Trial Outcomes & Findings for Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated (NCT NCT01529749)
NCT ID: NCT01529749
Last Updated: 2019-08-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
48 weeks
Results posted on
2019-08-02
Participant Flow
Participant milestones
| Measure |
EFV/FTC/TDF
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
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.
|
FTC/TDF + MK-0518
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
EFV/FTC/TDF
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
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.
|
FTC/TDF + MK-0518
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
Baseline characteristics by cohort
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
40 years
n=5 Participants
|
43 years
n=7 Participants
|
43 years
n=5 Participants
|
35 years
n=4 Participants
|
41 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
42 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: 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.
Outcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Changes in the Levels of CRP in Different Groups.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Increased CD4 in Peripheral Blood.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: week 48Outcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Increased CD4 in Lymphatic Tissue.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
|
12 participants
|
10 participants
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: week 48Outcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
|
12 participants
|
10 participants
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
|
-0.03 ratio
Interval -0.2 to 0.3
|
0.04 ratio
Interval -0.2 to 0.3
|
0.36 ratio
Interval 0.0 to 0.5
|
0.37 ratio
Interval 0.2 to 0.6
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: 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).
Outcome measures
| Measure |
EFV/FTC/TDF
n=9 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=9 Participants
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.
|
FTC/TDF + MK-0518
n=9 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=9 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Changes in Levels of Metalloproteinases
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Changes in Levels of beta2-microglobulin.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Changes in Levels of CSF Cells.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Changes in Levels of Proteins.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Proportion of Patients With Improvement in Neuropsychological Test
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 48 weeksOutcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
|
6 participants
|
6 participants
|
3 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 0, 48 weeksMarker 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)
Outcome measures
| Measure |
EFV/FTC/TDF
n=12 Participants
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 Participants
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.
|
FTC/TDF + MK-0518
n=10 Participants
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 Participants
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.
|
|---|---|---|---|---|
|
Changes in CD4 CD38+ HLADR+ (%)
|
2.3 percentage of CD4 T cells
Interval 1.4 to 5.5
|
4 percentage of CD4 T cells
Interval 2.6 to 4.4
|
1.8 percentage of CD4 T cells
Interval 1.0 to 2.5
|
2.2 percentage of CD4 T cells
Interval 1.6 to 3.0
|
Adverse Events
EFV/FTC/TDF
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
EFV/FTC/TDF + Losartan
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
FTC/TDF + MK-0518
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FTC/TDF+MK-0518+Losartan
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EFV/FTC/TDF
n=12 participants at risk
EFV/FTC/TDF: 600/200/245 mg, od, oral
|
EFV/FTC/TDF + Losartan
n=10 participants at risk
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.
|
FTC/TDF + MK-0518
n=10 participants at risk
FTC/TDF + MK-0518: FTC/TDF --\> 200/245 mg, oral MK-0518 --\> 400 mg, oral
|
FTC/TDF+MK-0518+Losartan
n=10 participants at risk
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.
|
|---|---|---|---|---|
|
Nervous system disorders
Post lumbar puncture headache
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Vascular disorders
High Blood Pressure
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
|
Hepatobiliary disorders
Liver tests abonormalities
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Infections and infestations
Sexual transmitted diseases
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
|
Psychiatric disorders
Asthenia
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Endocrine disorders
Gynecomastia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
|
Psychiatric disorders
Dysthimia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place