Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)

• Sponsor: AIDS Clinical Trials Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01928927
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 58
• Locations: 12
• Arms: 2
• Actual Duration (Months): 26
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The main goal of this study was to see if a drug called telmisartan would decrease fibrosis (scarring) and inflammation (irritation) in people who are infected with HIV and doing well on their HIV medications. The study was also done to see what effects telmisartan has on other signs of disease and inflammation in the body, and to see whether people who have HIV can take telmisartan safely and without side effects that make them want to stop the drug. Telmisartan is FDA-approved for treating high blood pressure and decreasing the chance of heart attacks and strokes in people over the age of 55 years of age who are at high risk for these events.

Condition or Disease	Intervention/Treatment	Phase
HIV-1 Infection	Drug: Telmisartan	Phase 2

Detailed Description

This was a multicenter, randomized, open label, phase IIb, two-arm study to evaluate the effects of telmisartan on fibrotic and inflammatory contributors to end-organ disease in HIV-infected subjects well controlled on antiretroviral therapy (ART). Participants were randomized 2:1 to the telmisartan and control arms. The participants on telmisartan took 40 mg telmisartan daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. The participants in the control arm did not take any study medication, but did undergo all evaluations. All participants were followed for 48 weeks after randomization.

The study clinic visits included Step 1 entry, Step 2 entry, and weeks 4, 12, 24, 36, 48. Biopsies for the primary outcomes were collected at Step 1 entry and Week 48. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, laboratory tests) were done at Step 2 entry and weeks 4, 12, 24, 36, 48.

The co-primary objectives assessed the effects of telmisartan for 48weeks on lymph node and adipose tissue collagen I deposition.

Currently, the results are entered for the primary outcome measures only. The results on the secondary outcomes will be posted when they become available.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Telmisartan on Fibrotic and Inflammatory Contributors to End-Organ Disease in HIV-Infected Patients Well Controlled on Antiretroviral Therapy
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Telmisartan	Drug: Telmisartan; Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
No Intervention: Arm B: No Study Drug Participants received no study drug and followed the week 0-48 evaluation schedule.

Outcome Measures

Primary Outcome Measures

1. Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48 [baseline and 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.

2. Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48 [baseline and 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.

Secondary Outcome Measures

1. Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48 [baseline and week 48]

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

2. Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48 [baseline and week 48]

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

3. Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48 [baseline and week 48]

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

4. Highest Grade Non-biopsy-related Adverse Event [after baseline to week 48]

   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.

5. Change in IL-6 From Baseline to Week 4 [baseline and week 4]

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

6. Change in IL-6 From Baseline to Week 24 [baseline and week 24]

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

7. Change in IL-6 From Baseline to Week 48 [baseline and week 48]

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

8. Change in IL-7 From Baseline to Week 4 [baseline and week 4]

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

9. Change in IL-7 From Baseline to Week 24 [baseline and week 24]

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

10. Change in IL-7 From Baseline to Week 48 [baseline and week 48]

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

11. Change in Adiponectin From Baseline to Week 4 [baseline and week 4]

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

12. Change in Adiponectin From Baseline to Week 24 [baseline and week 24]

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

13. Change in Adiponectin From Baseline to Week 48 [baseline and week 48]

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

14. Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4 [baseline and week 4]

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

15. Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24 [baseline and week 24]

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

16. Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48 [baseline and week 48]

