E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 infection |
Infezione da HIV-1 |
|
E.1.1.1 | Medical condition in easily understood language |
HIV-1 infection |
Infezione da HIV-1 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
1. To evaluate the safety and tolerability of Doravirine/Islatravir (DOR/ISL) as assessed by accumulated safety data at Week 48 |
1. Valutare la sicurezza e la tollerabilità di Doravirina/Islatravir (DOR/ISL) in base al riesame dei dati di sicurezza accumulati fino alla Settimana 48 |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Type of Participant and Disease Characteristics 1. Is currently receiving DOR/ISL adult FDC tablet in a Merck-sponsored clinical study and has completed the last treatment visit. 2. Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate. Demographics 3. Is male or female and >=35 kg at the time of signing the informed consent/assent. Contraception/Pregnancy 1. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP OR • Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 6 weeks after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. - A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention. - If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. - Additional requirements for pregnancy testing during and after study intervention are in Appendix 2. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Informed Consent/Assent 4. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. |
Tipo di partecipante e caratteristiche della malattia 1. Sta attualmente ricevendo la compressa FDC per adulti DOR/ISL in uno studio clinico sponsorizzato da Merck e ha completato l'ultima visita di trattamento 2. Lo sperimentatore ritiene che abbia tratto beneficio clinico dalla somministrazione di DOR/ISL e per coloro ai quali un ulteriore trattamento con DOR/ISL è considerato clinicamente appropriato.
Dati demografici 3. Maschio o femmina di peso corporeo >=35 kg al momento della firma del consenso informato/assenso.
Contraccezione/Gravidanza 1. Una donna può partecipare se non è incinta o non sta allattando e si applica almeno una delle seguenti condizioni: - Non è una WOCBP oppure - E' una WOCBP e sta utilizzando un metodo contraccettivo accettabile, o si astiene da rapporti eterosessuali come stile di vita preferito e abituale (astinenza a lungo termine e persistente), come descritto nell'Appendice 5 durante il periodo di trattamento e per almeno 6 settimane dopo l'ultima dose di trattamento di studio. Lo sperimentatore deve valutare il potenziale fallimento del metodo contraccettivo (cioè, non conforme, iniziato di recente) in relazione alla prima dose dell'intervento in studio. - Una WOCBP deve avere un test di gravidanza altamente sensibile negativo ([urina o siero] come richiesto dalle normative locali) entro 24 ore prima della prima dose dell'intervento in studio - Se un test delle urine non può essere confermato come negativo (ad es. un risultato ambiguo), è necessario un test di gravidanza sul siero. In tali casi, la partecipante deve essere esclusa dalla partecipazione se il risultato della gravidanza nel siero è positivo - Ulteriori requisiti per i test di gravidanza durante e dopo l'intervento dello studio sono indicati nell'Appendice 2 - Lo sperimentatore è responsabile della revisione dell'anamnesi, della storia mestruale e dell'attività sessuale recente per ridurre il rischio di inclusione di una donna con una gravidanza precoce non rilevata - L'uso di contraccettivi da parte delle donne dovrebbe essere coerente con le normative locali relative ai metodi di contraccezione per coloro che partecipano a studi clinici.
Consenso informato/Assenso 4. Il partecipante (o il rappresentante legalmente riconosciuto) ha fornito un consenso informato/assenso documentato per lo studio. |
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E.4 | Principal exclusion criteria |
Concomitant Therapy 1. Is taking or is anticipated to require any prohibited therapies listed in the protocol from 14 days prior to Day 1 through the study treatment period. |
Terapia concomitante 1. Sta assumendo o si prevede che dovrà ricevere una terapia tra quelle vietate elencate nel protocollo da 14 giorni prima del Giorno 1 fino alla fine del periodo di studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of participants with serious adverse events (SAEs) 2. Percentage of participants who discontinued study treatment due to an adverse event (AE) |
1. Percentuale di partecipanti con eventi avversi gravi (SAE) 2. Percentuale di partecipanti che hanno interrotto il trattamento in studio a causa di un evento avverso (EA) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to Week 54 2. Up to Week 48 |
1. Fino alla settimana 54 2. Fino alla settimana 48 |
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E.5.2 | Secondary end point(s) |
Not applicable |
Non applicabile |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Non applicabile |
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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 | No |
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 | No |
E.8.1.1 | Randomised | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Follow Up in aperto |
open-label rollover |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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 |
Australia |
Canada |
Chile |
Colombia |
Israel |
Japan |
Korea, Republic of |
Mexico |
New Zealand |
Peru |
Puerto Rico |
Russian Federation |
South Africa |
Taiwan |
Thailand |
Ukraine |
United States |
Austria |
Finland |
France |
Germany |
Italy |
Poland |
Portugal |
Spain |
Switzerland |
United Kingdom |
Argentina |
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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
|
The overall study ends when the last participant completes the last study-related contact, withdraws consent, or is lost to follow-up (ie, the participant is unable to be contacted by the investigator). |
Lo studio complessivo termina quando l'ultimo partecipante completa l'ultimo contatto correlato allo studio, revoca il consenso o viene perso al follow-up (ad es. il partecipante non può essere contattato dallo sperimentatore). |
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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 | 5 |
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 | 5 |
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 |