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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
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00564057
First received: November 26, 2007
Last updated: December 5, 2007
Last verified: November 2007
History of Changes
  Purpose

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
Hypertension
 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:

U.S. FDA Resources

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

  Eligibility

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

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

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

Locations
Italy
University of Insubria, Department of Clinical Medicine Recruiting
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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

Publications:

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:
HIV
blood pressure
left ventricle
metabolic profile
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hypertension
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Vascular Diseases
 Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Lercanidipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on March 03, 2013