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

17. Change in Hyaluronic Acid From Baseline to Week 4 [baseline and week 4]

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

18. Change in Hyaluronic Acid From Baseline to Week 24 [baseline and week 24]

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

19. Change in Hyaluronic Acid From Baseline to Week 48 [baseline and week 48]

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

20. Change in sCD14 From Baseline to Week 4 [baseline and week 4]

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

21. Change in sCD14 From Baseline to Week 24 [baseline and week 24]

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

22. Change in sCD14 From Baseline to Week 48 [baseline and week 48]

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

23. Change in sCD163 From Baseline to Week 4 [baseline and week 4]

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

24. Change in sCD163 From Baseline to Week 24 [baseline and week 24]

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

25. Change in sCD163 From Baseline to Week 48 [baseline and week 48]

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

26. Change in TGF-β1 From Baseline to Week 4 [baseline and week 4]

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

27. Change in TGF-β1 From Baseline to Week 24 [baseline and week 24]

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

28. Change in TGF-β1 From Baseline to Week 48 [baseline and week 48]

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

29. Change in TGF-β2 From Baseline to Week 4 [baseline and week 4]

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

30. Change in TGF-β2 From Baseline to Week 24 [baseline and week 24]

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

31. Change in TGF-β2 From Baseline to Week 48 [baseline and week 48]

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

32. Change in TGF-β3 From Baseline to Week 4 [baseline and week 4]

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

33. Change in TGF-β3 From Baseline to Week 24 [baseline and week 24]

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

34. Change in TGF-β3 From Baseline to Week 48 [baseline and week 48]

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

35. Change in Circulating CD4+ T Cell Count From Baseline to Week 12 [baseline and week 12]

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

36. Change in Circulating CD4+ T Cell Count From Baseline to Week 24 [baseline and week 24]

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

37. Change in Circulating CD4+ T Cell Count From Baseline to Week 48 [baseline and week 48]

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

38. Change in Circulating CD8+ T Cell Count From Baseline to Week 12 [baseline and week 12]

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

39. Change in Circulating CD8+ T Cell Count From Baseline to Week 24 [baseline and week 24]

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

40. Change in Circulating CD8+ T Cell Count From Baseline to Week 48 [baseline and week 48]

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

41. Change in Fasting Glucose From Baseline to Week 48 [baseline and week 48]

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

42. Change in Fasting HDL Cholesterol From Baseline to Week 48 [baseline and week 48]

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

43. Change in Fasting Insulin From Baseline to Week 48 [baseline and week 48]

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

44. Change in Fasting LDL Cholesterol From Baseline to Week 48 [baseline and week 48]

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

45. Change in Fasting Total Cholesterol From Baseline to Week 48 [baseline and week 48]

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

46. Change in Fasting Triglycerides From Baseline to Week 48 [baseline and week 48]

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

47. Change in HOMA-IR From Baseline to Week 48 [baseline and week 48]

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

48. Prevalence of Metabolic Syndrome at Week 24. [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.

49. Presence of Metabolic Syndrome at Week 48. [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.

50. Change in Waist Circumference From Baseline to Week 24 [baseline and week 24]

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

51. Change in Waist Circumference From Baseline to Week 48 [baseline and week 48]

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

52. Change in Waist-to-hip Ratio From Baseline to Week 24 [baseline and week 24]

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

53. Change in Waist-to-hip Ratio From Baseline to Week 48 [baseline and week 48]

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

54. Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24 [24 weeks]

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

55. Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24 [24 weeks]

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

56. Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48 [48 weeks]

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

57. Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48 [48 weeks]

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

58. Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48 [48 weeks]

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

59. Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48. [48 weeks]

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

60. Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48. [48 weeks]

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

61. Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48. [48 weeks]

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

62. Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48. [48 weeks]

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

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

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

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA CARE Center CRS (601)	Los Angeles	California	United States	90035
2	University of Colorado Hospital CRS (6101)	Aurora	Colorado	United States	80045
3	Massachusetts General Hospital ACTG CRS (101)	Boston	Massachusetts	United States	02114
4	Washington U CRS (2101)	Saint Louis	Missouri	United States	63110
5	University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)	Rochester	New York	United States	14642
6	Unc Aids Crs (3201)	Chapel Hill	North Carolina	United States	27514
7	Univ. of Cincinnati CRS (2401)	Cincinnati	Ohio	United States	45267
8	Case CRS (2501)	Cleveland	Ohio	United States	44106
9	Vanderbilt Therapeutics CRS (3652)	Nashville	Tennessee	United States	37232
10	Houston AIDS Research Team CRS (31473)	Houston	Texas	United States	77030
11	University of Washington AIDS CRS (1401)	Seattle	Washington	United States	98104
12	Puerto Rico-AIDS CRS (5401)	San Juan		Puerto Rico	00935

Sponsors and Collaborators

• AIDS Clinical Trials Group
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Jordan E. Lake, MD, MSc, The University of Texas Health Science Center, Houston
• Study Chair: Netanya Sandler, MD, University of Texas Medical Branch at Galveston

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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)

Publications

None provided.

