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

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ClinicalTrials.gov Identifier: NCT00564057
Recruitment Status : Unknown
Verified November 2007 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
First Posted : November 27, 2007
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Hypertension Drug: candesartan Drug: lercanidipine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2007
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: November 2007

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Candesartan
Candesartan cilexetil
Lercanidipine
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators