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Intracellular boosting of HIV protease inhibitors through inhibition of transport - a novel strategy for potentiating HIV therapy - Intracellular Boosting of HIV Protease Inhibitors

Phase 1
Conditions
This study is to evaluate the intracellular boosting effect of furosemide and dipyridamole of the HIV protease inhibitors in HIV positive patients.
Registration Number
EUCTR2008-002627-90-GB
Lead Sponsor
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

•The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
•Male or female patients
•= 18 years
•HIV positive

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 drug sensitivity or drug allergy to lopinavir, ritonavir, furosemide, dipyridamole
•< 18 years
•Pregnant or lactating women
•Women of childbearing age unless using appropriate contraception
•CD4 < 100 x 106.l-1
•Viral load > 5000 copies
•Anaemia (Hb < 10.0 g.dl-1)
•Severe coronary artery disease
•Unstable angina
•Recent myocardial infarction or haemodynamic instability
•Severe hypotension (systolic < 100 mm Hg or diastolic < 60 mm Hg)
•Hypovolaemia or dehydration
•Renal dysfunction (eGFR < 70 ml/min/1.73 m2)
•Severe hypokalaemia (K+ < 3.0 mmol.l-1)
•Severe hyponatraemia (Na+ < 130 mmol.l-1)
•Men with symptomatic urinary outflow obstruction
•Any known bleeding disorders
•INR < 1.5
•Platelets < 100 109.l-1

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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