HIV InfectionsPhase 4NCT00564057
Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine
A Phase 4 study testing candesartan and lercanidipine in people with HIV Infections and Hypertension, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Hypertension
- What is being tested?
- candesartan and lercanidipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2007to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection
- office blood pressure > 140/90 mmHg
- no antihypertensive treatment
- good quality echocardiogram
Who cannot join
- cardiovascular diseases
- hypothyroidism
- diabetes
- secondary hypertension
- hepatic and renal failure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Insubria, Department of Clinical Medicine
Varese, 21100
About this study
Official title: Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine
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.
- Conditions
- HIV Infections, Hypertension
- Being tested
- candesartan, lercanidipine
- Keywords
- HIV, blood pressure, left ventricle, metabolic profile, treatment experienced
- Medical subject headings
- HIV Infections, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartanDrug
tablet 8-16 mg once daily, one year
lercanidipineDrug
tablets 10-20 mg once daily, one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | candesartan 8-16 mg once daily Receives: Drug: candesartan |
| 2 | Active comparator | lercanidipine 10-20 mg once daily Receives: Drug: lercanidipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
morpho-functional left ventricle characteristics
Measured: one year
metabolic profile
Measured: one year
Secondary outcomes (1)
systolic and diastolic blood pressure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startSep 2007
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Investigators
- anna maria grandi, MD, Study chair, University of Insubria, Varese, ITALYpaolo grossi, MD, Principal investigator, University of Insubria, Varese, Italyandrea maria maresca, MD, Principal investigator, University of Insubria, Varese, Italyeleonora nicolini, MD, Principal investigator, University of Insubria, Varese, Italymassimo giola, MD, Principal investigator, University of Insubria, Varese, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564057
- Sponsor's protocol ID
- 44758
- Status last verified
- Nov 2007
- First submitted
- 26 Nov 2007
- Last updated
- 6 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. doi: 10.1016/j.amjmed.2005.01.047.
PubMed 15903292Gazzaruso 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. doi: 10.1097/01.hjh.0000059071.43904.dc.
PubMed 12817187Friis-Moller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiebaut 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. doi: 10.1056/NEJMoa030218.
PubMed 14627784Meng 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. doi: 10.1097/00126334-200207010-00006.
PubMed 12131567Lindholm 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. doi: 10.1097/01.hjh.0000084723.53355.76.
PubMed 12872052
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine
- ClinicalTrials.gov ID
- NCT00564057
- Acronym / sponsor ID
- 44758
- Conditions
- HIV Infections, Hypertension
- Keywords
- HIV, blood pressure, left ventricle, metabolic profile, treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: candesartancandesartan 8-16 mg once daily |
| 2 | Active comparator | Drug: lercanidipinelercanidipine 10-20 mg once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infection
- office blood pressure > 140/90 mmHg
- no antihypertensive treatment
- good quality echocardiogram
Key exclusion criteria (5 listed)
- cardiovascular diseases
- hypothyroidism
- diabetes
- secondary hypertension
- hepatic and renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| candesartantablet 8-16 mg once daily, one year | Drug | 1 |
| lercanidipinetablets 10-20 mg once daily, one year | Drug | 2 |
Primary outcome
morpho-functional left ventricle characteristics
Time frame: one year
metabolic profile
Time frame: one year
1 secondary outcome
systolic and diastolic blood pressure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2007.
- Background: PubMed 15903292Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. doi: 10.1016/j.amjmed.2005.01.047.
- Background: PubMed 12817187Gazzaruso 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. doi: 10.1097/01.hjh.0000059071.43904.dc.
- Background: PubMed 14627784Friis-Moller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiebaut 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. doi: 10.1056/NEJMoa030218.
- Background: PubMed 12131567Meng 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. doi: 10.1097/00126334-200207010-00006.
- Background: PubMed 12872052Lindholm 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. doi: 10.1097/01.hjh.0000084723.53355.76.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
anna maria grandi, MD study chair
University of Insubria, Varese, ITALY
paolo grossi, MD principal investigator
University of Insubria, Varese, Italy
andrea maria maresca, MD principal investigator
University of Insubria, Varese, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing candesartan and lercanidipine in people with HIV Infections and Hypertension, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact anna maria grandi, MD (+39 0332 278403, amgrandi@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morpho-functional left ventricle characteristics (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00564057, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2007.