• Responsible Party: AIDS Clinical Trials Group
• ClinicalTrials.gov Identifier: NCT01928927
• Other Study ID Numbers: ACTG A5317; UM1AI068636
• First Posted: Aug 27, 2013
• Last Update Posted: Aug 3, 2021
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Telmisartan

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Period Title: Overall Study
STARTED	29	15
COMPLETED	27	14
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug	Total
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control	Total of all reporting groups
Overall Participants	29	15	44
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	47	50	48
Age, Customized (Count of Participants)
18-29 years	0 0%	2 13.3%	2 4.5%
30-39 years	6 20.7%	2 13.3%	8 18.2%
40-49 years	12 41.4%	3 20%	15 34.1%
50-59 years	11 37.9%	6 40%	17 38.6%
60-69 years	0 0%	2 13.3%	2 4.5%
Sex: Female, Male (Count of Participants)
Female	2 6.9%	1 6.7%	3 6.8%
Male	27 93.1%	14 93.3%	41 93.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 24.1%	1 6.7%	8 18.2%
Not Hispanic or Latino	22 75.9%	14 93.3%	36 81.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 20.7%	8 53.3%	14 31.8%
White	22 75.9%	7 46.7%	29 65.9%
More than one race	1 3.4%	0 0%	1 2.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic	16 55.2%	6 40%	22 50%
Black Non-Hispanic	5 17.2%	8 53.3%	13 29.5%
Hispanic (Regardless of Race)	7 24.1%	1 6.7%	8 18.2%
More than one race	1 3.4%	0 0%	1 2.3%
IV drug history (Count of Participants)
No History	25 86.2%	13 86.7%	38 86.4%
Previous History	4 13.8%	2 13.3%	6 13.6%
BMI (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	25.4	23.7	25.0
Waist circumference (cm) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cm]	92	86	88
Waist-to-hip ratio (ratio) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ratio]	0.94	0.91	0.93
CD4+ (cells/mm^3) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cells/mm^3]	604	556	588
HIV-1 RNA (Count of Participants)
<40 copies/ml	24 82.8%	11 73.3%	35 79.5%
40 - <200 copies/ml	3 10.3%	3 20%	6 13.6%
>= 200 copies/ml	2 6.9%	1 6.7%	3 6.8%
Lymphoid Tissue Collagen I Deposition (percent area stain positive) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [percent area stain positive]	15.3	12.6	13.9
Adipose Tissue Collagen I Deposition (percent area stain positive) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [percent area stain positive]	1.51	2.83	2.11

Outcome Measures

1. Primary Outcome

Title	Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48
Description	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.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	17	12
Median (Inter-Quartile Range) [percent area stain positive]	-2.44	-6.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Telmisartan, Arm B: No Study Drug
	Comments	Null hypothesis: theta = 0.50
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.97
	Comments	No adjustment for multiple comparisons
	Method	Theta statistic; DeLong & Clarke-Pearson
	Comments
Method of Estimation	Estimation Parameter	Theta statistic
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95%; 0.26 to 0.73
	Parameter Dispersion	Type: Value:
	Estimation Comments	The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is <= a randomly selected outcome from the control arm.

2. Primary Outcome

Title	Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Description	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.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	16	9
Median (Inter-Quartile Range) [percent area stain positive]	-1.43	0.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Telmisartan, Arm B: No Study Drug
	Comments	Null hypothesis: theta = 0.50
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments	No adjustment for multiple comparisons
	Method	Theta statistic; DeLong & Clarke-Pearson
	Comments
Method of Estimation	Estimation Parameter	Theta statistic
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95%; 0.31 to 0.83
	Parameter Dispersion	Type: Value:
	Estimation Comments	The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is <= a randomly selected outcome from the control arm.

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	19	11
Median (Inter-Quartile Range) [percent area stain positive]	0.01	0.61

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and followed the week 0-48 evaluation schedule.
Measure Participants	22	12
Median (Inter-Quartile Range) [percent area stain positive]	-0.82	-4.01

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	12
Median (Inter-Quartile Range) [percent area stain positive]	-0.41	-1.36

6. Secondary Outcome

Title	Highest Grade Non-biopsy-related Adverse Event
Description	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.
Time Frame	after baseline to week 48

Outcome Measure Data

Analysis Population Description

All Step 2 participants

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	29	15
Grade 0	12 41.4%	6 40%
Grade 1	0 0%	0 0%
Grade 2	11 37.9%	3 20%
Grade 3	5 17.2%	5 33.3%
Grade 4	1 3.4%	1 6.7%

7. Secondary Outcome

Title	Change in IL-6 From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	-0.50	-0.01

8. Secondary Outcome

Title	Change in IL-6 From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	-0.53	0.04

9. Secondary Outcome

Title	Change in IL-6 From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [pg/ml]	-0.46	-0.03

10. Secondary Outcome

Title	Change in IL-7 From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	0.48	-0.32

11. Secondary Outcome

Title	Change in IL-7 From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	0.51	-1.36

12. Secondary Outcome

Title	Change in IL-7 From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [pg/ml]	0.06	0.53

13. Secondary Outcome

Title	Change in Adiponectin From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [ng/ml]	177.20	161.00

14. Secondary Outcome

Title	Change in Adiponectin From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [ng/ml]	-582	1222.60

15. Secondary Outcome

Title	Change in Adiponectin From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [ng/ml]	-138.70	113.80

16. Secondary Outcome

Title	Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [ng/ml]	-2.14	-9.10

17. Secondary Outcome

Title	Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [ng/ml]	-13.78	-1.17

18. Secondary Outcome

Title	Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [ng/ml]	-10.76	-6.10

19. Secondary Outcome

Title	Change in Hyaluronic Acid From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [ng/ml]	-0.03	3.14

20. Secondary Outcome

Title	Change in Hyaluronic Acid From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [ng/ml]	-1.62	3.71

21. Secondary Outcome

Title	Change in Hyaluronic Acid From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [ng/ml]	-2.74	-1.79

22. Secondary Outcome

Title	Change in sCD14 From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [mcg/ml]	-0.03	0.05

23. Secondary Outcome

Title	Change in sCD14 From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [mcg/ml]	0.06	-0.08

24. Secondary Outcome

Title	Change in sCD14 From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [mcg/ml]	-0.08	0

25. Secondary Outcome

Title	Change in sCD163 From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [ng/ml]	34.08	0.88

26. Secondary Outcome

Title	Change in sCD163 From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [ng/ml]	58.72	9.58

27. Secondary Outcome

Title	Change in sCD163 From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [ng/ml]	31.14	5.32

28. Secondary Outcome

Title	Change in TGF-β1 From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	793.37	-1074.87

29. Secondary Outcome

Title	Change in TGF-β1 From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	175.02	678.43

30. Secondary Outcome

Title	Change in TGF-β1 From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [pg/ml]	-319.17	-516.45

31. Secondary Outcome

Title	Change in TGF-β2 From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	70.74	-129.40

32. Secondary Outcome

Title	Change in TGF-β2 From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	75.84	-134.68

33. Secondary Outcome

Title	Change in TGF-β2 From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [pg/ml]	44.45	-55.94

34. Secondary Outcome

Title	Change in TGF-β3 From Baseline to Week 4
Description	Absolute change was calculated as the value at week 4 minus the value at baseline.
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	31.26	-95.17

35. Secondary Outcome

Title	Change in TGF-β3 From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [pg/ml]	34.64	-68.01

36. Secondary Outcome

Title	Change in TGF-β3 From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [pg/ml]	-0.47	-55.21

37. Secondary Outcome

Title	Change in Circulating CD4+ T Cell Count From Baseline to Week 12
Description	Absolute change was calculated as the value at week 12 minus the value at baseline.
Time Frame	baseline and week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	20	10
Median (Inter-Quartile Range) [cells/mm^3]	-17.50	59.50

38. Secondary Outcome

Title	Change in Circulating CD4+ T Cell Count From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	20	12
Median (Inter-Quartile Range) [cells/mm^3]	13	61.5

39. Secondary Outcome

Title	Change in Circulating CD4+ T Cell Count From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [cells/mm^3]	9	97

40. Secondary Outcome

Title	Change in Circulating CD8+ T Cell Count From Baseline to Week 12
Description	Absolute change was calculated as the value at week 12 minus the value at baseline.
Time Frame	baseline and week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	20	10
Median (Inter-Quartile Range) [cells/mm^3]	-33.5	83

41. Secondary Outcome

Title	Change in Circulating CD8+ T Cell Count From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	20	12
Median (Inter-Quartile Range) [cells/mm^3]	-3.5	80.5

42. Secondary Outcome

Title	Change in Circulating CD8+ T Cell Count From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [cells/mm^3]	10	97

43. Secondary Outcome

Title	Change in Fasting Glucose From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [mg/dl]	4	2

44. Secondary Outcome

Title	Change in Fasting HDL Cholesterol From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [mg/dl]	-1	-4

45. Secondary Outcome

Title	Change in Fasting Insulin From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	22	13
Median (Inter-Quartile Range) [uIU/ml]	3	0

46. Secondary Outcome

Title	Change in Fasting LDL Cholesterol From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [mg/dl]	-12	-7.4

