E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 infection |
Infección por VIH |
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E.1.1.1 | Medical condition in easily understood language |
HIV-1 infection |
Infección por VIH |
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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. Evaluar la seguridad y la tolerabilidad de doravirina/ islatravir (DOR/ISL), según los datos de seguridad acumulados hasta la semana 48. |
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E.2.2 | Secondary objectives of the trial |
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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 4. 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 5. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. |
Tipo de participante y características de la enfermedad 1. Estar recibiendo actualmente la CDF de DOR/ISL en comprimidos para adultos en un estudio clínico patrocinado por Merck y haber completado la última visita de tratamiento. 2. El investigador considera que ha obtenido beneficios clínicos del tratamiento con DOR/ISL y que es clínicamente adecuado que continúe el tratamiento con DOR/ISL. Datos demográficos 3. Varón o mujer con un peso ≥35 kg en el momento de firmar el consentimiento/asentimiento informado. Anticoncepción/embarazo 4. Podrán participar mujeres que no estén embarazadas ni en período de lactancia y que cumplan al menos una de las condiciones siguientes: • No está en edad fértil. O • Es una mujer en edad fértil (MEF) y utiliza un método anticonceptivo aceptable o practica la abstinencia de relaciones heterosexuales como modo de vida preferido y habitual (abstinencia a largo plazo y persistente), según se describe en el apéndice 5, durante el período de intervención y durante, como mínimo, 6 semanas después de recibir la última dosis de la intervención del estudio. El investigador deberá evaluar la posibilidad de fracaso del método anticonceptivo (es decir, incumplimiento o inicio reciente) en relación con la primera dosis de la intervención del estudio. - Las mujeres en edad fértil (MEF) deberán dar negativo en una prueba de embarazo de alta sensibilidad ([en orina o suero], según exija la normativa local) en las 24 horas previas a la primera dosis de la intervención del estudio. - Cuando no pueda confirmarse que el resultado de una prueba en orina es negativo (por ejemplo, resultado ambiguo), será necesario hacer una prueba de embarazo en suero. En tales casos, la posible participante será excluida si el resultado de la prueba de embarazo en suero es positivo. - En el apéndice 2 se recogen otros requisitos relacionados con las pruebas de embarazo durante y después de la intervención del estudio. - El investigador es responsable de revisar los antecedentes médicos, los antecedentes menstruales y la actividad sexual reciente para reducir el riesgo de incluir a una mujer con un embarazo de poco tiempo no detectado. - El uso de anticonceptivos por las mujeres deberá cumplir la normativa local sobre métodos anticonceptivos para participantes en estudios clínicos. Consentimiento/asentimiento informado 5. El participante (o su representante legal) ha otorgado su consentimiento/asentimiento informado documentado para el estudio. |
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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. |
Tratamiento concomitante 1. Está recibiendo o se espera que necesite alguno de los tratamientos no permitidos que se describen en el protocolo desde 14 días antes del día 1 y durante todo el período de tratamiento del estudio. |
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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. Porcentaje de participantes con eventos adversos graves (AAGs) 2. Porcentaje de participantes que interrumpieron el tratamiento del estudio debido a un evento adverso (AA) |
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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. Hasta la semana 54 2. Hasta la semana 48 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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) | 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 | 7 |
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 | No |
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
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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). |
El estudio general finaliza cuando el último participante completa el último contacto relacionado con el estudio, retira el consentimiento o se pierde durante el seguimiento (es decir, el investigador no puede contactar al participante). |
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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 |