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

Information source: AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: Telmisartan (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Jordan E. Lake, MD, MSc, Study Chair, Affiliation: UCLA-Care Center
Netanya Sandler, MD, Study Chair, Affiliation: University of Texas Medical Branch at Galveston

Summary

The main goal of this study is to see if a drug called telmisartan will decrease fibrosis (scarring) and inflammation (irritation) in people who are infected with HIV and doing well on their HIV medications. The study is also being 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in percent collagen deposition on lymph node pathology from baseline to week 48

Change in percent collagen deposition on subcutaneous abdominal adipose tissue pathology from baseline to week 48

Secondary outcome:

Change in biomarkers associated with inflammation, coagulation, and oxidative stress from baseline to week 4

Change in biomarkers associated with inflammation, coagulation, and oxidative stress from baseline to week 24

Change in biomarkers associated with inflammation, coagulation, and oxidative stress from baseline to week 48

Change in circulating activated T cells from baseline to week 4

Change in circulating activated T cells from baseline to week 24

Change in circulating activated T cells from baseline to week 48

Change in inflammatory cell population type and number in lymphoid tissue biopsy specimens from baseline to week 48

Change in inflammatory cell population type and number in adipose tissue biopsy specimens from baseline to week 48

Change in the proportion of CD4+ T cells in lymphoid tissue from baseline to week 48.

Change in circulating CD4+ T cell count and phenotype of circulating CD4+ T cells from baseline to weeks 24.

Change in circulating CD4+ T cell count and phenotype of circulating CD4+ T cells from baseline to weeks 48.

Change in markers of peripheral insulin resistance and dyslipidemia from baseline to week 48.

Change in anthropometric measurements from baseline to week 24.

Change in anthropometric measurements from baseline to week 48.

Prevalence of metabolic syndrome at week 24.

Prevalence of metabolic syndrome at week 48.

Safety profile of telmisartan over the 48-week study period.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Step 1 Inclusion Criteria:

- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or

chemiluminescence immunoassay (E/CIA) test kit at any time prior to Step 1 entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV-1 RNA viral load >2000 copies/mL on two occasions.

- On antiretroviral therapy (ART) continuously for ≥48 weeks prior to Step 1 entry.

- Documentation of HIV-1 RNA <50 copies/mL at screening, performed by any US laboratory

that has a CLIA certification or its equivalent.

- At least one HIV-1 RNA level <200 copies/mL in the 48 weeks prior to Step 1 entry

(not including the screening).

- No change in ART regimen in the 12 weeks prior to Step 1 entry (except as noted

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

- No active plan to change ART for the 48-week study duration.

- Body mass index (BMI) 20-35 kg/m2.

- 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.

- Willingness to undergo the week 48 lymphoid and adipose tissue biopsies.

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/mm3

- Hemoglobin ≤10 g/dL

- Platelet count ≤75,000/mm3

- 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.

Locations and Contacts

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

UCLA CARE Center CRS (601), Los Angeles, California 90035, United States

University of Colorado Hospital CRS (6101), Aurora, Colorado 80045, United States

Massachusetts General Hospital ACTG CRS (101), Boston, Massachusetts 02114, United States

Washington U CRS (2101), St. Louis, Missouri 63110, United States

University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787), Rochester, New York 14642, United States

Unc Aids Crs (3201), Chapel Hill, North Carolina 27514, United States

Univ. of Cincinnati CRS (2401), Cincinnati, Ohio 45267, United States

Case CRS (2501), Cleveland, Ohio 44106, United States

Vanderbilt Therapeutics CRS (3652), Nashville, Tennessee 37232, United States

Houston AIDS Research Team CRS (31473), Houston, Texas 77030, United States

Additional Information

Starting date: November 2013
Last updated: August 5, 2015

Page last updated: August 23, 2015

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