Evaluating the Pharmacokinetics, Safety, and Tolerability... | NCT03332095

ID	Type	Description	Link
34150	Registry Identifier	DAIDS-ES Registry Number

Label	Type	Description	Intervention Names
Cohort 1: DOR	Experimental	Participants received a single dose of DOR at study entry (Day 0).	Drug: Doravirine (DOR) Drug: Antiretroviral (ARV) medications
Cohort 2: DOR/3TC/TDF	Experimental	Participants received DOR/3TC/TDF from Day 0 through Week 96.	Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF)

Name	Type	Description	Arm Group Labels	Other Names
Doravirine (DOR)	Drug	100 mg of DOR administered orally	Cohort 1: DOR

Measure	Description	Time Frame
Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)	Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to infinity. Steady state AUC0-24 is equivalent to single dose AUC0-∞.	Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.
PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)	Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA).	Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.
PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)	Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA).	Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug	Percentage and Clopper-Pearson 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs judged by the medical clinic as related to the study drug. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017 (see References).	Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.

Measure	Description	Time Frame
PK Parameter: AUC0-24hr of DOR (Cohort 2)	Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

Name	Affiliation	Role
Ann Melvin, MD, MPH	University of Washington, Seattle Children's Research Institute	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Univ. of Colorado Denver NICHD CRS		Aurora	Colorado	80045	United States
Boston Medical Center Ped. HIV Program NICHD CRS

Label	URL
Link to the IMPAACT 2014 study web page	View source
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017	View source

ID	Title	Description
FG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not provided by the study.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 28, 2021	Jun 2, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to infinity. Steady state AUC0-24 is equivalent to single dose AUC0-∞.

Cohort 1 participants who received the study treatment.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM*hr

Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants	OG0009 OG0010

Title

Denominators

Categories

Title	Measurements
	OG00034.8± 43.2

Primary

PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA).

Cohort 1 participants who received the study treatment.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM

Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Primary

PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA).

Cohort 1 participants who received the study treatment.

Posted

Geometric Mean

Geometric Coefficient of Variation

Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Primary

Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug

Percentage and Clopper-Pearson 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs judged by the medical clinic as related to the study drug. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017 (see References).

Study participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

percentage of participants

Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Primary

Percentage of Participants With Serious Adverse Events (SAEs) Assessed as Related to Study Drug

Percentage and Clopper-Pearson 95% CI of participants with SAEs judged by the medical clinic as related to the study drug. SAEs were reported according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) (see references).

Study participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

percentage of participants

Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Primary

Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug

Percentage and Clopper-Pearson 95% CI of participants with permanent discontinuation of study drug due to AEs judged by the medical clinic as related to the study drug.

Study Participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

percentage of participants

Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Primary

Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug

Percentage and Clopper-Pearson 95% CI of participants with Grade 5 AEs (death) regardless of relationship to study drug.

Study participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

percentage of participants

Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units

Secondary

PK Parameter: AUC0-24hr of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM*hr

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: AUC0-24hr of 3TC (Cohort 2)

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

h.ng/mL

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: AUC0-24hr of Tenofovir (Cohort 2)

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

h.ng/mL

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: Cmax of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

µM

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: Cmax of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: Cmax of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: C24hr of DOR (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: C24hr of 3TC (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

PK Parameter: C24hr of Tenofovir (Cohort 2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2.

The first 10 participants enrolled in Cohort 2.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded.

Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded.

Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 48.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded.

Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded.

Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. One participant whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL was excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded.

Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. Two participants whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 48.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded.

Cohort 2 participants who received at least one dose of study treatment. Participants who discontinued study for reasons other than virologic failure were excluded. Two participant whose sample was diluted due to low volume, resulting in increased assay limit of quantification from 40 to 200 copies/mL were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2)

Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2)

Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 48.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2)

Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured at week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 24 minus at Day 0 are summarized.

Cohort 2 participants who were ART-naive.

Posted

Mean

95% Confidence Interval

Log10 plasma HIV-1 RNA

Measured at Day 0 and week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 48 minus at Day 0 are summarized.

Cohort 2 participants who were ART-naive.

Posted

Mean

95% Confidence Interval

Log10 plasma HIV-1 RNA

Measured at Day 0 and week 48.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)

The differences between log10 HIV RNA at Week 96 minus at Day 0 are summarized.

Cohort 2 participants who were ART-naive.

Posted

Mean

95% Confidence Interval

Log10 plasma HIV-1 RNA

Measured at Day 0 and week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2)

The mean difference is calculated as CD4 count at Week 24 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI.

Cohort 2 participants who had non-missing values at both Day 0 and Week 24 timepoints.

Posted

Mean

95% Confidence Interval

cells/mm^3

Measured at Day 0 and week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2)

The mean differences is calculated as CD4 count at Week 48 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI.

Cohort 2 participants who had non-missing values at both Day 0 and Week 48 timepoints.

Posted

Mean

95% Confidence Interval

cells/mm^3

Measured at Day 0 and week 48.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2)

The mean difference is calculated as CD4 count at Week 96 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI.

