A phase IV study to assess the feasibility of substituting double ritonavir-boosted protease inhibitors (PI) with ritonavir-boosted darunavir (DRV/r) in HIV-infected individuals with viral suppression on highly active antiretroviral therapy (HAART) - Double PI to darunavir switch study
- Conditions
- HIV
- Registration Number
- EUCTR2007-000932-19-GB
- Lead Sponsor
- St Stephen's AIDS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
- 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 < 50 copies/mL for six months or longer
- The subject has a CD4+ count above 100 cells/mL
- = 3 DRV associated mutations on previous genotypic resistance test –or if no resistance test available, likely to have = 4 protease inhibitor mutations based on their clinical history
- If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception
- 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
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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Secondary Objective: •To investigate the immunological response in subjects switching from double ritonavir-boosted PI to DRV/r.<br> •To investigate whether it is possible to improve the quality of life in individuals by changing from double ritonavir-boosted PI to DRV/r.<br> •An evaluation of the safety of switching to DRV/r<br> •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.<br><br><br>
- Secondary Outcome Measures
Name Time Method