Clinical Trials Register

Summary
EudraCT Number:	2019-000588-26
Sponsor's Protocol Code Number:	MK-8591A-019
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-02-19
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2019-000588-26

A.3

Full title of the trial

A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Doravirine/Islatravir in heavily treatment-experienced participants

A.3.2

Name or abbreviated title of the trial where available

DOR/ISL in heavily treatment-experienced participants

A.4.1

Sponsor's protocol code number

MK-8591A-019

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04199104

A.5.4

Other Identifiers

Name:

IND

Number:

134,036

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck Sharp & Dohme LLC
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merck Sharp & Dohme LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme LLC
B.5.2	Functional name of contact point	Global Clinical Trial Organization
B.5.3	Address:
B.5.3.1	Street Address	126 East Lincoln Ave., P.O. Box 2000
B.5.3.2	Town/ city	Rahway, NJ
B.5.3.3	Post code	07065
B.5.3.4	Country	Germany
B.5.4	Telephone number	+17325943736
B.5.6	E-mail	wayne.greaves@merck.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Doravirine (Pifeltro)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme BV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DORAVIRINE
D.3.9.2	Current sponsor code	MK-1439
D.3.9.4	EV Substance Code	SUB177834
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Doravirine
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Corp.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DORAVIRINE
D.3.9.2	Current sponsor code	MK-1439
D.3.9.4	EV Substance Code	SUB177834
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Doravirine
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Corp.
D.2.1.2	Country which granted the Marketing Authorisation	Canada
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DORAVIRINE
D.3.9.2	Current sponsor code	MK-1439
D.3.9.4	EV Substance Code	SUB177834
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Islatravir
D.3.2	Product code	MK-8591
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MK-8591
D.3.9.3	Other descriptive name	MK-8591
D.3.9.4	EV Substance Code	SUB130009
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Doravirine/Islatravir
D.3.2	Product code	MK-8591A
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DORAVIRINE
D.3.9.2	Current sponsor code	MK-1439
D.3.9.4	EV Substance Code	SUB177834
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MK-8591
D.3.9.3	Other descriptive name	MK-8591
D.3.9.4	EV Substance Code	SUB130009
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

HIV-1 infection

E.1.1.1

Medical condition in easily understood language

HIV-1 infection

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

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1.To evaluate the antiretroviral activity of doravirine/islatravir (DOR/ISL) compared to placebo, each given in combination with failing antiretroviral therapy (ART) as assessed by the percentage of
participants achieving ≥0.5 log10 decrease in HIV-1 RNA from study baseline (Day 1) to Day 8 (Part 1)
2.2.To evaluate the safety and tolerability of DOR/ISL as assessed by review of the accumulated safety data through Week 25 and Week 49.

E.2.2

Secondary objectives of the trial

1.To evaluate the safety and tolerability of DOR/ISL through Week 97
2.To assess antiretroviral activity of DOR, ISL+failing antiretroviral therapy (ART) based on % of participants with ≥0.5 and ≥1.0 log10 decrease in HIV-1 RNA
3.To assess antiretroviral activity of DOR, ISL + failing ART based on % of participants with ≥0.5 log10 decrease in HIV-1 RNA; mean change in HIV-1 RNA; and % of participants with ≥1.0 log10 decrease in HIV-1 RNA
4.To assess antiretroviral activity of DOR, ISL, optimized background therapy (OBT) based on % of participants achieving ≥0.5 log10 and ≥1.0 log10 decrease in HIV-1 RNA; mean change in HIV-1 RNA; % of participants with HIV-1 RNA <50 and <200 copies/mL; and % of participants with HIV-1 RNA <40 copies/mL
5.To assess development of viral drug resistance to DOR, ISL, OBT
6.To assess the role of baseline antiviral resistance on virologic outcomes
7.To assess the change in CD4+ T-cell counts

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Is HIV-1 positive with plasma HIV-1 RNA ≥ 500 copies/mL at the Screening Visit and confirmed upon repeat testing (Visit 2 [or Visit 3 if required]) during the Run-in period.
In addition, the log change in HIV-1 RNA must meet 1 of the following criteria at a confirmation visit:
- < 0.5 log10 decline in HIV-1 RNA from the Screening Visit (Visit 1) to the Confirmation visit (Visit 2)
OR
- If ≥ 0.5 log10 decline in HIV-1 RNA at Visit 2, another confirmation test is required (Visit 3). In this case, there must be < 0.3 log10 decline in HIV-1 RNA from Visit 2
2. Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form.
3. Has at least triple-class resistance (NRTI, NNRTI, and resistance to at least 1 other class [ie, resistance to at least 1 drug in each class]) based on resistance testing at the Screening Visit.
4. Has ≤1 fully active antiretroviral drugs remaining, among all antiretroviral classes, that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or
acceptability to participant.
5. Is male or female, adult (≥18 years of age) or pediatric participants (weighing ≥35 kg, and <18 years of age), at the time of signing the informed consent/assent (the Screening Visit).
6. 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 woman of childbearing potential (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), during the intervention period and for at least 6 weeks, corresponding to the time needed to eliminate any study intervention(s) (eg, 5 terminal half-lives) 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.
- 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.
7. The participant (or legally acceptable representative) has provided documented written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical
research. However, the participant may participate in the main study without participating in future biomedical research.

