HIV-1 InfectionPhase 2TRAFICNCT01928927

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

A Phase 2 study testing Telmisartan in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: Telmisartan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 12 sitesin 2 countries
Study dates: Jan 2014to Mar 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States11 sites

University of Colorado Hospital CRS (6101)
Aurora, Colorado, 80045
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, 02114
Unc Aids Crs (3201)
Chapel Hill, North Carolina, 27514
Univ. of Cincinnati CRS (2401)
Cincinnati, Ohio, 45267
Case CRS (2501)
Cleveland, Ohio, 44106
Houston AIDS Research Team CRS (31473)
Houston, Texas, 77030
UCLA CARE Center CRS (601)
Los Angeles, California, 90035
Vanderbilt Therapeutics CRS (3652)
Nashville, Tennessee, 37232
University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)
Rochester, New York, 14642
University of Washington AIDS CRS (1401)
Seattle, Washington, 98104
Washington U CRS (2101)
St Louis, Missouri, 63110

Other trials in United States

Puerto Rico1 site

Puerto Rico-AIDS CRS (5401)
San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: Effects of Telmisartan on Fibrotic and Inflammatory Contributors to End-Organ Disease in HIV-Infected Patients Well Controlled on Antiretroviral Therapy

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.

Read the 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.

Conditions: HIV-1 Infection
Being tested: Telmisartan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01928927
Study group	Role	What they receive
Arm A: Telmisartan	Experimental	Not described Receives: Drug: Telmisartan
Arm B: No Study Drug	No intervention	Participants received no study drug and followed the week 0-48 evaluation schedule.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (64)

Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Highest Grade Non-biopsy-related Adverse Event
Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant.
Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table.
NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol.
Measured: after baseline to week 48
Change in IL-6 From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in IL-6 From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in IL-6 From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in IL-7 From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in IL-7 From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in IL-7 From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Adiponectin From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in Adiponectin From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in Adiponectin From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Hyaluronic Acid From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in Hyaluronic Acid From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in Hyaluronic Acid From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in sCD14 From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in sCD14 From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in sCD14 From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in sCD163 From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in sCD163 From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in sCD163 From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in TGF-β1 From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in TGF-β1 From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in TGF-β1 From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in TGF-β2 From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in TGF-β2 From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in TGF-β2 From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in TGF-β3 From Baseline to Week 4
Absolute change was calculated as the value at week 4 minus the value at baseline.
Measured: baseline and week 4
Change in TGF-β3 From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in TGF-β3 From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Circulating CD4+ T Cell Count From Baseline to Week 12
Absolute change was calculated as the value at week 12 minus the value at baseline.
Measured: baseline and week 12
Change in Circulating CD4+ T Cell Count From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in Circulating CD4+ T Cell Count From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Circulating CD8+ T Cell Count From Baseline to Week 12
Absolute change was calculated as the value at week 12 minus the value at baseline.
Measured: baseline and week 12
Change in Circulating CD8+ T Cell Count From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in Circulating CD8+ T Cell Count From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Fasting Glucose From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Fasting HDL Cholesterol From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Fasting Insulin From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Fasting LDL Cholesterol From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Fasting Total Cholesterol From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Fasting Triglycerides From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in HOMA-IR From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Prevalence of Metabolic Syndrome at Week 24.
Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40" (101.6 cm) in men, >35" (88.9 cm) in women with the exception of Asian-Americans: >35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.
NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis.
Measured: Week 24
Presence of Metabolic Syndrome at Week 48.
Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40" (101.6 cm) in men, >35" (88.9 cm) in women with the exception of Asian-Americans: >35" (88.9 cm) in men, 31" (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.
Measured: Week 48
Change in Waist Circumference From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in Waist Circumference From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Waist-to-hip Ratio From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: baseline and week 24
Change in Waist-to-hip Ratio From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: baseline and week 48
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: 24 weeks
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24
Absolute change was calculated as the value at week 24 minus the value at baseline.
Measured: 24 weeks
Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD163+ in Adipose Tissue From Baseline to Week 48
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD4+ in Lymphoid Tissue From Baseline to Week 48.
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD8+ in Lymphoid Tissue From Baseline to Week 48.
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD163+ in Lymphoid Tissue From Baseline to Week 48.
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD68+ in Lymphoid Tissue From Baseline to Week 48.
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD38+HLA-DR+ on CD4+ in Lymphoid Tissue From Baseline to Week 48.
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks
Change in Expression of CD38+HLA-DR+ on CD8+ in Lymphoid Tissue From Baseline to Week 48.
Absolute change was calculated as the value at week 48 minus the value at baseline.
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Mar 2016

First posted27 Aug 2013 (estimated)
Study startJan 2014
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928927
Sponsor's protocol ID: ACTG A5317
Other IDs: UM1AI068636
Acronym: TRAFIC
Status last verified: Jun 2020
First submitted: 22 Aug 2013
Last updated: 3 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Telmisartan on Fibrotic and Inflammatory Contributors to End-Organ Disease in HIV-Infected Patients Well Controlled on Antiretroviral Therapy
ClinicalTrials.gov ID: NCT01928927
Acronym / sponsor ID: TRAFIC / ACTG A5317
Conditions: HIV-1 Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Jan 2014 (actual)
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 27 Aug 2013 (estimated)
Results: Posted 12 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Telmisartan	Experimental	Drug: Telmisartan
Arm B: No Study Drug	No intervention	–Participants received no study drug and followed the week 0-48 evaluation schedule.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TelmisartanParticipants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.	Drug	Arm A: Telmisartan

Primary outcome

Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48
Time frame: 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.
Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Time frame: 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.

