HIV
Conditions
Interventions
Trade Name: Prezista
Product Name: Darunavir
Pharmaceutical Form: Tablet
Trade Name: Norvir
Product Name: Ritonavir
Pha
Sponsors
St Stephen's AIDS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test - At least 18 years of age - Currently on an antiretroviral regimen including a ritonavir boosted double protease inhibitor - The subject is virologically suppressed with a viral load =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women - Previous allergic or hypersensitivity reaction to darunavir - Individuals with minor darunavir exposure - Clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency) - Subjects diagnosed with acute viral hepatitis at screening - Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading table (see appendix 3: DAIDS AE grading Table), with the following exceptions unless clinical assessment foresees an immediate health risk to the subject: Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations; Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4. - Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following exceptions: Stable cutaneous Kaposi’s Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study; Wasting syndrome due to HIV infection. Note: An AIDS defining illness that is not clinically stabilized for at least 30 days will be considered as currently active. - Active drug abuse, including alcohol or recreational drugs, which, in the opinion of the investigator, is expected to interfere withteh subject’s ability to adhere to the study procedures and treatment regimen. Subjects on a methadone program will be accepted if deemed appropriate by the investigator. - Previous or current use of darunavir - Any active clinically significant disease (e.g., tuberculosis, cardiac dysfunction, pancreatitis, acute viral infections) or life threatening disease or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the study. - Any medical or psychiatric condition which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the rates of continued virological suppression in subjects switching a double ritonavir-boosted PI for DRV/r to 48 weeks.;Primary end point(s): The proportion of subjects maintaining viral suppression (less than 50 copies/ml) at 48 weeks.; Secondary Objective: •To investigate the immunological response in subjects switching from double ritonavir-boosted PI to DRV/r. •To investigate whether it is possible to improve the quality of life in individuals by changing from double ritonavir-boosted PI to DRV/r. •An evaluation of the safety of switching to DRV/r •To assess the impact of switching from double ritonavir-boosted PI to DRV/r on insulin sensitivity by euglycaemic clamp method in a sub group of 10 patients. | — |
Countries
United Kingdom
Outcome results
None listed