Cohort 2 participants who had non-missing values at both Day 0 and Week 96 timepoints.

Posted

Mean

95% Confidence Interval

cells/mm^3

Measured at Day 0 and week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2)

The mean difference is calculated as CD4% at Week 24 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI.

Cohort 2 participants who had non-missing values at both Day 0 and Week 24 timepoints.

Posted

Mean

95% Confidence Interval

Percent of total lymphocytes

Measured at Day 0 and week 24.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2)

The mean difference is calculated as CD4% at Week 48 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI.

Cohort 2 participants who had non-missing values at both Day 0 and Week 48 timepoints.

Posted

Mean

95% Confidence Interval

Percent of total lymphocytes

Measured at Day 0 and week 48.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2)

The mean difference is calculated as CD4% at Week 96 minus CD4% at the Day 0 with associated 95% Clopper-Pearson CI.

Cohort 2 participants who had non-missing values at both Day 0 and Week 96 timepoints.

Posted

Mean

95% Confidence Interval

Percent of total lymphocytes

Measured at Day 0 and week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts
Participants

Secondary

Percentage of Participants With Grade 3 or Higher Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study

Percentage and Clopper-Pearson 95% CI of participants with Grade 3 or higher AEs judged by the medical clinic as related to the study drug. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017 (DAIDS) AE Grading table corrected version 2.1 (see References).

Study participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured from Day 0 through Week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Serious Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study

Percentage and Clopper-Pearson 95% CI of participants with SAEs judged by the medical clinic as related to the study drug. SAEs were reported according to version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual) (see references).

Study participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured from Day 0 through Week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study

Percentage and Clopper-Pearson 95% CI of participants with permanent discontinuation of study drug due to AEs judged by the medical clinic as related to the study drug.

Study Participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

Percentage of participants

Measured from Day 0 through Week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Secondary

Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study

Percentage and Clopper-Pearson 95% CI of participants with Grade 5 adverse events (death).

Study participants who received at least one dose of study treatment were included.

Posted

Number

95% Confidence Interval

percentage of participants

Measured from Day 0 through Week 96.

ID	Title	Description
OG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
OG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Conjunctival pallor	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Dental caries	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected9 at risk EG0016 affected45 at risk
Flatulence	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Hyperaesthesia teeth	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Loose tooth	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Salivary gland mucocoele	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Face oedema	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Injection site pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Malaise	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Bronchitis viral	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Hordeolum	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0014 affected45 at risk
Pharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Purulent discharge	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Tonsillitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Urethritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Urethritis gonococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Adverse event following immunisation	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0015 affected45 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG00121 affected45 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 affected9 at risk EG00115 affected45 at risk
Blood albumin decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected9 at risk EG00114 affected45 at risk
Blood bicarbonate decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG00112 affected45 at risk
Blood bilirubin increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Blood cholesterol increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0017 affected45 at risk
Blood creatinine increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG00121 affected45 at risk
Blood glucose decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0016 affected45 at risk
Blood glucose increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected9 at risk EG0018 affected45 at risk
Blood phosphorus decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0014 affected45 at risk
Blood phosphorus increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected45 at risk
Blood potassium decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0019 affected45 at risk
Blood potassium increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Blood pressure increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0018 affected45 at risk
Blood sodium decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0017 affected45 at risk
Blood triglycerides increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Carbon dioxide decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG00111 affected45 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG00125 affected45 at risk
Haemoglobin decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0017 affected45 at risk
Lipase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0018 affected45 at risk
Low density lipoprotein increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Neutrophil count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 affected9 at risk EG0013 affected45 at risk
Platelet count decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Hypocholesterolaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0014 affected45 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Bone callus excessive	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Anosmia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0019 affected45 at risk
Lethargy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Anembryonic gestation	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Tension	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Dysuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Glycosuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Proteinuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0016 affected45 at risk
Urethral discharge	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Bleeding anovulatory	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Oligomenorrhoea	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Penile swelling	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Scrotal pain	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Scrotal swelling	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0019 affected45 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0016 affected45 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0015 affected45 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0015 affected45 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0018 affected45 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Acanthosis nigricans	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0014 affected45 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0013 affected45 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0014 affected45 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected45 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected45 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
C000592662	doravirine
D044966	Anti-Retroviral Agents
D004304	Dosage Forms

ID	Term
D000998	Antiviral Agents
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004364	Pharmaceutical Preparations
D013678	Technology, Pharmaceutical
D008919	Investigative Techniques

ID	Title	Description
BG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.
BG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: DOR	Participants received a single dose of DOR at study entry (Day 0). Doravirine (DOR): 100 mg of DOR administered orally Antiretroviral (ARV) medications: Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not be provided by the study.	0	9	0	9	4	9
EG001	Cohort 2: DOR/3TC/TDF	Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily.	0	45	2	45	45	45