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

Tracking Information

First Received Date ^ICMJE

November 26, 2007

Last Updated Date

December 5, 2007

Start Date ^ICMJE

September 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

morpho-functional left ventricle characteristics [ Time Frame: one year ]
metabolic profile [ Time Frame: one year ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00564057 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

systolic and diastolic blood pressure [ Time Frame: one year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections
Hypertension

Intervention ^ICMJE

Drug: candesartan
tablet 8-16 mg once daily, one year
Drug: lercanidipine
tablets 10-20 mg once daily, one year

Study Arm (s)

Experimental: 1
candesartan 8-16 mg once daily

Intervention: Drug: candesartan
Active Comparator: 2
lercanidipine 10-20 mg once daily

Intervention: Drug: lercanidipine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: anna maria grandi, MD

+39 0332 278403

amgrandi@libero.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00564057

Other Study ID Numbers ^ICMJE

44758

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Università degli Studi dell'Insubria

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Università degli Studi dell'Insubria

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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