Trial Outcomes & Findings for Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study) (NCT NCT01928927)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

baseline and week 48

Results posted on

2021-08-03

Participant Flow

58 participants enrolled to Step 1 between January 6, 2014 and April 13, 2015. Step 1 was a run-in period to ensure successful pre-randomization biopsies were obtained. 44 participants did have successful Step 1 biopsy and were randomized to Step 2 between January 13, 2014 and April 22, 2015.

All participants enrolled to Step 1. Participants with successful Step 1 biopsies and eligible for Step 2 were randomized to the two study arms using a 2:1 allocation ratio with permuted blocks of size 3 and without institutional balancing. There was no stratification.

Participant milestones

Participant milestones
Measure	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	Arm B: No Study Drug Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Overall Study STARTED	29	15
Overall Study COMPLETED	27	14
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Arm B: No Study Drug Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Participants with non-missing waist circumference data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Telmisartan n=29 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=15 Participants Participants received no study drug and were followed week 0-48 evaluation schedule. Control	Total n=44 Participants Total of all reporting groups
Age, Continuous	47 years n=29 Participants	50 years n=15 Participants	48 years n=44 Participants
Age, Customized 18-29 years	0 Participants n=29 Participants	2 Participants n=15 Participants	2 Participants n=44 Participants
Age, Customized 30-39 years	6 Participants n=29 Participants	2 Participants n=15 Participants	8 Participants n=44 Participants
Age, Customized 40-49 years	12 Participants n=29 Participants	3 Participants n=15 Participants	15 Participants n=44 Participants
Age, Customized 50-59 years	11 Participants n=29 Participants	6 Participants n=15 Participants	17 Participants n=44 Participants
Age, Customized 60-69 years	0 Participants n=29 Participants	2 Participants n=15 Participants	2 Participants n=44 Participants
Sex: Female, Male Female	2 Participants n=29 Participants	1 Participants n=15 Participants	3 Participants n=44 Participants
Sex: Female, Male Male	27 Participants n=29 Participants	14 Participants n=15 Participants	41 Participants n=44 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=29 Participants	1 Participants n=15 Participants	8 Participants n=44 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=29 Participants	14 Participants n=15 Participants	36 Participants n=44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants	0 Participants n=15 Participants	0 Participants n=44 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=29 Participants	0 Participants n=15 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Asian	0 Participants n=29 Participants	0 Participants n=15 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants	0 Participants n=15 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Black or African American	6 Participants n=29 Participants	8 Participants n=15 Participants	14 Participants n=44 Participants
Race (NIH/OMB) White	22 Participants n=29 Participants	7 Participants n=15 Participants	29 Participants n=44 Participants
Race (NIH/OMB) More than one race	1 Participants n=29 Participants	0 Participants n=15 Participants	1 Participants n=44 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants	0 Participants n=15 Participants	0 Participants n=44 Participants
Race/Ethnicity, Customized White Non-Hispanic	16 Participants n=29 Participants	6 Participants n=15 Participants	22 Participants n=44 Participants
Race/Ethnicity, Customized Black Non-Hispanic	5 Participants n=29 Participants	8 Participants n=15 Participants	13 Participants n=44 Participants
Race/Ethnicity, Customized Hispanic (Regardless of Race)	7 Participants n=29 Participants	1 Participants n=15 Participants	8 Participants n=44 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=29 Participants	0 Participants n=15 Participants	1 Participants n=44 Participants
IV drug history No History	25 Participants n=29 Participants	13 Participants n=15 Participants	38 Participants n=44 Participants
IV drug history Previous History	4 Participants n=29 Participants	2 Participants n=15 Participants	6 Participants n=44 Participants
BMI	25.4 kg/m^2 n=29 Participants	23.7 kg/m^2 n=15 Participants	25.0 kg/m^2 n=44 Participants
Waist circumference	92 cm n=28 Participants • Participants with non-missing waist circumference data.	86 cm n=14 Participants • Participants with non-missing waist circumference data.	88 cm n=42 Participants • Participants with non-missing waist circumference data.
Waist-to-hip ratio	0.94 ratio n=28 Participants • Participants with non-missing waist circumference data.	0.91 ratio n=14 Participants • Participants with non-missing waist circumference data.	0.93 ratio n=42 Participants • Participants with non-missing waist circumference data.
CD4+	604 cells/mm^3 n=28 Participants • Participants with non-missing CD4+ data.	556 cells/mm^3 n=15 Participants • Participants with non-missing CD4+ data.	588 cells/mm^3 n=43 Participants • Participants with non-missing CD4+ data.
HIV-1 RNA <40 copies/ml	24 Participants n=29 Participants	11 Participants n=15 Participants	35 Participants n=44 Participants
HIV-1 RNA 40 - <200 copies/ml	3 Participants n=29 Participants	3 Participants n=15 Participants	6 Participants n=44 Participants
HIV-1 RNA >= 200 copies/ml	2 Participants n=29 Participants	1 Participants n=15 Participants	3 Participants n=44 Participants
Lymphoid Tissue Collagen I Deposition	15.3 percent area stain positive n=24 Participants • Participants with non-missing lymphoid tissue collagen I deposition data.	12.6 percent area stain positive n=15 Participants • Participants with non-missing lymphoid tissue collagen I deposition data.	13.9 percent area stain positive n=39 Participants • Participants with non-missing lymphoid tissue collagen I deposition data.
Adipose Tissue Collagen I Deposition	1.51 percent area stain positive n=29 Participants	2.83 percent area stain positive n=15 Participants	2.11 percent area stain positive n=44 Participants

PRIMARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing lymphoid tissue collagen I deposition.

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.

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=17 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48	-2.44 percent area stain positive Interval -10.6 to 3.77	-6.08 percent area stain positive Interval -11.66 to 5.84

PRIMARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing subcutaneous abdominal adipose tissue collagen I deposition.

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.

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=16 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=9 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48	-1.43 percent area stain positive Interval -10.61 to 4.17	0.36 percent area stain positive Interval -6.57 to 6.41

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing lymphoid tissue fibronectin deposition.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=19 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=11 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48	0.01 percent area stain positive Interval -0.4 to 0.35	0.61 percent area stain positive Interval -0.09 to 1.4

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing adipose tissue fibronectin deposition.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48	-0.82 percent area stain positive Interval -4.0 to 0.45	-4.01 percent area stain positive Interval -6.02 to -1.63

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing adipose collagen VI deposition.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48	-0.41 percent area stain positive Interval -4.03 to 0.31	-1.36 percent area stain positive Interval -2.04 to -0.67

SECONDARY outcome

Timeframe: after baseline to week 48

Population: All Step 2 participants

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.

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=29 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=15 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Highest Grade Non-biopsy-related Adverse Event Grade 0	12 Participants	6 Participants
Highest Grade Non-biopsy-related Adverse Event Grade 1	0 Participants	0 Participants
Highest Grade Non-biopsy-related Adverse Event Grade 2	11 Participants	3 Participants
Highest Grade Non-biopsy-related Adverse Event Grade 3	5 Participants	5 Participants
Highest Grade Non-biopsy-related Adverse Event Grade 4	1 Participants	1 Participants

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing IL-6.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in IL-6 From Baseline to Week 4	-0.50 pg/ml Interval -0.8 to 0.11	-0.01 pg/ml Interval -0.29 to 0.27

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing IL-6.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in IL-6 From Baseline to Week 24	-0.53 pg/ml Interval -0.69 to 0.04	0.04 pg/ml Interval -0.48 to 0.85

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing IL-6.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in IL-6 From Baseline to Week 48	-0.46 pg/ml Interval -0.86 to 0.13	-0.03 pg/ml Interval -0.48 to 1.18

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing IL-7.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in IL-7 From Baseline to Week 4	0.48 pg/ml Interval -0.21 to 2.18	-0.32 pg/ml Interval -4.34 to 0.37

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing IL-7.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in IL-7 From Baseline to Week 24	0.51 pg/ml Interval -0.13 to 2.32	-1.36 pg/ml Interval -3.94 to 0.44

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing IL-7.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in IL-7 From Baseline to Week 48	0.06 pg/ml Interval -0.82 to 1.73	0.53 pg/ml Interval -1.18 to 2.28

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing adiponectin.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Adiponectin From Baseline to Week 4	177.20 ng/ml Interval -1624.5 to 1949.7	161.00 ng/ml Interval -528.3 to 1597.35

