Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Università degli Studi dell'Insubria.
Recruitment status was  Recruiting
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
First received: November 26, 2007
Last updated: December 5, 2007
Last verified: November 2007
Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are associated with an increased risk of cardiovascular disease: a wide range of alterations in lipid and glucose metabolism has been increasingly recognized in HIV patients treated with HAART. Few data are available on the effects of antihypertensive treatment on cardiac morpho-functional characteristics and metabolic parameters in HIV patients. Aim of the study is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in HIV hypertensive patients.

Condition Intervention Phase
HIV Infections
Drug: candesartan
Drug: lercanidipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine

Resource links provided by NLM:

Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • morpho-functional left ventricle characteristics [ Time Frame: one year ]
  • metabolic profile [ Time Frame: one year ]

Secondary Outcome Measures:
  • systolic and diastolic blood pressure [ Time Frame: one year ]

Estimated Enrollment: 30
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Arms Assigned Interventions
Experimental: 1
candesartan 8-16 mg once daily
Drug: candesartan
tablet 8-16 mg once daily, one year
Active Comparator: 2
lercanidipine 10-20 mg once daily
Drug: lercanidipine
tablets 10-20 mg once daily, one year


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV infection
  • office blood pressure > 140/90 mmHg
  • no antihypertensive treatment
  • good quality echocardiogram

Exclusion Criteria:

  • cardiovascular diseases
  • hypothyroidism
  • diabetes
  • secondary hypertension
  • hepatic and renal failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564057

Contact: anna maria grandi, MD +39 0332 278403 amgrandi@libero.it

University of Insubria, Department of Clinical Medicine Recruiting
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Study Chair: anna maria grandi, MD University of Insubria, Varese, ITALY
Principal Investigator: paolo grossi, MD University of Insubria, Varese, Italy
Principal Investigator: andrea maria maresca, MD University of Insubria, Varese, Italy
Principal Investigator: eleonora nicolini, MD University of Insubria, Varese, Italy
Principal Investigator: massimo giola, MD University of Insubria, Varese, Italy
  More Information

ClinicalTrials.gov Identifier: NCT00564057     History of Changes
Other Study ID Numbers: 44758 
Study First Received: November 26, 2007
Last Updated: December 5, 2007
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi dell'Insubria:
blood pressure
left ventricle
metabolic profile
treatment experienced

Additional relevant MeSH terms:
Antihypertensive Agents
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016