Telmisartan to Reduce AIDS-Related Fibrotic and Inflammat... | NCT01928927

ID	Type	Description	Link
UM1AI068636	U.S. NIH Grant/Contract		View source

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Description Module

Label	Type	Description	Intervention Names
Arm A: Telmisartan	Experimental		Drug: Telmisartan
Arm B: No Study Drug	No Intervention	Participants received no study drug and followed the week 0-48 evaluation schedule.

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan	Drug	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.	Arm A: Telmisartan

Measure	Description	Time Frame
Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48	Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.	baseline and week 48
Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48	Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.	baseline and week 48

Measure	Description	Time Frame
Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48	Absolute change was calculated as the value at week 48 minus the value at baseline.	baseline and week 48
Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

Eligibility Module

Eligibility Criteria

Step 1 Inclusion Criteria:

HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to Step 1 entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV-1 RNA viral load >2000 copies/mL on two occasions.
On antiretroviral therapy (ART) continuously for ≥48 weeks prior to Step 1 entry.
Documentation of HIV-1 RNA <50 copies/mL at screening, performed by any US laboratory that has a CLIA certification or its equivalent.
At least one HIV-1 RNA level <200 copies/mL in the 48 weeks prior to Step 1 entry (not including the screening).
No change in ART regimen in the 12 weeks prior to Step 1 entry (except as noted below).

NOTE: Modifications of ART dosing during the 12 weeks prior to Step 1 entry are permitted. In addition, the change in formulation (eg, from standard formulation to fixed dose combination or single tablet regimen) is allowed within 12 weeks of Step 1 entry. A within-class single drug substitution (eg, switch from nevirapine to efavirenz or from atazanavir to darunavir) is allowed within 12 weeks of Step 1 entry, with the exception of a switch from any other NRTI to abacavir. No other changes in ART in the 12 weeks prior to Step 1 entry are permitted.

No active plan to change ART for the 48-week study duration.
Body mass index (BMI) 20-35 kg/m^2.
For females of reproductive potential, negative serum or urine pregnancy test within 3 days prior to Step 1 entry.
Ability and willingness of subject or legal guardian/representative to provide informed consent.
Willingness to undergo the Step 1 entry and week 48 lymphoid and adipose tissue biopsies.

Step 2 Inclusion Criteria:

Entry lymphoid tissue and adipose tissue specimen for assay of the primary endpoint has been obtained. (Prior to Letter of Amendment #2, 11/19/14)
(Letter of Amendment #2, 11/19/14) Entry lymphoid tissue and adipose tissue specimens for assay of the primary endpoint have been obtained, entered into the ACTG's Laboratory Data Management System (LDMS), and confirmed by the protocol team as adequate for endpoint determination.

NOTE: If the lymph node specimen is determined by the protocol team to be inadequate for endpoint determination despite the interventions summarized in LOA #2, the participant will be permitted to enroll if adequate adipose tissue is obtained. However, as change in lymph node fibrosis remains one of the primary endpoints of this study, it is critical that every effort be made to obtain an adequate sample while still trying to minimize complication rates.

Willingness to undergo the week 48 lymphoid and adipose tissue biopsies. (Prior to Letter of Amendment #2, 11/19/14)
(Letter of Amendment #2, 11/19/14) Willingness to undergo the week 48 lymphoid and adipose tissue biopsies.

NOTE: A week 48 lymph node biopsy is not required if the Step 1 lymph node specimen was deemed inadequate as noted in 4.3.1. Week 48 adipose tissue biopsies will still be required for these participants.

Step 1 Exclusion Criteria:

More than one HIV-1 RNA >200 copies/mL in the 48 weeks prior to Step 1 entry.
One HIV-1 RNA 200-500 copies/mL in the 24 weeks prior to Step 1 entry that is not immediately preceded and followed by HIV-1 RNA <50 copies/mL.

NOTE: The preceding viral load <50 copies/mL may be >24 weeks prior to Step 1 entry.

Confirmed systolic blood pressure >160 mmHg or <100 mmHg or diastolic blood pressure >100 mmHg.
Known untreated renal artery stenosis.
Known cirrhosis or severe liver disease (eg, ascites, encephalopathy, history of variceal bleeding).