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing adiponectin.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Adiponectin From Baseline to Week 24	-582 ng/ml Interval -1709.3 to 714.2	1222.60 ng/ml Interval -867.6 to 3278.15

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing adiponectin.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Adiponectin From Baseline to Week 48	-138.70 ng/ml Interval -1935.2 to 1521.7	113.80 ng/ml Interval -3150.0 to 907.8

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CICP.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4	-2.14 ng/ml Interval -14.94 to 8.45	-9.10 ng/ml Interval -27.38 to 14.29

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CICP.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24	-13.78 ng/ml Interval -37.69 to 5.93	-1.17 ng/ml Interval -24.43 to 40.16

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CICP.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48	-10.76 ng/ml Interval -40.5 to 27.78	-6.10 ng/ml Interval -31.99 to 6.36

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing hyaluronic acid.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Hyaluronic Acid From Baseline to Week 4	-0.03 ng/ml Interval -8.46 to 16.63	3.14 ng/ml Interval -7.29 to 14.42

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing hyaluronic acid.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Hyaluronic Acid From Baseline to Week 24	-1.62 ng/ml Interval -18.32 to 1.19	3.71 ng/ml Interval -5.83 to 30.2

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing hyaluronic acid.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Hyaluronic Acid From Baseline to Week 48	-2.74 ng/ml Interval -18.52 to 9.84	-1.79 ng/ml Interval -6.96 to 14.49

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing sCD14.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in sCD14 From Baseline to Week 4	-0.03 mcg/ml Interval -0.37 to 0.08	0.05 mcg/ml Interval -0.06 to 0.25

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing sCD14.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in sCD14 From Baseline to Week 24	0.06 mcg/ml Interval -0.19 to 0.26	-0.08 mcg/ml Interval -0.15 to 0.09

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing sCD14.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in sCD14 From Baseline to Week 48	-0.08 mcg/ml Interval -0.26 to 0.12	0 mcg/ml Interval -0.17 to 0.36

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing sCD163.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in sCD163 From Baseline to Week 4	34.08 ng/ml Interval -33.96 to 174.04	0.88 ng/ml Interval -45.16 to 106.08

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing sCD163.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in sCD163 From Baseline to Week 24	58.72 ng/ml Interval -44.52 to 206.52	9.58 ng/ml Interval -49.4 to 56.72

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing sCD163.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in sCD163 From Baseline to Week 48	31.14 ng/ml Interval -200.04 to 160.2	5.32 ng/ml Interval -117.8 to 96.84

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β1.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β1 From Baseline to Week 4	793.37 pg/ml Interval -2080.11 to 3877.98	-1074.87 pg/ml Interval -5328.36 to 603.32

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β1.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β1 From Baseline to Week 24	175.02 pg/ml Interval -1249.67 to 4478.09	678.43 pg/ml Interval -3983.91 to 2816.12

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β1.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β1 From Baseline to Week 48	-319.17 pg/ml Interval -3429.94 to 1203.98	-516.45 pg/ml Interval -2307.66 to 2090.85

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β2.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β2 From Baseline to Week 4	70.74 pg/ml Interval -135.73 to 147.97	-129.40 pg/ml Interval -272.8 to -5.13

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β2.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β2 From Baseline to Week 24	75.84 pg/ml Interval -39.61 to 134.71	-134.68 pg/ml Interval -345.89 to -8.64

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β2.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β2 From Baseline to Week 48	44.45 pg/ml Interval -201.77 to 164.44	-55.94 pg/ml Interval -201.52 to 119.6

SECONDARY outcome

Timeframe: baseline and week 4

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β3.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β3 From Baseline to Week 4	31.26 pg/ml Interval -39.82 to 254.89	-95.17 pg/ml Interval -450.42 to -10.83

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β3.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β3 From Baseline to Week 24	34.64 pg/ml Interval -16.14 to 226.95	-68.01 pg/ml Interval -341.55 to 101.57

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing TGF-β3.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in TGF-β3 From Baseline to Week 48	-0.47 pg/ml Interval -176.53 to 175.68	-55.21 pg/ml Interval -163.05 to 135.04