47. Secondary Outcome

Title	Change in Fasting Total Cholesterol From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [mg/dl]	-8	-2

48. Secondary Outcome

Title	Change in Fasting Triglycerides From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [mg/dl]	7	-16

49. Secondary Outcome

Title	Change in HOMA-IR From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Median (Inter-Quartile Range) [(mg/dl)x(uIU/ml)/405]	0.76	-0.04

50. Secondary Outcome

Title	Prevalence of Metabolic Syndrome at Week 24.
Description	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.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	11
Metabolic syndrome	6 20.7%	1 6.7%
No metabolic syndrome	15 51.7%	10 66.7%

51. Secondary Outcome

Title	Presence of Metabolic Syndrome at Week 48.
Description	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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	13
Metabolic syndrome	7 24.1%	0 0%
No metabolic syndrome	14 48.3%	13 86.7%

52. Secondary Outcome

Title	Change in Waist Circumference From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	20	10
Median (Inter-Quartile Range) [cm]	0.90	0.57

53. Secondary Outcome

Title	Change in Waist Circumference From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	12
Median (Inter-Quartile Range) [cm]	0.77	-0.08

54. Secondary Outcome

Title	Change in Waist-to-hip Ratio From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	baseline and week 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	20	10
Median (Inter-Quartile Range) [waist cm : hip cm]	0	0.01

55. Secondary Outcome

Title	Change in Waist-to-hip Ratio From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	baseline and week 48

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants received no study drug and were followed week 0-48 evaluation schedule. Control
Measure Participants	21	11
Median (Inter-Quartile Range) [waist cm : hip cm]	0	0.02

56. Secondary Outcome

Title	Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	19	12
Median (Inter-Quartile Range) [Percent of CD4+ expressing CD38+HLA-DR+]	0.20	-1.35

57. Secondary Outcome

Title	Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24
Description	Absolute change was calculated as the value at week 24 minus the value at baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	19	12
Median (Inter-Quartile Range) [Percent of CD8+ expressing CD38+HLA-DR+]	0.60	-0.95

58. Secondary Outcome

Title	Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	20	13
Median (Inter-Quartile Range) [Percent of CD4+ expressing CD38+HLA-DR+]	-0.30	-0.60

59. Secondary Outcome

Title	Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	20	13
Median (Inter-Quartile Range) [Percent of CD8+ expressing CD38+HLA-DR+]	-0.40	-0.20

60. Secondary Outcome

Title	Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	20	12
Median (Inter-Quartile Range) [Percent of CD163+ adipose tissue cells]	-0.19	0.87

61. Secondary Outcome

Title	Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	11	6
Median (Inter-Quartile Range) [Percent of CD4+ lymphoid tissue cells]	1	-7.8

62. Secondary Outcome

Title	Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	11	6
Median (Inter-Quartile Range) [Percent of CD8+ lymphoid tissue cells]	-1.19	3.9

63. Secondary Outcome

Title	Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	11	6
Median (Inter-Quartile Range) [Percent of CD163+ lymphoid tissue cells]	-0.13	0.15

64. Secondary Outcome

Title	Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	11	6
Median (Inter-Quartile Range) [Percent of CD68+ lymphoid tissue cells]	-0.02	0.08

65. Secondary Outcome

Title	Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	11	6
Median (Inter-Quartile Range) [Percent of CD38+HLA-DR+ on CD4+ cells]	-0.33	0.06

66. Secondary Outcome

Title	Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.
Description	Absolute change was calculated as the value at week 48 minus the value at baseline.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm A: Telmisartan	Arm B: No Study Drug
Arm/Group Description	Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan	Participants will receive no study drug and will follow week 0-48 evaluation schedule. Control
Measure Participants	11	6
Median (Inter-Quartile Range) [Percent of CD38+HLA-DR+ on CD8+ cells]	0.13	-0.22