NOTE: Potential subjects with chronic hepatitis B or C virus infection with no known cirrhosis or severe liver disease may participate in the study, provided there are no plans to start therapy for hepatitis C infection during the 48-week study duration.

Unstable coronary artery disease/angina or decompensated congestive heart failure.
Either breastfeeding or pregnant within 24 weeks prior to Step 1 entry.
Use of thiazolidinediones or any angiotensin receptor blocker (ARB) or angiotensin converting enzyme inhibitor (ACEi) in the 24 weeks prior to Step 1 entry. If the subject took either of these classes of medications for less than 2 weeks in the 24 weeks prior to Step 1 entry, the subject may enroll if 30 days have passed since the last dose. If the subject is diabetic and/or has a calculated glomerular filtration rate (GFR) <60mL/min, aliskiren-containing medications are also prohibited.
History of intolerance, other than cough, to any ARB or ACEi.
Use of anticoagulants other than aspirin 81 mg or 325 mg daily. NOTE: If the subject is on aspirin 81 mg or 325 mg daily and is willing/able to stop therapy for 7 days prior to the biopsy procedures, the subject may enroll.
Any known bleeding disorder or coagulopathy.
Projected need for daily potassium supplementation for ≥2 weeks during the study period.
The following laboratory values obtained within 30 days prior to Step 1 entry by any US laboratory that has a CLIA certification or its equivalent:
- Absolute neutrophil count (ANC) ≤750 cells/mm^3
- Hemoglobin ≤10 g/dL
- Platelet count ≤75,000/mm^3
- Calculated creatinine clearance (CrCl) <50 mL/min, as estimated by the Cockcroft-Gault equation
- Aspartate aminotransferase (AST) (SGOT) >/=3x ULN (upper limit of normal)
- Alanine aminotransferase (ALT) (SGPT) >/=3x ULN
- Partial thromboplastin time (PTT) >1.2x ULN
- Prothrombin time (PT) >1.2x ULN
Heritable connective tissue disorders (eg Ehlers-Danlos syndrome, osteogenesis imperfecta, Stickler syndrome, Marfan's syndrome).

NOTE: Subjects with acquired/autoimmune chronic inflammatory diseases/connective tissue disorders who are clinically stable (in the opinion of the site investigator) and not on a prohibited medication may enroll with approval of the A5317 study chairs.

Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to Step 1 entry.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.

Step 2 Exclusion Criteria:

- Any AE associated with the Step 1 entry biopsy that would exclude the subject from undergoing follow-up biopsy at week 48.

Name	Affiliation	Role
Jordan E. Lake, MD, MSc	The University of Texas Health Science Center, Houston	Study Chair
Netanya Sandler, MD	The University of Texas Medical Branch, Galveston	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
UCLA CARE Center CRS (601)		Los Angeles	California	90035	United States
University of Colorado Hospital CRS (6101)

Label	URL
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)	View source

ID	Type	URL	Comment
	Grading table	View IPD

ID	Title	Description
FG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
FG001	Arm B: No Study Drug

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	OG000-2.44(-10.60 to 3.77) OG001-6.08(-11.66 to 5.84)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis: theta = 0.50	Theta statistic; DeLong & Clarke-Pearson		0.97	No adjustment for multiple comparisons	Theta statistic	0.50			2-Sided	95	0.26	0.73			The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is <= a randomly selected outcome from the control arm.		Superiority

Primary

Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.

Additionally, have non-missing subcutaneous abdominal adipose tissue collagen I deposition.

Posted

Median

Inter-Quartile Range

percent area stain positive

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants

Secondary

Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing lymphoid tissue fibronectin deposition.

Posted

Median

Inter-Quartile Range

percent area stain positive

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing adipose tissue fibronectin deposition.

Posted

Median

Inter-Quartile Range

percent area stain positive

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and followed the week 0-48 evaluation schedule.

Units	Counts
Participants	OG000

Secondary

Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing adipose collagen VI deposition.

Posted

Median

Inter-Quartile Range

percent area stain positive

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Highest Grade Non-biopsy-related Adverse Event

Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant.

Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table.

NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol.

