Changes in Triglyceride and Other Lipids (Levels of Fats... | NCT00757783

ID	Type	Description	Link
TMC114HIV4023	Other Identifier	Tibotec, Inc.

Status Module

Name	Class
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA	INDUSTRY

Description Module

Detailed Description

The purpose of this study is to expand our understanding of the metabolic effects of darunavir/ritonavir (DRV/r) in HIV-infected patients. This is a phase 4, multicenter, open-label, randomized (study drug assigned by chance), comparative study designed to compare changes in lipid, glucose, and insulin parameters in HIV-infected, anti-retroviral (ARV) naive patients treated with DRV/r 800/100 mg once daily (QD) versus atazanavir/ritonavir (ATV/r) 300/100 mg QD in combination with a common background of emtricitabine (FTC)/ tenofovir (TDF) 200/300 mg QD. In addition, changes in inflammatory markers will be measured. A substudy of the parent study TMC114HIV4023 will evaluate insulin sensitivity and endothelial function in a subset of patients. The study will be conducted at approximately 16 study sites in the United States. Approximately 60 HIV-1 infected, treatment-naive adult patients will be enrolled in the study. Screening will take place during a 4-week period. At the baseline visit, eligible patients will be randomized in a 1:1 ratio to receive DRV/r 800/100 mg QD or ATV/r 300/100 mg QD administered in combination with a fixed-dose background regimen consisting of emtricitabine (FTC)/tenofovir (TDF) 200/300 mg once daily. The treatment period is 48 weeks. Study assessments will be performed at clinic visits at the end of weeks 4, 8, 12, 24, 36, and 48. The primary endpoint will be assessed at week 12. All patients will return for follow up visits 1 week and 4 weeks after the completion of study treatment. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Up to twenty patients (evenly randomized to receive DRV/r or ATV/r) who meet additional entry criteria will be enrolled in the substudy. The study hypothesis is the change in triglycerides and other lipids from baseline to week 12 will be similar in the DRV/r arm versus the ATV/r arm. The substudy hypothesis is that DRV/r will not adversely affect insulin sensitivity or endothelial function during 12 weeks of therapy, and the change from baseline in insulin sensitivity and endothelial function will be similar in the DRV/r arm versus the ATV/r arm. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Patients will be randomized in a 1:1 ratio to receive darunavir/ritonavir 800/100 mg once daily (QD) plus emtricitabine (FTC)/tenofovir (TDF) 200/300 mg QD or atazanavir/ritonavir 300/100 mg QD plus emtricitabine (FTC)/tenofovir (TDF) for 48 weeks.

Label	Type	Description	Intervention Names
darunavir	Experimental	darunavir 800 mg tablet once daily for 48 weeks,emtricitabine [FTC]/tenofovir [TDF] 200/300 mg tablet once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks	Drug: ritonavir Drug: darunavir Drug: emtricitabine [FTC]/tenofovir [TDF]
atazanavir	Experimental	atazanavir 300 mg capsule once daily for 48 weeks,emtricitabine [FTC]/tenofovir [TDF] 200/300 mg once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks	Drug: ritonavir Drug: emtricitabine [FTC]/tenofovir [TDF] Drug: atazanavir

Name	Type	Description	Arm Group Labels	Other Names
ritonavir	Drug	100 mg capsule or tablet once daily for 48 weeks	darunavir

Measure	Description	Time Frame
Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12	Observed values.	Baseline, Week 12

Measure	Description	Time Frame
Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48	Observed Values	Baseline, Week 12 and 48
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.

Eligibility Module

Name	Affiliation	Role
Tibotec, Inc. Clinical Trial	Tibotec, Inc	Study Director

PubMed Identifier	Type	Citation	Retractions
26917112	Derived	Overton ET, Tebas P, Coate B, Ryan R, Perniciaro A, Dayaram YK, De La Rosa G, Baugh BP. Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial. HIV Clin Trials. 2016 Mar;17(2):72-7. doi: 10.1080/15284336.2016.1141468.
21470045

ID	Title	Description
FG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
FG001	Atazanavir

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

Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12

Observed values.

