- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01578772
A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease
Telmisartan and Flow-Mediated Dilatation in Older HIV-Infected Patients at Risk for Cardiovascular Disease
This research study is to see whether blood vessel function, an early sign of heart disease, improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators will be looking at how a blood vessel in the arm, called the brachial artery, changes in response to stress before and after taking telmisartan. To determine how well the blood vessel functions, the investigators will be using an ultrasound machine.
Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat blood pressure, but has been shown to improve blood vessel function in HIV-negative people with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this trial is sponsored by The Campbell Foundation.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90035
- UCLA CARE Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- HIV positive men and women > 50 years of age.
- HIV-1 RNA documented to be < 50 copies/mL at screening and undetectable by assay of choice (< 50 or < 400 copies/mL) for at least 12 weeks prior to entry.
- Current ART with a suppressive, highly active regimen. Subjects must not have changed ART in the 12 weeks prior to entry, and must not be planning to change ART for the 12-week study duration.
- Systolic blood pressure > 110mmHg.
- One or more risk factors for CVD (smoking, hypertension, hyperlipidemia, diabetes mellitus). Note: family history of early heart disease alone will not be a sufficient entry criterion.
- Ability and willingness of subject to provide informed consent.
Exclusion Criteria:
- Pregnancy (current or within the past 6 months) or nursing.
- Uncontrolled hypertension:
- Prohibited concomitant medications: Other members of the angiotensin receptor-blocking class (losartan, irbesartan, olmesartan, valsartan, candesartan; wash-out period allowed), nelfinavir, and etravirine. Subjects taking nelfinavir or etravirine will be excluded due to the possibility of increased drug levels via inhibition of cytochrome P-450 2C19.
Note 1: Subjects requiring amifostine or rituximab must be aware of the increased risk of orthostatic hypotension with the addition of telmisartan. Any subject requiring lithium therapy while on study must have lithium levels monitored closely by their outside physician. All subjects on the above listed medications should provide documentation that their physician is aware of the study protocol.
Note 2: Subjects taking thiazolidinediones must be on stable dosing (> 12 weeks) and must agree to refrain from dose titration for the 12-week study duration.
- Untreated hyperlipidemia: Subjects must be willing to abstain from initiating therapy for the 12-week study duration. Subjects on a stable (> 12 weeks) lipid-lowering regimen must be willing to remain on their current dose for the 12-week study duration.
- Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin-sensitizing agents (metformin/biguanides) for the 12-week study duration. Titration of other diabetes (except thiazolidinediones, see 4.2.3) medications will be permitted.
- Screening laboratory values as follows:
- ANC < 750 cells/mm3
- Hemoglobin < 10 gm/dL
- Creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault equation using ideal body weight)
- AST or ALT > 3 times ULN
- Known, untreated, renal artery stenosis.
- Unstable coronary artery disease/angina, decompensated congestive heart failure, or predicted need for cardiovascular surgery within the study period.
- History of intolerance to any member of the angiotensin receptor blocker class of agents.
- Need for ongoing potassium supplementation.
- Active, untreated opportunistic and/or AIDS-defining illnesses.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Telmisartan
Open label
|
80mg tablets po daily for 6 weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy
Tidsram: 6 weeks (after baseline)
|
Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.
|
6 weeks (after baseline)
|
6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy
Tidsram: 6 weeks (after baseline)
|
Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.
|
6 weeks (after baseline)
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Jordan E. Lake, MD, University of California, Los Angeles
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- miFMD
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Endotel dysfunktion
-
Centre Hospitalier Régional Metz-ThionvilleAvslutadDescemets Stripping Automated Endothelial Keratoplasty
-
Oslo University HospitalRekryteringDescemet Stripping Automated Endothelial Keratoplasty (DSAEK) | Descemet Membrane Endothelial Keratoplasty (DMEK)Norge
-
Stealth BioTherapeutics Inc.AvslutadFuchs' corneal endothelial dystrophy (FCED)Förenta staterna
-
Oslo University HospitalOkändKornealdystrofier, ärftlig | Fuchs endoteldystrofi | Korneatransplantation | Descemet Stripping Automated Endothelial KeratoplastyNorge
-
Singapore National Eye CentreNational University, SingaporeAvslutad
-
University of WaterlooAvslutadMeibomian Gland Dysfunction (MGD)Kanada
-
Grand Valley State UniversityAnmälan via inbjudanMetabolic Associated-dysfunction Steatotic Lever Disease (MASLD) | Metabolic Associated-dysfunction Steatohepatit (MASH)Förenta staterna
-
Azura OphthalmicsThe University of New South WalesAvslutadMeibomian Gland Dysfunction (MGD) | Kontaktlinsobehag (CLD)Australien
-
Johnson & Johnson Surgical Vision, Inc.AvslutadGrå starr | Meibomian Gland Dysfunction (MGD)Förenta staterna
-
Centre Hospitalier Régional Metz-ThionvilleAvslutadPseudofakisk bullös keratopati | Fuchs endotelial hornhinnedystrofi | Descemet Membrane Endothelial Keratoplasty | TransplantatavskiljningFrankrike
Kliniska prövningar på Telmisartan
-
Emory UniversityNational Institute on Aging (NIA)AvslutadAlzheimers sjukdomFörenta staterna
-
Boehringer IngelheimAvslutad
-
Boehringer IngelheimAvslutadDiabetiska nefropatierJapan
-
Boehringer IngelheimAvslutad