64 secondary outcomes

Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48
Time frame: baseline and week 48
Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Time frame: baseline and week 48
Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48
Time frame: baseline and week 48
Highest Grade Non-biopsy-related Adverse Event
Time frame: after baseline to week 48
Change in IL-6 From Baseline to Week 4
Time frame: baseline and week 4
Change in IL-6 From Baseline to Week 24
Time frame: baseline and week 24
Change in IL-6 From Baseline to Week 48
Time frame: baseline and week 48
Change in IL-7 From Baseline to Week 4
Time frame: baseline and week 4
Change in IL-7 From Baseline to Week 24
Time frame: baseline and week 24
Change in IL-7 From Baseline to Week 48
Time frame: baseline and week 48
Change in Adiponectin From Baseline to Week 4
Time frame: baseline and week 4
Change in Adiponectin From Baseline to Week 24
Time frame: baseline and week 24
Change in Adiponectin From Baseline to Week 48
Time frame: baseline and week 48
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4
Time frame: baseline and week 4
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24
Time frame: baseline and week 24
Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48
Time frame: baseline and week 48
Change in Hyaluronic Acid From Baseline to Week 4
Time frame: baseline and week 4
Change in Hyaluronic Acid From Baseline to Week 24
Time frame: baseline and week 24
Change in Hyaluronic Acid From Baseline to Week 48
Time frame: baseline and week 48
Change in sCD14 From Baseline to Week 4
Time frame: baseline and week 4
Change in sCD14 From Baseline to Week 24
Time frame: baseline and week 24
Change in sCD14 From Baseline to Week 48
Time frame: baseline and week 48
Change in sCD163 From Baseline to Week 4
Time frame: baseline and week 4
Change in sCD163 From Baseline to Week 24
Time frame: baseline and week 24
Change in sCD163 From Baseline to Week 48
Time frame: baseline and week 48
Change in TGF-β1 From Baseline to Week 4
Time frame: baseline and week 4
Change in TGF-β1 From Baseline to Week 24
Time frame: baseline and week 24
Change in TGF-β1 From Baseline to Week 48
Time frame: baseline and week 48
Change in TGF-β2 From Baseline to Week 4
Time frame: baseline and week 4
Change in TGF-β2 From Baseline to Week 24
Time frame: baseline and week 24
Change in TGF-β2 From Baseline to Week 48
Time frame: baseline and week 48
Change in TGF-β3 From Baseline to Week 4
Time frame: baseline and week 4
Change in TGF-β3 From Baseline to Week 24
Time frame: baseline and week 24
Change in TGF-β3 From Baseline to Week 48
Time frame: baseline and week 48
Change in Circulating CD4+ T Cell Count From Baseline to Week 12
Time frame: baseline and week 12
Change in Circulating CD4+ T Cell Count From Baseline to Week 24
Time frame: baseline and week 24
Change in Circulating CD4+ T Cell Count From Baseline to Week 48
Time frame: baseline and week 48
Change in Circulating CD8+ T Cell Count From Baseline to Week 12
Time frame: baseline and week 12
Change in Circulating CD8+ T Cell Count From Baseline to Week 24
Time frame: baseline and week 24
Change in Circulating CD8+ T Cell Count From Baseline to Week 48
Time frame: baseline and week 48

Results and safety

Results posted to the registry on 12 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Telmisartan	29	27
Arm B: No Study Drug	15	14

Primary outcome: Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48

Time frame: baseline and week 48. Median (Inter-Quartile Range). Unit: percent area stain positive

Measure	Arm A: Telmisartan n = 17	Arm B: No Study Drug n = 12
Value	-2.44 (-10.60 to 3.77)	-6.08 (-11.66 to 5.84)

Arm A: Telmisartan vs Arm B: No Study Drug: Theta statistic: 0.50 (95% CI 0.26 to 0.73), p = 0.97, Theta statistic; DeLong & Clarke-Pearson

Population analysed: 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.

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

Time frame: baseline and week 48. Median (Inter-Quartile Range). Unit: percent area stain positive

Measure	Arm A: Telmisartan n = 16	Arm B: No Study Drug n = 9
Value	-1.43 (-10.61 to 4.17)	0.36 (-6.57 to 6.41)

Arm A: Telmisartan vs Arm B: No Study Drug: Theta statistic: 0.57 (95% CI 0.31 to 0.83), p = 0.61, Theta statistic; DeLong & Clarke-Pearson

64 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to Week 48.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Telmisartan	3 of 29 (10.3%)	24 of 29 (82.8%)	0 of 29
Arm B: No Study Drug	1 of 15 (6.7%)	10 of 15 (66.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jordan E. Lake, MD, MSc study chair

The University of Texas Health Science Center, Houston

Netanya Sandler, MD study chair

The University of Texas Medical Branch, Galveston

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telmisartan in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48 (time frame: baseline and week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01928927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.