Trial · NCT00965185

Statin Therapy to Improve Atherosclerosis in HIV Patients

NCT00965185, Not applicable, Completed, Massachusetts General Hospital; results first posted 2015-02-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Statin Therapy to Improve Atherosclerosis in HIV Patients. Trials, record NCT00965185. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00965185

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Statin Therapy to Improve Atherosclerosis in HIV Patients
NCT number: NCT00965185
Status: Completed
Phases: Not applicable
Enrollment: 40 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Cardiovascular Disease, HIV, Atherosclerosis, Inflammation, Statins, HMG-CoA, HIV Infections
Interventions: atorvastatin, Placebo
First posted: 2009-08-25
Last updated: 2017-12-11
Results first posted: 2015-02-26
Limitations and caveats: FDG-PET scan data was interpretable in only a limited subset of participants as a result of technical problems with manual co-registration (outcome 1). We were unable to collect data for endothelial function due to equipment malfunction (outcome 3).

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Coronary and Aortic Plaque Inflammation	Measured at baseline and 1 year	12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)
Secondary	Plaque Progression	Measured at baseline and 1 year	12 month percent change in plaque volume
Secondary	Endothelial Function	1 year	Assessment of endothelial function was to be measured by endothelial vasodilator function.
Secondary	Immune Function	Measured at baseline and 1 year	12 month change in CD4 T-lymphocytes
Secondary	Lipid Profile	Measured at baseline and 1 year	12 month change in lipid profile
Secondary	C-reactive Protein (CRP)	Measured at baseline and 1 year	12 month change in Log CRP concentration
Secondary	Adipocytokines	Measured at baseline and 1 year	12 month change in IL-6
Secondary	Liver Function Tests (LFTs)	Measured at baseline, 1, 3, 6, 9, and 12 months	Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal). For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed. ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Coronary and Aortic Plaque Inflammation	Measured at baseline and 1 year	All participants with baseline and 12 month PET and CT scans of acceptable image quality to permit assessment of change over time in identical regions in serial scans. As a result, only a limited number of participants could be included.	ratio	MEAN
SECONDARY	Plaque Progression	Measured at baseline and 1 year	All available data were used.	Percent change	MEAN
SECONDARY	Endothelial Function	1 year	Please note that we were unable to collect data for this outcome measure, entitled Endothelial Function due to equipment malfunction.
SECONDARY	Immune Function	Measured at baseline and 1 year	All available data were used; data were not available for one subject who completed the study.	cells per microliter	MEAN
SECONDARY	Lipid Profile	Measured at baseline and 1 year	All available data were used.	mmol/L	MEAN
SECONDARY	C-reactive Protein (CRP)	Measured at baseline and 1 year	All available data were used.	log(mg/L)	MEAN
SECONDARY	Adipocytokines	Measured at baseline and 1 year		pg/ml	MEAN
SECONDARY	Liver Function Tests (LFTs)	Measured at baseline, 1, 3, 6, 9, and 12 months	All available data were used.	participants	NUMBER

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Coronary and Aortic Plaque Inflammation	Atorvastatin	Mean FDG-PET TBR of aorta	0.04	95% Confidence Interval -0.08 to 0.16	ratio
Coronary and Aortic Plaque Inflammation	Placebo	Mean FDG-PET TBR of aorta	-0.05	95% Confidence Interval -0.28 to 0.17	ratio
Coronary and Aortic Plaque Inflammation	Atorvastatin	Mean FDG-PET TBR of most diseased segment of aorta	-0.03	95% Confidence Interval -0.17 to 0.12	ratio
Coronary and Aortic Plaque Inflammation	Placebo	Mean FDG-PET TBR of most diseased segment of aorta	-0.06	95% Confidence Interval -0.25 to 0.13	ratio
Plaque Progression	Atorvastatin	12 month change in total plaque volume	-4.7	95% Confidence Interval -25.4 to 15.9	Percent change
Plaque Progression	Placebo	12 month change in total plaque volume	18.2	95% Confidence Interval 1.5 to 59.9	Percent change
Plaque Progression	Atorvastatin	12 month change in non-calcified plaque volume	-19.4	95% Confidence Interval -39.2 to 9.3	Percent change
Plaque Progression	Placebo	12 month change in non-calcified plaque volume	20.4	95% Confidence Interval -7.1 to 94.4	Percent change
Immune Function	Atorvastatin		17	95% Confidence Interval -68 to 101	cells per microliter
Immune Function	Placebo		4	95% Confidence Interval -72 to 80	cells per microliter

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Atorvastatin	19
Overall Study	STARTED	Placebo	21
Overall Study	1 Month Visit	Atorvastatin	18
Overall Study	1 Month Visit	Placebo	21
Overall Study	3 Month Visit	Atorvastatin	18
Overall Study	3 Month Visit	Placebo	21
Overall Study	6 Month Visit	Atorvastatin	18
Overall Study	6 Month Visit	Placebo	21
Overall Study	9 Month Visit	Atorvastatin	18
Overall Study	9 Month Visit	Placebo	21

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Loose stools	Gastrointestinal disorders	Atorvastatin	3	19
other	Loose stools	Gastrointestinal disorders	Placebo	1	21
other	Nausea	Gastrointestinal disorders	Atorvastatin	1	19
other	Nausea	Gastrointestinal disorders	Placebo	2	21
other	Muscle aches or cramps	Musculoskeletal and connective tissue disorders	Atorvastatin	6	19
other	Muscle aches or cramps	Musculoskeletal and connective tissue disorders	Placebo	5	21
other	Liver function test abnormalities	Hepatobiliary disorders	Atorvastatin	3	19
other	Liver function test abnormalities	Hepatobiliary disorders	Placebo	2	21
other	Elevated fasting blood glucose	Metabolism and nutrition disorders	Atorvastatin	0	19
other	Elevated fasting blood glucose	Metabolism and nutrition disorders	Placebo	2	21

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atorvastatin
Total, all-cause mortality	Placebo
Total, other adverse events	Atorvastatin	13	19
Total, other adverse events	Placebo	14	21
Total, serious adverse events	Atorvastatin	2	19
Total, serious adverse events	Placebo	1	21

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22820791	BACKGROUND	PubMed
26424461	RESULT	PubMed
29419569	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL095123	Inflammatory Mechanisms and Treatment Strategies for Atherosclerosis in HIV	GRINSPOON, STEVEN K.	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2009 to 2013

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Atorvastatin vs Placebo: Liver Function Tests (LFTs)	Trial comparisons
Atorvastatin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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