Trial Outcomes & Findings for Modulation of Monocyte Activation by Atorvastatin in HIV Infection (NCT NCT01263938)
NCT ID: NCT01263938
Last Updated: 2019-05-01
Results Overview
Effects of Atorvastatin on immune activation associated surface markers (CD16, CD163 and CCR2) of monocytes were assessed in chronic HIV+/HAART+ subjects following 12 weeks of treatment. Whole blood drawn from these subjects were stained with fluorochrome tagged antibodies to the surface markers. Stained whole blood cells were then acquired on a flow cytometer and analyzed using the Flowjo software to determine the percentage of cells (monocytes) expressing the specific marker. This was done before starting and after completing drug treatment to assess the effect of drug.
COMPLETED
PHASE4
5 participants
Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)
2019-05-01
Participant Flow
Subjects were recruited from the AIDS Clinical Trial Unit (ACTU) at the Hospital of University Of Pennsylvania, Philadelphia, PA. The screening and recruitment process was carried out during the period September 2011 thru April 2012.
Enrolled participants were assigned to treatment groups based on the nature of HAART therapy (PI- or non-PI based).
Participant milestones
| Measure |
Atorvastatin
Atorvastatin: For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.
For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modulation of Monocyte Activation by Atorvastatin in HIV Infection
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=5 Participants
Atorvastatin: For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.
For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)Population: 1\) Percentage of peripheral blood monocyte surface markers: CD16, CD163, CCR2
Effects of Atorvastatin on immune activation associated surface markers (CD16, CD163 and CCR2) of monocytes were assessed in chronic HIV+/HAART+ subjects following 12 weeks of treatment. Whole blood drawn from these subjects were stained with fluorochrome tagged antibodies to the surface markers. Stained whole blood cells were then acquired on a flow cytometer and analyzed using the Flowjo software to determine the percentage of cells (monocytes) expressing the specific marker. This was done before starting and after completing drug treatment to assess the effect of drug.
Outcome measures
| Measure |
Atorvastatin
n=5 Participants
For subjects on PI-based HAART:
10mg/day X 2weeks followed by 20mg/day.
For subjects on non PI-based HAART:
20mg/day X 2weeks followed by 40mg/day.
For all subjects treatment was stopped at 12 weeks.
|
|---|---|
|
Change in Monocyte Surface Markers Expression (Expressed as Percentage), Following Treatment of Chronic HIV+/ HAART+ Subjects With Atorvastatin (T=12wks Versus T=0wk).
Total CD14+CD16+ monocytes
|
1.5 Change T=0 to T=12 (percentage change)
Standard Deviation 10.2
|
|
Change in Monocyte Surface Markers Expression (Expressed as Percentage), Following Treatment of Chronic HIV+/ HAART+ Subjects With Atorvastatin (T=12wks Versus T=0wk).
CD14+CD163+ monocytes
|
-4.4 Change T=0 to T=12 (percentage change)
Standard Deviation 18
|
|
Change in Monocyte Surface Markers Expression (Expressed as Percentage), Following Treatment of Chronic HIV+/ HAART+ Subjects With Atorvastatin (T=12wks Versus T=0wk).
CD14+CCR2+ monocytes
|
0.5 Change T=0 to T=12 (percentage change)
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)Population: Plasma MCP-1 levels
Monocyte specific inflammatory soluble factor MCP-1 was measured by ELISA in plasma of HIV+/HAART+ subjects at baseline and at 12 weeks following atorvastatin treatment.
Outcome measures
| Measure |
Atorvastatin
n=5 Participants
For subjects on PI-based HAART:
10mg/day X 2weeks followed by 20mg/day.
For subjects on non PI-based HAART:
20mg/day X 2weeks followed by 40mg/day.
For all subjects treatment was stopped at 12 weeks.
|
|---|---|
|
Change From Baseline in Levels of Plasma Inflammatory Marker MCP-1 of Chronic HIV+/ HAART+ Subjects.
|
10 pg/ml (Change from T0 to T12)
Standard Deviation 176.5
|
PRIMARY outcome
Timeframe: Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)Population: Plasma sCD14 levels
Monocyte specific inflammatory soluble factor sCD14 was measured by ELISA in plasma of HIV+/HAART+ subjects at baseline and at 12 weeks following atorvastatin treatment.
Outcome measures
| Measure |
Atorvastatin
n=5 Participants
For subjects on PI-based HAART:
10mg/day X 2weeks followed by 20mg/day.
For subjects on non PI-based HAART:
20mg/day X 2weeks followed by 40mg/day.
For all subjects treatment was stopped at 12 weeks.
|
|---|---|
|
Change From Baseline in Levels of Plasma Inflammatory Marker sCD14 of Chronic HIV+/ HAART+ Subjects.
|
-0.22 ug/ml (Change fromT=0 to T=12wk)
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Subjects enrolled in the study following the screening visit were assessed for the primary outcome measures at T=0 (drug intervention begins); T=12wks (intervention ends)Population: Plasma sCD163 levels
Monocyte specific inflammatory soluble factor sCD163 was measured by ELISA in plasma of HIV+/HAART+ subjects at baseline and at 12 weeks following atorvastatin treatment.
Outcome measures
| Measure |
Atorvastatin
n=5 Participants
For subjects on PI-based HAART:
10mg/day X 2weeks followed by 20mg/day.
For subjects on non PI-based HAART:
20mg/day X 2weeks followed by 40mg/day.
For all subjects treatment was stopped at 12 weeks.
|
|---|---|
|
Change From Baseline in Levels of Plasma Inflammatory Marker sCD163 of Chronic HIV+/ HAART+ Subjects.
|
-18 ng/ml (Change fromT=0 to T=12wk)
Standard Deviation 81
|
Adverse Events
Atorvastatin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ronald Collman
University of Pennsylvania School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place