All Step 2 participants

Posted

Count of Participants

Participants

after baseline to week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants

Secondary

Change in IL-6 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing IL-6.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in IL-6 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing IL-6.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in IL-6 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing IL-6.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in IL-7 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing IL-7.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in IL-7 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing IL-7.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in IL-7 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing IL-7.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Adiponectin From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing adiponectin.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Adiponectin From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing adiponectin.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Adiponectin From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing adiponectin.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing CICP.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing CICP.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CICP.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Hyaluronic Acid From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing hyaluronic acid.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Hyaluronic Acid From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing hyaluronic acid.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Hyaluronic Acid From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing hyaluronic acid.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in sCD14 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing sCD14.

Posted

Median

Inter-Quartile Range

mcg/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in sCD14 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing sCD14.

Posted

Median

Inter-Quartile Range

mcg/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in sCD14 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing sCD14.

Posted

Median

Inter-Quartile Range

mcg/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in sCD163 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing sCD163.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in sCD163 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing sCD163.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in sCD163 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing sCD163.

Posted

Median

Inter-Quartile Range

ng/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β1 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing TGF-β1.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β1 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing TGF-β1.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β1 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing TGF-β1.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β2 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing TGF-β2.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β2 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing TGF-β2.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β2 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing TGF-β2.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β3 From Baseline to Week 4

Absolute change was calculated as the value at week 4 minus the value at baseline.

Additionally, have non-missing TGF-β3.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 4

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β3 From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing TGF-β3.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in TGF-β3 From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing TGF-β3.

Posted

Median

Inter-Quartile Range

pg/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Circulating CD4+ T Cell Count From Baseline to Week 12

Absolute change was calculated as the value at week 12 minus the value at baseline.

Additionally, have non-missing CD4+ count.

Posted

Median

Inter-Quartile Range

cells/mm^3

baseline and week 12

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Circulating CD4+ T Cell Count From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing CD4+ count.

Posted

Median

Inter-Quartile Range

cells/mm^3

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Circulating CD4+ T Cell Count From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD4+ count.

Posted

Median

Inter-Quartile Range

cells/mm^3

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Circulating CD8+ T Cell Count From Baseline to Week 12

Absolute change was calculated as the value at week 12 minus the value at baseline.

Additionally, have non-missing CD8+ count.

Posted

Median

Inter-Quartile Range

cells/mm^3

baseline and week 12

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Circulating CD8+ T Cell Count From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing CD8+ count.

Posted

Median

Inter-Quartile Range

cells/mm^3

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Circulating CD8+ T Cell Count From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD8+ count.

Posted

Median

Inter-Quartile Range

cells/mm^3

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Fasting Glucose From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing fasting glucose.

Posted

Median

Inter-Quartile Range

mg/dl

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Fasting HDL Cholesterol From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing fasting HDL cholesterol.

Posted

Median

Inter-Quartile Range

mg/dl

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Fasting Insulin From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing fasting insulin.

Posted

Median

Inter-Quartile Range

uIU/ml

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Fasting LDL Cholesterol From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing fasting LDL cholesterol.

Posted

Median

Inter-Quartile Range

mg/dl

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Fasting Total Cholesterol From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing fasting total cholesterol.

Posted

Median

Inter-Quartile Range

mg/dl

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Fasting Triglycerides From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing fasting triglycerides.

Posted

Median

Inter-Quartile Range

mg/dl

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in HOMA-IR From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing HOMA-IR.

Posted

Median

Inter-Quartile Range

(mg/dl)x(uIU/ml)/405

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Prevalence of Metabolic Syndrome at Week 24.

Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40" (101.6 cm) in men, >35" (88.9 cm) in women with the exception of Asian-Americans: >35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.

NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis.

Additionally, have non-missing metabolic syndrome components.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Secondary

Presence of Metabolic Syndrome at Week 48.

Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40" (101.6 cm) in men, >35" (88.9 cm) in women with the exception of Asian-Americans: >35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.

Additionally, have non-missing metabolic syndrome components.

Posted

Count of Participants

Participants

Week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Secondary

Change in Waist Circumference From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing waist circumference.