E.4

Principal exclusion criteria

1. Has HIV-2 infection.
2. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
3. Has HBV co-infection (defined as HBsAg-positive or HBV DNA positive) and is not currently being treated for HBV.
4. Has a history or current evidence of any condition (including active TB co-infection), therapy, laboratory abnormality, or other circumstance
(including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere
with study participation for the full study duration.
5. Is taking or is anticipated to require any of the prohibited therapies from the Screening Visit and throughout the study treatment period.
6. Is taking DOR as part of his/her current failing antiretroviral regimen.
7. Is taking EFV, etravirine, or nevirapine.
8. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period.
9. Has exclusionary laboratory values (based on central laboratory results) at the Screening Visit
10. Is female and is expecting to conceive or donate eggs at any time during the study.

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of participants receiving DOR/ISL with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to placebo treatment
2. Percentage of participants with ≥1 adverse events (AEs)
3. Percentage of participants withdrawing from study treatment due to AE(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Day 1 (baseline) to Day 8
2. Up to 49 weeks
3. Up to 49 weeks

E.5.2

Secondary end point(s)

1.Percentage of participants with ≥1 adverse events (AEs)
2.Percentage of participants withdrawing from study therapy due to AEs
3.Percentage of participants receiving DOR or ISL (given with ART) with ≥0.5 log10 decrease in HIV-1 RNA compared to placebo treatment
4.Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) , DOR, or ISL compared to placebo treatment
5.Percentage of participants receiving DOR/ISL (given with ART), DOR, or ISL with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to placebo treatment
6.Percentage of participants receiving DOR/ISL (given with ART) with ≥ 0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
7.Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment
8.Percentage of participants receiving DOR/ISL (given with ART) with ≥ 1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
9.Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
10.Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
11.Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
12.Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
13.Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
14.Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment
15.Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
16.Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
17.Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
18.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL
19.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL
20.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL
21.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL
22.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL
23.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL
24.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL
25.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL
26.Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL
27.Prevalence of viral drug resistance to DOR
28.Prevalence of viral drug resistance to DOR
29.Prevalence of viral drug resistance to ISL
30.Prevalence of viral drug resistance to ISL
31.Prevalence of viral drug resistance to OBT components
32.Prevalence of viral drug resistance to OBT components
33.Role of baseline antiviral resistance on viral resistance-associated substitutions (RAS)
34.Role of baseline antiviral resistance on viral RAS
35.Role of baseline antiviral resistance on viral RAS
36.Role of baseline antiviral resistance on HIV-1 RNA
37.Role of baseline antiviral resistance on HIV-1 RNA
38.Role of baseline antiviral resistance on HIV-1 RNA
39.Change from baseline in cluster of differentiation+ (CD4+) cell counts
40.Change from baseline in CD4+ cell counts
41.Change from baseline in CD4+ cell counts
42.Change from baseline in CD4+ cell counts
43.Change from baseline in CD4+ cell counts
44.Change from baseline in CD4+ cell counts

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Up to 97 wks
2.Up to 97 wks
3.D 1(BL) to D 8
4.D 1(BL) to D 8
5.D 1(BL) to D 8
6.D 1(BL) to D 8
7.D 1(BL) to D 8
8.D 1(BL) to D 8
9.D 8(BL) to W 25
10.D 1(BL) to W 49
11.D 1(BL) to W 97
12.D 8(BL) to W 25
13.D 1(BL) to W 49
14.D 1(BL) to W 97
15.D 8(BL) to W 25
16.D 1(BL) to W 49
17.D 1(BL) to W 97
18.D 8(BL) to W 25
19.D 1(BL) to W 49
20.D 1(BL) to W 97
21.D 8(BL) to W 25
22.D 1(BL) to W 49
23.D 1(BL) to W 97
24.D 8(BL) to W 25
25.D 1(BL) to W 49
26.D 1(BL) to W 97
27.W 25
28.W 49
29.W 25
30.W 49
31.W 25
32.W 49
33.D 1(BL) to W 25
34.D 1(BL) to W 49
35.D 1(BL) to W 97
36.D 1(BL) to W 25
37.D 1(BL) to W 49
38.D 1(BL) to W 97
39.D 1(BL) to W 25
40.D 1(BL) to W 49
41.D 1(BL) to W 97
42.D 8(BL) to W 25
43.D 8(BL) to W 49
44.D 8(BL) to W 97

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Open single group in Part 2

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Japan

Korea, Republic of

Mexico

Peru

South Africa

United States

France

Spain

Germany

Italy

Portugal

Russian Federation

Ukraine

United Kingdom

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

110

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

At the end of Week 97, provided development of DOR/ISL continues, all eligible participants will be given the option to continue receiving study
intervention without interruption. Eligible participants are those who have completed the last scheduled study visit and are considered by the investigator to derive clinical benefit from continued administration of DOR/ISL.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-11-01

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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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