Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine - Full Text View

Sponsored by:	Università degli Studi dell'Insubria
Information provided by:	Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:	NCT00564057

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: AIDS Blood Pressure Medicines High Blood Pressure

Drug Information available for: Lercanidipine Lercanidipine hydrochloride CV 11974 Candesartan cilexetil

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
1: Experimental candesartan 8-16 mg once daily	Drug: candesartan tablet 8-16 mg once daily, one year
2: Active Comparator 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:

Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. Review.

Gazzaruso C, Bruno R, Garzaniti A, Giordanetti S, Fratino P, Sacchi P, Filice G. Hypertension among HIV patients: prevalence and relationships to insulin resistance and metabolic syndrome. J Hypertens. 2003 Jul;21(7):1377-82.

Friis-Møller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiébaut R, Morfeldt L, De Wit S, Pradier C, Calvo G, Law MG, Kirk O, Phillips AN, Lundgren JD; Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med. 2003 Nov 20;349(21):1993-2003. Erratum in: N Engl J Med. 2004 Feb 26;350(9):955.

Meng Q, Lima JA, Lai H, Vlahov D, Celentano DD, Strathdee S, Nelson KE, Tong W, Lai S. Use of HIV protease inhibitors is associated with left ventricular morphologic changes and diastolic dysfunction. J Acquir Immune Defic Syndr. 2002 Jul 1;30(3):306-10.

Lindholm LH, Persson M, Alaupovic P, Carlberg B, Svensson A, Samuelsson O. Metabolic outcome during 1 year in newly detected hypertensives: results of the Antihypertensive Treatment and Lipid Profile in a North of Sweden Efficacy Evaluation (ALPINE study). J Hypertens. 2003 Aug;21(8):1563-74.

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

Keywords provided by Università degli Studi dell'Insubria:

HIV
blood pressure
left ventricle
metabolic profile
treatment experienced

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Lercanidipine
Acquired Immunodeficiency Syndrome
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Immunologic Deficiency Syndromes

Angiotensin II Type 1 Receptor Blockers
Virus Diseases
Candesartan cilexetil
Calcium, Dietary
HIV Infections
Sexually Transmitted Diseases
Candesartan
Retroviridae Infections
Hypertension

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Infection
Membrane Transport Modulators
Candesartan cilexetil
Therapeutic Uses
Cardiovascular Diseases
Retroviridae Infections
RNA Virus Infections
Immune System Diseases
Lercanidipine

Acquired Immunodeficiency Syndrome
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Angiotensin II Type 1 Receptor Blockers
HIV Infections
Sexually Transmitted Diseases
Candesartan
Lentivirus Infections
Hypertension

ClinicalTrials.gov processed this record on July 02, 2009