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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01928927
First Posted: August 27, 2013
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
Results First Submitted: March 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV-1 Infection
Intervention: Drug: Telmisartan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Arm A: Telmisartan

Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Arm B: No Study Drug

Participants will receive no study drug and will follow week 0-48 evaluation schedule.

Control


Participant Flow:   Overall Study
    Arm A: Telmisartan   Arm B: No Study Drug
STARTED   29   15 
COMPLETED   27   14 
NOT COMPLETED   2   1 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Step 2 randomized participants with data available for specific measures.

Reporting Groups
  Description
Arm A: Telmisartan

Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Telmisartan

Arm B: No Study Drug

Participants received no study drug and were followed week 0-48 evaluation schedule.

Control

Total Total of all reporting groups

Baseline Measures
   Arm A: Telmisartan   Arm B: No Study Drug   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   15   44 
Age 
[Units: Years]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
   47 
 (41 to 51) 
 50 
 (39 to 52) 
 48 
 (41 to 52) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
18-29 years      0   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  20.0%      15  34.1% 
50-59 years      11  37.9%      6  40.0%      17  38.6% 
60-69 years      0   0.0%      2  13.3%      2   4.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
Female      2   6.9%      1   6.7%      3   6.8% 
Male      27  93.1%      14  93.3%      41  93.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
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%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      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   0.0%      1   2.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
White Non-Hispanic      16  55.2%      6  40.0%      22  50.0% 
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   0.0%      1   2.3% 
IV drug history 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
No History      25  86.2%      13  86.7%      38  86.4% 
Previous History      4  13.8%      2  13.3%      6  13.6% 
BMI 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
   25.4 
 (23.3 to 29.8) 
 23.7 
 (21.4 to 26.6) 
 25.0 
 (22.6 to 28.4) 
Waist circumference [1] 
[Units: Cm]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 28   14   42 
   92 
 (85 to 100) 
 86 
 (81 to 96) 
 88 
 (84 to 99) 
[1] Participants with non-missing waist circumference data.
Waist-to-hip ratio [1] 
[Units: Ratio]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 28   14   42 
   0.94 
 (0.91 to 0.98) 
 0.91 
 (0.86 to 0.95) 
 0.93 
 (0.89 to 0.97) 
[1] Participants with non-missing waist circumference data.
CD4+ [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 28   15   43 
   604 
 (438 to 812) 
 556 
 (444 to 906) 
 588 
 (444 to 841) 
[1] Participants with non-missing CD4+ data.
HIV-1 RNA 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
<40 copies/ml      24  82.8%      11  73.3%      35  79.5% 
40 - <200 copies/ml      3  10.3%      3  20.0%      6  13.6% 
>= 200 copies/ml      2   6.9%      1   6.7%      3   6.8% 
Lymphoid Tissue Collagen I Deposition [1] 
[Units: Percent area stain positive]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 24   15   39 
   15.3 
 (6.5 to 22.1) 
 12.6 
 (10.3 to 19.1) 
 13.9 
 (8.4 to 20.8) 
[1] Participants with non-missing lymphoid tissue collagen I deposition data.
Adipose Tissue Collagen I Deposition 
[Units: Percent area stain positive]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 29   15   44 
   1.51 
 (0.54 to 2.69) 
 2.83 
 (1.36 to 4.53) 
 2.11 
 (0.63 to 3.45) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