The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Posted

Mean

Standard Deviation

milligram per deciliters (mg/dL)

Baseline, Week 12

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants	OG00028 OG00127

Title

Denominators

Categories

Baseline (n=28,27)

Title	Measurements
	OG000113.7± 57.40 OG001114.2± 84.05

Change at Week 12 (n=27,27)

Title	Measurements
	OG000

Secondary

Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48

Observed Values

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.

Observed Values

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.

Observed Values

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.

Observed Values

Posted

Mean

Standard Deviation

grams per liters (g/L)

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.

Observed Values

Posted

Mean

Standard Deviation

g/L

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.

Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.

Posted

Mean

Standard Deviation

ratio

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Glucose at Week 12 and 48.

Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.

Intent-to-treat (ITT) population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. 'N'=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Insulin at Week 12 and 48.

Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.

The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. 'N'=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.

Posted

Mean

Standard Deviation

IU/mL

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.

Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).

Posted

Mean

Standard Deviation

HOMA-IR score

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Secondary

Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.

Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.

The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.

Posted

Number

number of participants

Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)

Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.

The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.

Posted

Number

number of participants

Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.

the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.

The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Posted

Mean

Standard Deviation

Log10 HIV RNA

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.

Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.

The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Posted

Mean

Standard Deviation

cells/micro L

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts
Participants

Secondary

Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).

Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.

The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Posted

Mean

Standard Deviation

cells/uL

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts

Secondary

Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).

Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.

The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Posted

Mean

Standard Deviation

percentage of CD4 cells

Baseline, Week 12 and 48

ID	Title	Description
OG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
OG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Mitral Valve Incompetence	Cardiac disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected29 at risk
Chest Pain	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk
Immune Reconstitution Syndrome	Immune system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected29 at risk
Bacteraemia	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk
Pneumonia	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk
Fracture of Penis	Injury, poisoning and procedural complications	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected29 at risk
Pneumonitis Chemical	Injury, poisoning and procedural complications	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk
Blood Glucose Increased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected29 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected29 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected29 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected29 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected29 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected29 at risk
Ocular Icterus	Eye disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0015 affected29 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0003 affected31 at risk EG0012 affected29 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected29 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00010 affected31 at risk EG0015 affected29 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected29 at risk
Flatulence	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected29 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0008 affected31 at risk EG0012 affected29 at risk
Fatigue	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0004 affected31 at risk EG0013 affected29 at risk
Pain	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk
Pyrexia	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0004 affected31 at risk EG0011 affected29 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0014 affected29 at risk
Jaundice	Hepatobiliary disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0013 affected29 at risk
Immune Reconstitution Syndrome	Immune system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0003 affected31 at risk EG0010 affected29 at risk
Seasonal Allergy	Immune system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected29 at risk
Folliculitis	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected29 at risk
Furuncle	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected29 at risk
Influenza	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk
Oral Herpes	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected29 at risk
Tinea Pedis	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected29 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected29 at risk
Blood Bilirubin Increased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG00110 affected29 at risk
Blood Cholesterol Increased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected29 at risk
Low Density Lipoprotein Increased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0004 affected31 at risk EG0013 affected29 at risk
Neutrophil Count Decreased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected29 at risk
Weight Decreased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected29 at risk
Dizziness	Nervous system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected29 at risk
Headache	Nervous system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected29 at risk
Depression	Psychiatric disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0016 affected29 at risk
Insomnia	Psychiatric disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected29 at risk
Pollakiuria	Renal and urinary disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected29 at risk
Penile Discharge	Reproductive system and breast disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0005 affected31 at risk EG0010 affected29 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected29 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected29 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected29 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California		United States

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D015658	HIV Infections

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
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D019438	Ritonavir
D000069454	Darunavir
D000068679	Emtricitabine
D000069446	Atazanavir Sulfate

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013449	Sulfonamides
D000577	Amides
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D013450	Sulfones
D005663	Furans
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D011725	Pyridines
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description
BG000	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
BG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
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	Darunavir	Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.			5	31	28	31
EG001	Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks			5	29	25	29