Trial Outcomes & Findings for Elite Controller and ART-treated HIV+ Statin Versus ASA Treatment Intervention Study (NCT NCT02081638)
NCT ID: NCT02081638
Last Updated: 2020-12-29
Results Overview
sCD14 change between baseline (average of month 0 and month 3 in the study) and month 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Month 12
Results posted on
2020-12-29
Participant Flow
Participant milestones
| Measure |
Daily Aspirin
HIV Infected on ART
HIV Infected off ART
|
Daily Lipitor
HIV Infected on ART
HIV infected off ART
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Elite Controller and ART-treated HIV+ Statin Versus ASA Treatment Intervention Study
Baseline characteristics by cohort
| Measure |
Daily Aspirin
n=24 Participants
HIV Infected on ART
Elite controllers not on ART
|
Daily Atorvastatin
n=20 Participants
HIV Infected on ART
Elite controllers not on ART
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
54 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 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
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
CD4
|
595 cells/μL
n=5 Participants
|
717 cells/μL
n=7 Participants
|
650 cells/μL
n=5 Participants
|
|
Total Cholesterol
|
174 mg/dL
n=5 Participants
|
173 mg/dL
n=7 Participants
|
173 mg/dL
n=5 Participants
|
|
Hypertension
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12sCD14 change between baseline (average of month 0 and month 3 in the study) and month 12
Outcome measures
| Measure |
Daily Aspirin
n=24 Participants
HIV Infected on ART
Elite controllers not on ART
|
Daily Atorvastatin
n=20 Participants
HIV Infected on ART
Elite controllers not on ART
|
Daily Atorvastatin on ART
Treated Individuals on Chronic Antiretroviral Therapy
|
Daily Atorvastatin Not on ART
Elite controllers not on Chronic Antiretroviral Therapy
|
|---|---|---|---|---|
|
Changes in sCD14 After 9 Months of Treatment With Aspirin or Atorvastatin
|
-0.131 pg/mL
Interval -0.417 to -0.032
|
-0.09 pg/mL
Interval -0.528 to 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12sCD14 change between baseline (average of month 0 and month 3 in the study) and month 12
Outcome measures
| Measure |
Daily Aspirin
n=15 Participants
HIV Infected on ART
Elite controllers not on ART
|
Daily Atorvastatin
n=9 Participants
HIV Infected on ART
Elite controllers not on ART
|
Daily Atorvastatin on ART
n=12 Participants
Treated Individuals on Chronic Antiretroviral Therapy
|
Daily Atorvastatin Not on ART
n=8 Participants
Elite controllers not on Chronic Antiretroviral Therapy
|
|---|---|---|---|---|
|
Changes in sCD14 in EC and ART <50 Groups Treated With Aspirin or Atorvastatin.
|
-0.1249 pg/mL
Interval -0.6963 to 0.1367
|
-0.1353 pg/mL
Interval -0.417 to 0.005
|
-0.3242 pg/mL
Interval -0.79 to -0.004
|
0.1758 pg/mL
Interval -0.17 to 0.698
|
Adverse Events
Daily Aspirin
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Daily Atorvastatin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daily Aspirin
n=24 participants at risk
HIV Infected on ART
Elite controllers not on Chronic Antiretroviral Therapy
|
Daily Atorvastatin
n=23 participants at risk
HIV Infected on ART
Elite controllers not on Chronic Antiretroviral Therapy
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
Other adverse events
| Measure |
Daily Aspirin
n=24 participants at risk
HIV Infected on ART
Elite controllers not on Chronic Antiretroviral Therapy
|
Daily Atorvastatin
n=23 participants at risk
HIV Infected on ART
Elite controllers not on Chronic Antiretroviral Therapy
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected for 3 months after the end of the drug.
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Investigations
Low density lipoprotein increased
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Investigations
Blood cholesterol increased
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected for 3 months after the end of the drug.
|
8.7%
2/23 • Number of events 2 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
4/24 • Number of events 4 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Infections and infestations
Gastroenteritis
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Vascular disorders
Deep vein thrombosis
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Infections and infestations
Gonorrhea
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Investigations
White Blood Cell Decreased
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Investigations
Blood Creatinine Increase
|
12.5%
3/24 • Number of events 3 • Adverse event data were collected for 3 months after the end of the drug.
|
0.00%
0/23 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/24 • Adverse event data were collected for 3 months after the end of the drug.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected for 3 months after the end of the drug.
|
Additional Information
Dr. Irini Sereti
National Institute of Allergy and Infectious Diseases
Phone: 301-496-5533
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place