Safety and Efficacy of Switching From Dolutegravir and AB... | NCT02603120

ID	Type	Description	Link
2015-004025-14	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blinded Phase: B/F/TAF	Experimental	B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks	Drug: B/F/TAF Drug: ABC/DTG/3TC Placebo
Blinded Phase: ABC/DTG/3TC	Active Comparator	ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks	Drug: ABC/DTG/3TC Drug: B/F/TAF Placebo
Open-Label Phase	Experimental	At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.	Drug: B/F/TAF

Name	Type	Description	Arm Group Labels	Other Names
ABC/DTG/3TC	Drug	600/50/300 mg FDC tablets administered orally once daily without regard to food	Blinded Phase: ABC/DTG/3TC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31430369	Result	Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347.
29925489

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	B/F/TAF	Double-Blind Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) tablet + abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) placebo orally once daily for at least 48 weeks, without regard to food. Open-label (OL) Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Original	Oct 21, 2015	Aug 24, 2018

Arm/Group Information

ID	Title	Description
BG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
BG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046± 11.1 BG00145± 11.5 BG00245± 11.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00035 BG00129 BG002

Race/Ethnicity, Customized

Not Permitted = local regulators did not allow collection of race or ethnicity information.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0012

Race/Ethnicity, Customized

Not Permitted = local regulators did not allow collection of race or ethnicity information

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00046 BG00152 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG00013 BG00122 BG002

HIV-1 RNA Categories

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 50 copies/mL	BG000278 BG001272 BG002

CD4 Cell Count

Mean

Standard Deviation

cell/µL

Title

Denominators

Categories

Title	Measurements
	BG000752± 302.2 BG001694± 291.6 BG002

CD4 Cell Count Category

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
≥ 50 to < 200 cells/μL	BG0006 BG0014 BG002

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

Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

The Full Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
OG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Units	Counts
Participants	OG000282 OG001281

Title

Denominators

Categories

Title	Measurements
	OG0001.1 OG0010.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in Percentages	0.7			2-Sided	95.002	-1.0	2.8			The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.		Non-Inferiority	A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Participants in the Full Analysis were analyzed.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
OG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Secondary

Change From Baseline in CD4+ Cell Count at Week 48

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

cells/µL

Baseline; Week 48

ID	Title	Description
OG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
OG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Units	Counts
Participants	OG000

Secondary

Spine Bone Mineral Density (BMD) at Baseline

The Spine dual X-ray absorptiometry (DXA) analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.

Posted

Mean

Standard Deviation

g/cm^2

Baseline

ID	Title	Description
OG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
OG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Units	Counts
Participants

Secondary

Percentage Change From Baseline in Spine BMD at Week 48

Participants in the Spine DXA Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

percentage change

Baseline; Week 48

ID	Title	Description
OG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
OG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Units	Counts
Participants

Secondary

Hip Bone Mineral Density at Baseline

The Hip DXA Analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.

Posted

Mean

Standard Deviation

g/cm^2

Baseline

ID	Title	Description
OG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
OG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Units	Counts
Participants

Secondary

Percentage Change From Baseline in Hip BMD at Week 48

Participants in the Hip DXA Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

percentage change

Baseline; Week 48

ID	Title	Description
OG000	B/F/TAF	Double-Blind Phase: B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
OG001	ABC/DTG/3TC	Double-Blind Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. OL Extension Phase: After Week 48, participants in a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-Blind: B/F/TAF	B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.	2	282	17	282	122	282
EG001	Double-Blind: ABC/DTG/3TC	ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.	0	281	26	281	132	281
EG002	Open-label Extension: B/F/TAF From B/F/TAF	Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	1	259	24	259	84	259
EG003	Open-label Extension: B/F/TAF From ABC/DTG/3TC	Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	1	265	11	265	82	265

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG0031 affected265 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected281 at risk EG0020 affected259 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Myocardial bridging	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Macular detachment	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Retinal detachment	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Sudden cardiac death	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Abscess limb	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0012 affected281 at risk EG0020 affected259 at risk EG003
Acute hepatitis C	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Anal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Appendicitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0021 affected259 at risk EG003
Cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Cellulitis of male external genital organ	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Endocarditis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Escherichia infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Eye infection syphilitic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Influenza	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Large intestine infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Lymphadenitis bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Post procedural sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Shigella infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0021 affected259 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Wound infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Malignant neoplasm of thymus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Testicular seminoma (pure) stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Hemiplegic migraine	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Alcohol abuse	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Paranoia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Self-injurious ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Substance abuse	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0011 affected281 at risk EG0020 affected259 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0021 affected259 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected282 at risk EG0010 affected281 at risk EG0020 affected259 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00026 affected282 at risk EG00118 affected281 at risk EG00220 affected259 at risk EG00311 affected265 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0006 affected282 at risk EG00116 affected281 at risk EG0023 affected259 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00011 affected282 at risk EG00115 affected281 at risk EG00211 affected259 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00021 affected282 at risk EG00122 affected281 at risk EG00220 affected259 at risk EG003
Sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00011 affected282 at risk EG00115 affected281 at risk EG0029 affected259 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00034 affected282 at risk EG00132 affected281 at risk EG00222 affected259 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00021 affected282 at risk EG00118 affected281 at risk EG0028 affected259 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00013 affected282 at risk EG00113 affected281 at risk EG00213 affected259 at risk EG003
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00019 affected282 at risk EG00123 affected281 at risk EG0025 affected259 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0009 affected282 at risk EG00122 affected281 at risk EG0021 affected259 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85012	United States

ID	Term
C000631408	abacavir, dolutegravir, and lamivudine drug combination
C000620396	bictegravir
C442442	tenofovir alafenamide
C000654125	bictegravir, emtricitabine, tenofovir alafenamide, drug combination