E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Human Immunodeficiency Virus (typeI) Infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020192 |
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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 evaluate the non-inferiority of FTC/RPV/TDF relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) and two nucleoside reverse transcriptase inhibitors (NRTIs) in maintaining HIV-1 RNA <50 copies/mL at Week 24. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the change from baseline in fasting lipid parameters (total cholesterol, LDL and HDL cholesterol, and triglycerides) over 24 and 48 weeks. To evaluate the safety and tolerability of each treatment arm over 24 and 48 weeks. To evaluate the change from baseline in CD4 cell count in each treatment arm at 24 and 48 weeks. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
HIV-infected patients matching the following criteria: •Currently receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIs continuously for ≥6 months preceding the screening visit; •Have plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels (according to the local assay being used) for ≥6 months prior to the screening visit and have HIV RNA <50 copies/mL at the screening visit; •Be on their first or second antiretroviral drug regimen; if on their second regimen, must not have had HIV-1 RNA >50 copies/mL at the time of the change in antiretroviral drugs, nor ever experienced two consecutive HIV RNA >50 copies/mL after first achieving HIV RNA < 50 copies/mL; •Adequate renal function: Estimated glomerular filtration rate ≥70 mL/min according to the Cockcroft Gault formula; •No previous use of any approved or experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) drug for any length of time; •Hepatic transaminases (AST and ALT) ≤5 x upper limit of normal (ULN; •Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents at any time in the past including, but not limited to the RT resistance mutations K65R, K101E/P, E138G/K/R/Q, Y181C/I/V, M184V/I, or H221Y; . No proven or suspected acute hepatitis in the 30 days prior to study entry; . No anticipated need to initiate drugs during the study that are contraindicated. |
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E.4 | Principal exclusion criteria |
• A new AIDS defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria) (refer to Appendix 5) • Females who are breastfeeding • Positive serum pregnancy test (female of childbearing potential) • Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance. • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi`s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the proportion of subjects with HIV-1 RNA <50 copies/mL at week 24 as defined by FDA snapshot analysis. |
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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 | No |
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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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.8.3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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Dopo la settimana 48 , tutti i soggetti completeranno un follow-up ao 30 gioni. I soggetti avranno l`opzione di continuare il trattamento in studio fino alla commercializzazione o fino a decisione di Gilead Sciences di interrompere lo sviluppo. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |