E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008919 |
E.1.2 | Term | Chronic HIV infection |
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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 compare the efficacy of different maintenance strategies based on PI/r monotherapy (LPV/r or DRV/RTV) in HIV-1 infected persons with fully suppressive PI/r-based therapy. |
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E.2.2 | Secondary objectives of the trial |
To compare safety and tolerability of a treatment simplification regimen by a LPV/r or DRV/RTV monotherapy versus a triple PI-based combination therapy. To compare the immune response in terms of changes in the CD4 cell count from baseline over 48 weeks of a treatment simplification regimen by a LPV/r or DRV/RTV monotherapy with a triple PI-based combination therapy. To compare incidence of viral rebound in different treatment groups. To compare the frequency of development of at least one new mutations in RT and PR gene. To compare changes in HIV-DNA from baseline to 24, 48, and 96 weeks; To compare changes in laboratory parameters at all time points from baseline to 48 weeks in different treatment groups; To evaluate and compare the subject-reported adherence and quality of life (QoL) at baseline and the evolution of adherence and QoL over 48 weeks in treatment groups; To compare the antiretroviral drug treatment cost over 48 weeks in all treatment groups |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At least 18 years; Receiving unchanged HAART regimen including two NRTIs and PI/boosted for at least 24 weeks; Plasma HIV-RNA <40 copies/mL for at least 48 weeks prior the screening (two results must be documented); Nadir CD4 >100 cell/mmc, and CD4>200 cell/mmc at screening. No previous history of suspected or confirmed virological failure while receiving a protease inhibitor; Signed and dated written informed consent. |
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E.4 | Principal exclusion criteria |
History of virological failure defined as two consecutive plasma HIV-RNA >50 cp/ml while on previous or current antiretroviral therapy History of any primary PI mutations as defined by the IAS-USA guidelines 2008 Clinical or laboratory evidence of significantly decreased hepatic function or decompensation Diagnosis of acute viral hepatitis at screening Pregnant or breastfeeding woman Acute opportunistic infection requiring treatment (exclusion period: 30 days) Mycobacteriosis under treatment Malignancy requiring chemotherapy or radiotherapy Positive HBsAg HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment. Contraindicated concomitant treatment Previous history of intolerance to LPV/r or DRV/RTV leading to treatment discontinuation Participation in another clinical trial with an on-going exclusion period at screening Subjects which in the opinion of the investigator is unable to complete the study period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of subjects with a plasma HIV-1 RNA <50 cp/ml at weeks 48 by intent to treat (ITT) analyses |
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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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
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 | Yes |
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
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Reasons for early termination of the study by Promoter may include but are not limited to: 1) safety concern 2) sufficient data suggesting lack of efficacy 3) failure to comply with the protocol or inadequate recruitment of subjects. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 6 |