Adverse Events

Time Frame	From baseline to Week 48.
Adverse Event Reporting Description	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.
Arm/Group Title	Arm A: Telmisartan		Arm B: No Study Drug
Arm/Group Description	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. Telmisartan		Participants received no study drug and will follow week 0-48 evaluation schedule. Control
All Cause Mortality
	Arm A: Telmisartan		Arm B: No Study Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/15 (0%)
Serious Adverse Events
	Arm A: Telmisartan		Arm B: No Study Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/29 (10.3%)		1/15 (6.7%)
Cardiac disorders
Angina unstable	0/29 (0%)		1/15 (6.7%)
Gastrointestinal disorders
Diarrhoea	1/29 (3.4%)		0/15 (0%)
Infections and infestations
Herpes zoster disseminated	1/29 (3.4%)		0/15 (0%)
Investigations
Hepatic enzyme increased	1/29 (3.4%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Arm A: Telmisartan		Arm B: No Study Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/29 (82.8%)		10/15 (66.7%)
Eye disorders
Eye pruritus	0/29 (0%)		1/15 (6.7%)
Gastrointestinal disorders
Abdominal pain	1/29 (3.4%)		1/15 (6.7%)
Abdominal pain upper	0/29 (0%)		1/15 (6.7%)
Anal fistula	0/29 (0%)		1/15 (6.7%)
Anorectal swelling	0/29 (0%)		1/15 (6.7%)
Gastrooesophageal reflux disease	0/29 (0%)		1/15 (6.7%)
Nausea	3/29 (10.3%)		0/15 (0%)
Perianal erythema	0/29 (0%)		1/15 (6.7%)
Proctalgia	0/29 (0%)		1/15 (6.7%)
Rectal discharge	0/29 (0%)		1/15 (6.7%)
Vomiting	3/29 (10.3%)		0/15 (0%)
General disorders
Chest pain	0/29 (0%)		1/15 (6.7%)
Chills	2/29 (6.9%)		0/15 (0%)
Peripheral swelling	2/29 (6.9%)		0/15 (0%)
Pyrexia	3/29 (10.3%)		0/15 (0%)
Immune system disorders
Seasonal allergy	0/29 (0%)		1/15 (6.7%)
Infections and infestations
Gastroenteritis shigella	2/29 (6.9%)		0/15 (0%)
Perirectal abscess	0/29 (0%)		1/15 (6.7%)
Pneumonia bacterial	2/29 (6.9%)		0/15 (0%)
Urinary tract infection	0/29 (0%)		1/15 (6.7%)
Investigations
Alanine aminotransferase increased	4/29 (13.8%)		1/15 (6.7%)
Aspartate aminotransferase increased	4/29 (13.8%)		3/15 (20%)
Blood alkaline phosphatase increased	0/29 (0%)		1/15 (6.7%)
Blood bilirubin increased	4/29 (13.8%)		2/15 (13.3%)
Blood cholesterol increased	13/29 (44.8%)		4/15 (26.7%)
Blood creatinine increased	2/29 (6.9%)		1/15 (6.7%)
Blood glucose increased	4/29 (13.8%)		1/15 (6.7%)
Blood magnesium decreased	2/29 (6.9%)		1/15 (6.7%)
Blood phosphorus decreased	7/29 (24.1%)		3/15 (20%)
Blood sodium decreased	7/29 (24.1%)		2/15 (13.3%)
Low density lipoprotein increased	13/29 (44.8%)		4/15 (26.7%)
Neutrophil count decreased	0/29 (0%)		1/15 (6.7%)
Platelet count decreased	2/29 (6.9%)		0/15 (0%)
Weight decreased	2/29 (6.9%)		1/15 (6.7%)
Musculoskeletal and connective tissue disorders
Back pain	2/29 (6.9%)		0/15 (0%)
Pain in extremity	0/29 (0%)		1/15 (6.7%)
Rotator cuff syndrome	0/29 (0%)		1/15 (6.7%)
Nervous system disorders
Headache	2/29 (6.9%)		0/15 (0%)
Psychiatric disorders
Anxiety	2/29 (6.9%)		0/15 (0%)
Sleep disorder	2/29 (6.9%)		0/15 (0%)
Renal and urinary disorders
Dysuria	0/29 (0%)		1/15 (6.7%)
Reproductive system and breast disorders
Penile discharge	0/29 (0%)		1/15 (6.7%)
Penile pain	0/29 (0%)		1/15 (6.7%)
Respiratory, thoracic and mediastinal disorders
Cough	4/29 (13.8%)		1/15 (6.7%)
Oropharyngeal pain	1/29 (3.4%)		1/15 (6.7%)
Rhinitis allergic	0/29 (0%)		1/15 (6.7%)
Rhinorrhoea	2/29 (6.9%)		1/15 (6.7%)
Sneezing	0/29 (0%)		1/15 (6.7%)
Skin and subcutaneous tissue disorders
Erythema	2/29 (6.9%)		0/15 (0%)
Vascular disorders
Peripheral arterial occlusive disease	0/29 (0%)		1/15 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.