Effects of Losartan and Antiretroviral Regimen Containing... | NCT01529749

NCT01529749

ID	Type	Description	Link
2011-002071-42	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
EFV/FTC/TDF	Active Comparator	Drug: EFV/FTC/TDF
EFV/FTC/TDF + Losartan	Experimental	Drug: EFV/FTC/TDF + Losartan
FTC/TDF + MK-0518	Experimental	Drug: FTC/TDF + MK-0518
FTC/TDF+MK-0518+Losartan	Experimental	Drug: FTC/TDF+MK-0518+Losartan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EFV/FTC/TDF + Losartan	Drug	EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.

Outcomes Module

Measure	Description	Time Frame
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.		48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.		48 weeks
Proportion of Patients With Changes in the Levels of CRP in Different Groups.		48 weeks

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic		Barcelona		08036	Spain

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
FG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

EFV/FTC/TDF + Losartan

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
BG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
BG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
BG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG00110 BG00210 BG00310 BG00442

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG00040(33 to 48) BG00143(35 to 49) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0012 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Spain

Title	Measurements
	BG00012 BG00110 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

Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.

Eligibility criteria were being older than 18 years, being on ART with a combined triple therapy regimen and having viral load under the limit of detection for at least the previous 48 weeks.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts
Participants	OG00012 OG00110 OG00210 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

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 OG002 OG003		Chi-squared, Corrected		1														Superiority

Secondary

Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Changes in the Levels of CRP in Different Groups.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Increased CD4 in Peripheral Blood.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Increased CD4 in Lymphatic Tissue.

Posted

Number

participants

week 48

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Undetectable Plasma Viral Load in Different Groups

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups

Posted

Number

participants

week 48

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.

Posted

Median

Inter-Quartile Range

ratio

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.

Carotid ultrasound was performed at baseline in 41 out the 42 patients. However, only 36 patients repeated the ultrasound at week 48, and were included in the analysis (9 in each randomised group).

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Secondary

Proportion of Patients With Changes in Levels of Metalloproteinases

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Changes in Levels of beta2-microglobulin.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Changes in Levels of CSF Cells.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Changes in Levels of Proteins.

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Proportion of Patients With Improvement in Neuropsychological Test

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.

Posted

Number

participants

up to 48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Units	Counts

Secondary

Changes in CD4 CD38+ HLADR+ (%)

Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline)

Posted

Median

Inter-Quartile Range

percentage of CD4 T cells

0, 48 weeks

ID	Title	Description
OG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral
OG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
OG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
OG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	EFV/FTC/TDF	EFV/FTC/TDF: 600/200/245 mg, od, oral	12	12	6	12
EG001	EFV/FTC/TDF + Losartan	EFV/FTC/TDF + Losartan: EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.	10	10	6	10
EG002	FTC/TDF + MK-0518	FTC/TDF + MK-0518: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral	10	10	3	10
EG003	FTC/TDF+MK-0518+Losartan	FTC/TDF+MK-0518+Losartan: FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.	10	10	6	10

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Post lumbar puncture headache	Nervous system disorders	Systematic Assessment	Post lumbar puncture headache	EG0001 events1 affected12 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk EG0031 events1 affected10 at risk
Hepatitis C	Infections and infestations	Systematic Assessment		EG0000 events0 affected12 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected12 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk EG003
High Blood Pressure	Vascular disorders	Systematic Assessment		EG0000 events0 affected12 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk EG003
Tendinitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment		EG0001 events1 affected12 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk EG003
Liver tests abonormalities	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected12 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk EG003
Sexual transmitted diseases	Infections and infestations	Systematic Assessment		EG0001 events1 affected12 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk EG003
Asthenia	Psychiatric disorders	Non-systematic Assessment		EG0000 events0 affected12 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk EG003
Gynecomastia	Endocrine disorders	Non-systematic Assessment		EG0001 events1 affected12 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk EG003
Dysthimia	Psychiatric disorders	Non-systematic Assessment		EG0001 events1 affected12 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk EG003
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected12 at risk EG0011 events1 affected10 at risk EG0020 events0 affected10 at risk EG003
Insomnia	Psychiatric disorders	Non-systematic Assessment		EG0000 events0 affected12 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk EG003
Headache	Nervous system disorders	Non-systematic Assessment		EG0000 events0 affected12 at risk EG0010 events0 affected10 at risk EG0021 events1 affected10 at risk EG003
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected12 at risk EG0010 events0 affected10 at risk EG0020 events0 affected10 at risk EG003

ID	Term
D019808	Losartan
D000068898	Raltegravir Potassium

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles
D011760	Pyrrolidinones
D011759	Pyrrolidines

Units	Counts
Participants	OG00012 OG00110 OG00210 OG00310