvastatin for 8 weeks
|
Placebo
n=24 Participants
Patients were randomized to receive placebo for 8 weeks
|
|---|---|---|
|
Change in Percentage of Cluster of Differentiation 8 (CD8+) Human Leukocyte Antigen DR (HLA-DR+), CD8+(CD8+HLADR+CD38+) in Peripheral Blood
Baseline CD8+HLADR+CD38+
|
0 percent T cell subset
Standard Deviation 12.31
|
0 percent T cell subset
Standard Deviation 11.01
|
|
Change in Percentage of Cluster of Differentiation 8 (CD8+) Human Leukocyte Antigen DR (HLA-DR+), CD8+(CD8+HLADR+CD38+) in Peripheral Blood
CD8+HLADR+CD38+ at 8 Weeks
|
-3.75 percent T cell subset
Standard Deviation 10.37
|
-3.3 percent T cell subset
Standard Deviation 13.28
|
Adverse Events
Atorvastatin
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=24 participants at risk
Patients were randomized to receive Atorvastatin for 8 weeks
|
Placebo
n=24 participants at risk
Patients were randomized to receive placebo for 8 weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
low LDL
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 26 weeks
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 26 weeks
|
Other adverse events
| Measure |
Atorvastatin
n=24 participants at risk
Patients were randomized to receive Atorvastatin for 8 weeks
|
Placebo
n=24 participants at risk
Patients were randomized to receive placebo for 8 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Abscess
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
2/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
3/24 • Number of events 3 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Investigations
Blood bilirubin increased
|
4.2%
1/24 • Number of events 2 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Ear and labyrinth disorders
Ear infection
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Cardiac disorders
Electrocardiogram abnormal
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Skin and subcutaneous tissue disorders
Herpes simplex
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Skin and subcutaneous tissue disorders
Hot flush
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
General disorders
Pain
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Immune system disorders
Seasonal allergy
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Surgical and medical procedures
Supplementation therapy
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
|
Infections and infestations
Treponema test positive
|
4.2%
1/24 • Number of events 1 • Date treatment consent signed to date off study, approximately 26 weeks
|
0.00%
0/24 • Date treatment consent signed to date off study, approximately 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place