Trial Outcomes & Findings for Atorvastatin for HAART Suboptimal Responders (NCT NCT01766076)
NCT ID: NCT01766076
Last Updated: 2015-05-21
Results Overview
Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-05-21
Participant Flow
30 participants were recruited from the Infectious Diseases Institute research cohort (single site) and followed up for 12 weeks, 4 weeks wash out period and 12 weeks after cross over of treatment assignment
Participants were selected if they had sustained viral suppression for 7 years and CD4 increases below 300 cells/ul
Participant milestones
| Measure |
Atorvastatin First, Then Placebo
Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC were collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry
|
Placebo First, Then Atorvastatin
Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atorvastatin for HAART Suboptimal Responders
Baseline characteristics by cohort
| Measure |
Atorvastatin First, Then Placebo
n=15 Participants
Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC will be collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry
|
Placebo First, Then Atorvastatin
n=15 Participants
Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry
|
Total
n=30 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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 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
|
41 years
n=5 Participants
|
47 years
n=7 Participants
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
CD4 T-cell activation
|
4.2 percenatage of activated CD4 T-cells
n=5 Participants
|
2.9 percenatage of activated CD4 T-cells
n=7 Participants
|
4.2 percenatage of activated CD4 T-cells
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: There was no cross-over or carry-over effect (the sequence did not matter), so we present data for 30 patients for their 12 weeks exposure to atorvastatin
Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated
Outcome measures
| Measure |
Atorvastatin
n=30 Participants
Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC were collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry
|
Placebo
n=30 Participants
Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry
|
|---|---|---|
|
Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily
|
60 percentage change in activated T-cells
Interval 50.0 to 68.0
|
21 percentage change in activated T-cells
Interval 2.0 to 31.0
|
Adverse Events
Atorvastatin First, Then Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo First, Then Atorvastatin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin First, Then Placebo
n=15 participants at risk
Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.
PBMC were collected for immune activation assays using flowcytometry
'atorvastatin, Lipitor®': PBMCwere collected for immune activation assays using flowcytometry
|
Placebo First, Then Atorvastatin
n=15 participants at risk
Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC wiere collected for immune activation assays using flowcytometry
Placebo: PBMC were collected for immune activation assays using flowcytometry
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
3/15 • Number of events 3 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
20.0%
3/15 • Number of events 3 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
20.0%
3/15 • Number of events 3 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
6.7%
1/15 • Number of events 1 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
|
General disorders
headache
|
6.7%
1/15 • Number of events 1 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
20.0%
3/15 • Number of events 3 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
|
Musculoskeletal and connective tissue disorders
Joint pains
|
13.3%
2/15 • Number of events 2 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
6.7%
1/15 • Number of events 1 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
|
Musculoskeletal and connective tissue disorders
backache
|
6.7%
1/15 • Number of events 1 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
0.00%
0/15 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
|
General disorders
Abdominal pain
|
0.00%
0/15 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
6.7%
1/15 • Number of events 1 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
0.00%
0/15 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
|
Musculoskeletal and connective tissue disorders
right forearm pain
|
6.7%
1/15 • Number of events 1 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
0.00%
0/15 • 12 weeks on study drug, 4 weeks wash out, then 12 weeks of placebo
No serious adverse event reported
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place