E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the rates of continued virological suppression in subjects switching a double ritonavir-boosted PI for DRV/r to 48 weeks. |
|
E.2.2 | Secondary objectives of the trial |
•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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 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
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects maintaining viral suppression (less than 50 copies/ml) at 48 weeks. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
After the 48 week assessment subjects will return to routine follow-up with their regular clinic doctor. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |