A randomised, controlled, open-label trial to compare brachial artery reactivity and cardiovascular risk of a treatment simplification by darunavir/ritonavir (DRV/r) 800/100 mg O.D. versus a triple combination therapy containing DRV/r in HIV-1 infected subjects with undetectable plasma HIV-1 RNA on their current treatments. - ND

Conditions: HIV-1 Infection
MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

Registration Number: EUCTR2008-002383-34-IT

Lead Sponsor: JANSSEN-CILAG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

·Patients with documented HIV-1 infection. ·Male or female aged > 18 years old. ·Patients who have voluntarily provided signed and dated consent forms. ·Patients have been receiving HAART for at least 24 weeks. ·Patients are currently on their first-line treatment and this is HAART. Note: HAART is defined as the combination of 2 NRTIs with at least 1 additional ARV from the NNRTI and/or PI class*. A first line regimen with 3 NRTIs is allowed. ·Plasma HIV-1 RNA < 50 cp/ml for at least 24 weeks before screening. ·Patient taking the same ARV combination for at least 8 weeks before screening. ·Preference for a more convenient regimen and/or any current or history of toxicity on actual regimen (examples of toxicities: CNS, gastrointestinal disturbances, jaundice, anaemia, nausea, neuropathy, paresthesia, hyperlipidaemia, glucose intolerance or diabetes, nephrolithiasis, lipodystrophy, hepatotoxicity, rash and skin related events, any other AE or intolerability or laboratory abnormalities caused by current HAART). ·CD4 > 100/mm3 at the start of HAART and > 200/mm3 at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·History of coronary heart disease, (history of myocardial infarction, coronary bypass surgery, coronary angioplasty, or angina pectoris with a positive stress test or angiographic documentation), uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >100 mmHg) peripheral vascular disease (claudication, angioplasty, or bypass procedure), or cerebrovascular disease (stroke or TIA with documented carotid or aortic atherosclerosis). ·Pregnant or breast-feeding ·Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study ·History of virological failure on HAART. ·History of plasma HIV-1 RNA > 500 copies/ml after initial full virological suppression while on ARV therapy. ·Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency). ·Patients diagnosed with acute viral hepatitis at screening. ·Patients co-infected with hepatitis B. Note: Patients co-infected with chronic hepatitis C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the study period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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