Posted

Median

Inter-Quartile Range

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Waist Circumference From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing waist circumference.

Posted

Median

Inter-Quartile Range

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Waist-to-hip Ratio From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing waist-to-hip ratio.

Posted

Median

Inter-Quartile Range

waist cm : hip cm

baseline and week 24

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Waist-to-hip Ratio From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing waist-to-hip ratio.

Posted

Median

Inter-Quartile Range

waist cm : hip cm

baseline and week 48

ID	Title	Description
OG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing CD4+CD38+HLA-DR+ data.

Posted

Median

Inter-Quartile Range

Percent of CD4+ expressing CD38+HLA-DR+

24 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24

Absolute change was calculated as the value at week 24 minus the value at baseline.

Additionally, have non-missing CD8+CD38+HLA-DR+ data.

Posted

Median

Inter-Quartile Range

Percent of CD8+ expressing CD38+HLA-DR+

24 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD4+CD38+HLA-DR+ data.

Posted

Median

Inter-Quartile Range

Percent of CD4+ expressing CD38+HLA-DR+

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD8+CD38+HLA-DR+ data.

Posted

Median

Inter-Quartile Range

Percent of CD8+ expressing CD38+HLA-DR+

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD163+ adipose tissue data.

Posted

Median

Inter-Quartile Range

Percent of CD163+ adipose tissue cells

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD4+ lymphoid tissue data.

Posted

Median

Inter-Quartile Range

Percent of CD4+ lymphoid tissue cells

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD8+ lymphoid tissue data.

Posted

Median

Inter-Quartile Range

Percent of CD8+ lymphoid tissue cells

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD163+ lymphoid tissue data.

Posted

Median

Inter-Quartile Range

Percent of CD163+ lymphoid tissue cells

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD68+ lymphoid tissue data.

Posted

Median

Inter-Quartile Range

Percent of CD68+ lymphoid tissue cells

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD38+HLA-DR+ on CD4+ lymphoid tissue data.

Posted

Median

Inter-Quartile Range

Percent of CD38+HLA-DR+ on CD4+ cells

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Secondary

Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.

Absolute change was calculated as the value at week 48 minus the value at baseline.

Additionally, have non-missing CD38+HLA-DR+ on CD8+ lymphoid tissue data.

Posted

Median

Inter-Quartile Range

Percent of CD38+HLA-DR+ on CD8+ cells

48 weeks

ID	Title	Description
OG000	Arm A: Telmisartan	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
OG001	Arm B: No Study Drug	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eye pruritus	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected15 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Anorectal swelling	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected15 at risk
Perianal erythema	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Rectal discharge	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected15 at risk
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Chills	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Peripheral swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected15 at risk
Seasonal allergy	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Perirectal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0004 affected29 at risk EG0011 affected15 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0004 affected29 at risk EG0013 affected15 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Blood bilirubin increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0004 affected29 at risk EG0012 affected15 at risk
Blood cholesterol increased	Investigations	MedDRA 19.1	Systematic Assessment	EG00013 affected29 at risk EG0014 affected15 at risk
Blood creatinine increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected15 at risk
Blood glucose increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0004 affected29 at risk EG0011 affected15 at risk
Blood magnesium decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected15 at risk
Blood phosphorus decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0007 affected29 at risk EG0013 affected15 at risk
Blood sodium decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0007 affected29 at risk EG0012 affected15 at risk
Low density lipoprotein increased	Investigations	MedDRA 19.1	Systematic Assessment	EG00013 affected29 at risk EG0014 affected15 at risk
Neutrophil count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Platelet count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Weight decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected15 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Anxiety	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Sleep disorder	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Dysuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Penile discharge	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Penile pain	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected29 at risk EG0011 affected15 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected15 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected15 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected15 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan
BG001	Arm B: No Study Drug	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	0	29	3	29	24	29
EG001	Arm B: No Study Drug	Participants received no study drug and will follow week 0-48 evaluation schedule. Control	0	15	1	15	10	15

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected15 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected15 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected15 at risk
Hepatic enzyme increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected15 at risk