SECONDARY outcome

Timeframe: baseline and week 12

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD4+ count.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=10 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Circulating CD4+ T Cell Count From Baseline to Week 12	-17.50 cells/mm^3 Interval -133.0 to 26.0	59.50 cells/mm^3 Interval -24.0 to 108.0

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD4+ count.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Circulating CD4+ T Cell Count From Baseline to Week 24	13 cells/mm^3 Interval -55.0 to 95.0	61.5 cells/mm^3 Interval -16.5 to 186.5

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD4+ count.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Circulating CD4+ T Cell Count From Baseline to Week 48	9 cells/mm^3 Interval -24.0 to 45.0	97 cells/mm^3 Interval 4.0 to 111.0

SECONDARY outcome

Timeframe: baseline and week 12

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD8+ count.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=10 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Circulating CD8+ T Cell Count From Baseline to Week 12	-33.5 cells/mm^3 Interval -130.0 to 111.5	83 cells/mm^3 Interval 30.0 to 154.0

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD8+ count.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Circulating CD8+ T Cell Count From Baseline to Week 24	-3.5 cells/mm^3 Interval -97.0 to 103.5	80.5 cells/mm^3 Interval -8.0 to 181.5

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD8+ count.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Circulating CD8+ T Cell Count From Baseline to Week 48	10 cells/mm^3 Interval -72.0 to 101.0	97 cells/mm^3 Interval -24.0 to 169.0

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing fasting glucose.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Fasting Glucose From Baseline to Week 48	4 mg/dl Interval -3.0 to 8.0	2 mg/dl Interval -5.0 to 12.0

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing fasting HDL cholesterol.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Fasting HDL Cholesterol From Baseline to Week 48	-1 mg/dl Interval -6.0 to 1.0	-4 mg/dl Interval -7.0 to 6.0

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing fasting insulin.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=22 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Fasting Insulin From Baseline to Week 48	3 uIU/ml Interval -1.0 to 4.0	0 uIU/ml Interval -2.0 to 8.0

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing fasting LDL cholesterol.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Fasting LDL Cholesterol From Baseline to Week 48	-12 mg/dl Interval -30.2 to 12.0	-7.4 mg/dl Interval -20.6 to 18.8

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing fasting total cholesterol.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Fasting Total Cholesterol From Baseline to Week 48	-8 mg/dl Interval -23.0 to 4.0	-2 mg/dl Interval -8.0 to 9.0

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing fasting triglycerides.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Fasting Triglycerides From Baseline to Week 48	7 mg/dl Interval -23.0 to 29.0	-16 mg/dl Interval -23.0 to 63.0

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing HOMA-IR.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in HOMA-IR From Baseline to Week 48	0.76 (mg/dl)x(uIU/ml)/405 Interval -0.02 to 1.01	-0.04 (mg/dl)x(uIU/ml)/405 Interval -0.42 to 1.03

SECONDARY outcome

Timeframe: Week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing metabolic syndrome components.

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.

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=11 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Prevalence of Metabolic Syndrome at Week 24. Metabolic syndrome	6 Participants	1 Participants
Prevalence of Metabolic Syndrome at Week 24. No metabolic syndrome	15 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing metabolic syndrome components.

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.

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Presence of Metabolic Syndrome at Week 48. Metabolic syndrome	7 Participants	0 Participants
Presence of Metabolic Syndrome at Week 48. No metabolic syndrome	14 Participants	13 Participants

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing waist circumference.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=10 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Waist Circumference From Baseline to Week 24	0.90 cm Interval -0.15 to 3.4	0.57 cm Interval -3.87 to 5.8

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing waist circumference.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Waist Circumference From Baseline to Week 48	0.77 cm Interval -2.03 to 2.93	-0.08 cm Interval -4.95 to 5.05

SECONDARY outcome

Timeframe: baseline and week 24

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing waist-to-hip ratio.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=10 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Waist-to-hip Ratio From Baseline to Week 24	0 waist cm : hip cm Interval -0.01 to 0.03	0.01 waist cm : hip cm Interval 0.0 to 0.03

SECONDARY outcome

Timeframe: baseline and week 48

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing waist-to-hip ratio.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=21 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=11 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Waist-to-hip Ratio From Baseline to Week 48	0 waist cm : hip cm Interval -0.01 to 0.02	0.02 waist cm : hip cm Interval -0.02 to 0.04