2.  Primary:   Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

3.  Secondary:   Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

4.  Secondary:   Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

5.  Secondary:   Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

6.  Secondary:   Highest Grade Non-biopsy-related Adverse Event   [ Time Frame: after baseline to week 48 ]

7.  Secondary:   Change in IL-6 From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

8.  Secondary:   Change in IL-6 From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

9.  Secondary:   Change in IL-6 From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

10.  Secondary:   Change in IL-7 From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

11.  Secondary:   Change in IL-7 From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

12.  Secondary:   Change in IL-7 From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

13.  Secondary:   Change in Adiponectin From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

14.  Secondary:   Change in Adiponectin From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

15.  Secondary:   Change in Adiponectin From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

16.  Secondary:   Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

17.  Secondary:   Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

18.  Secondary:   Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

19.  Secondary:   Change in Hyaluronic Acid From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

20.  Secondary:   Change in Hyaluronic Acid From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

21.  Secondary:   Change in Hyaluronic Acid From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

22.  Secondary:   Change in sCD14 From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

23.  Secondary:   Change in sCD14 From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

24.  Secondary:   Change in sCD14 From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

25.  Secondary:   Change in sCD163 From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

26.  Secondary:   Change in sCD163 From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

27.  Secondary:   Change in sCD163 From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

28.  Secondary:   Change in TGF-β1 From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

29.  Secondary:   Change in TGF-β1 From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

30.  Secondary:   Change in TGF-β1 From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

31.  Secondary:   Change in TGF-β2 From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

32.  Secondary:   Change in TGF-β2 From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

33.  Secondary:   Change in TGF-β2 From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

34.  Secondary:   Change in TGF-β3 From Baseline to Week 4   [ Time Frame: baseline and week 4 ]

35.  Secondary:   Change in TGF-β3 From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

36.  Secondary:   Change in TGF-β3 From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

37.  Secondary:   Change in Circulating CD4+ T Cell Count From Baseline to Week 12   [ Time Frame: baseline and week 12 ]

38.  Secondary:   Change in Circulating CD4+ T Cell Count From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

39.  Secondary:   Change in Circulating CD4+ T Cell Count From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

40.  Secondary:   Change in Circulating CD8+ T Cell Count From Baseline to Week 12   [ Time Frame: baseline and week 12 ]

41.  Secondary:   Change in Circulating CD8+ T Cell Count From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

42.  Secondary:   Change in Circulating CD8+ T Cell Count From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

43.  Secondary:   Change in Fasting Glucose From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

44.  Secondary:   Change in Fasting HDL Cholesterol From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

45.  Secondary:   Change in Fasting Insulin From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

46.  Secondary:   Change in Fasting LDL Cholesterol From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

47.  Secondary:   Change in Fasting Total Cholesterol From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

48.  Secondary:   Change in Fasting Triglycerides From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

49.  Secondary:   Change in HOMA-IR From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

50.  Secondary:   Prevalence of Metabolic Syndrome at Week 24.   [ Time Frame: Week 24 ]

51.  Secondary:   Presence of Metabolic Syndrome at Week 48.   [ Time Frame: Week 48 ]

52.  Secondary:   Change in Waist Circumference From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

53.  Secondary:   Change in Waist Circumference From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

54.  Secondary:   Change in Waist-to-hip Ratio From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

55.  Secondary:   Change in Waist-to-hip Ratio From Baseline to Week 48   [ Time Frame: baseline and week 48 ]

56.  Secondary:   Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24   [ Time Frame: 24 weeks ]

57.  Secondary:   Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24   [ Time Frame: 24 weeks ]

58.  Secondary:   Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48   [ Time Frame: 48 weeks ]

59.  Secondary:   Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48   [ Time Frame: 48 weeks ]

60.  Secondary:   Change in Inflammatory Cell Population Type and Number in Lymphoid Tissue Biopsy Specimens From Baseline to Week 48   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

61.  Secondary:   Change in Inflammatory Cell Population Type and Number in Adipose Tissue Biopsy Specimens From Baseline to Week 48   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

62.  Secondary:   Change in the Proportion of CD4+ T Cells in Lymphoid Tissue From Baseline to Week 48.   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com



Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01928927     History of Changes
Other Study ID Numbers: ACTG A5317
UM1AI068636 ( U.S. NIH Grant/Contract )
First Submitted: August 22, 2013
First Posted: August 27, 2013
Results First Submitted: March 1, 2017
Results First Posted: April 12, 2017
Last Update Posted: September 8, 2017