SECONDARY outcome

Timeframe: 24 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD4+CD38+HLA-DR+ data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=19 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24	0.20 Percent of CD4+ expressing CD38+HLA-DR+ Interval -0.6 to 1.5	-1.35 Percent of CD4+ expressing CD38+HLA-DR+ Interval -2.1 to -0.75

SECONDARY outcome

Timeframe: 24 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD8+CD38+HLA-DR+ data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=19 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24	0.60 Percent of CD8+ expressing CD38+HLA-DR+ Interval -0.6 to 3.0	-0.95 Percent of CD8+ expressing CD38+HLA-DR+ Interval -2.1 to -0.4

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD4+CD38+HLA-DR+ data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48	-0.30 Percent of CD4+ expressing CD38+HLA-DR+ Interval -0.9 to 1.1	-0.60 Percent of CD4+ expressing CD38+HLA-DR+ Interval -1.3 to 0.2

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD8+CD38+HLA-DR+ data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=13 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48	-0.40 Percent of CD8+ expressing CD38+HLA-DR+ Interval -1.55 to 0.85	-0.20 Percent of CD8+ expressing CD38+HLA-DR+ Interval -1.8 to 0.9

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD163+ adipose tissue data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=20 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=12 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48	-0.19 Percent of CD163+ adipose tissue cells Interval -5.55 to 3.76	0.87 Percent of CD163+ adipose tissue cells Interval -2.52 to 2.75

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD4+ lymphoid tissue data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=11 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=6 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.	1 Percent of CD4+ lymphoid tissue cells Interval -5.2 to 3.7	-7.8 Percent of CD4+ lymphoid tissue cells Interval -12.3 to 2.1

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD8+ lymphoid tissue data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=11 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=6 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.	-1.19 Percent of CD8+ lymphoid tissue cells Interval -5.3 to 1.5	3.9 Percent of CD8+ lymphoid tissue cells Interval 1.0 to 9.2

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD163+ lymphoid tissue data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=11 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=6 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.	-0.13 Percent of CD163+ lymphoid tissue cells Interval -0.81 to 0.81	0.15 Percent of CD163+ lymphoid tissue cells Interval -0.77 to 0.69

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD68+ lymphoid tissue data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=11 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=6 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.	-0.02 Percent of CD68+ lymphoid tissue cells Interval -0.48 to 0.49	0.08 Percent of CD68+ lymphoid tissue cells Interval -1.07 to 0.24

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD38+HLA-DR+ on CD4+ lymphoid tissue data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=11 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=6 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.	-0.33 Percent of CD38+HLA-DR+ on CD4+ cells Interval -2.55 to 0.87	0.06 Percent of CD38+HLA-DR+ on CD4+ cells Interval -0.35 to 1.11

SECONDARY outcome

Timeframe: 48 weeks

Population: Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48. Additionally, have non-missing CD38+HLA-DR+ on CD8+ lymphoid tissue data.

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

Outcome measures

Outcome measures
Measure	Arm A: Telmisartan n=11 Participants Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=6 Participants Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.	0.13 Percent of CD38+HLA-DR+ on CD8+ cells Interval -3.95 to 0.63	-0.22 Percent of CD38+HLA-DR+ on CD8+ cells Interval -0.72 to 0.48

Adverse Events

Arm A: Telmisartan

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Arm B: No Study Drug

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Telmisartan n=29 participants at risk Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Arm B: No Study Drug n=15 participants at risk Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Cardiac disorders Angina unstable	0.00% 0/29 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.	6.7% 1/15 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.
Gastrointestinal disorders Diarrhoea	3.4% 1/29 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.	0.00% 0/15 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.
Infections and infestations Herpes zoster disseminated	3.4% 1/29 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.	0.00% 0/15 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.
Investigations Hepatic enzyme increased	3.4% 1/29 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.	0.00% 0/15 • From baseline to Week 48. Protocol definition of Other (Not Including Serious) Adverse Events: 1) signs and symptoms Grade ≥2 and any that led to a change in treatment regardless of grade; 2) all new diagnoses; 3) Grade ≥2 lab values. All lab toxicities that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade. The following labs regardless of grade: creatinine, AST, ALT, hemoglobin, platelet count, fasting lipids and fasting glucose. DAIDS AE Grading Table (V1.0) was used.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place