Trial Outcomes & Findings for Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial (NCT NCT02049307)
NCT ID: NCT02049307
Last Updated: 2019-12-10
Results Overview
Difference between treatment and control IL-6 plasma levels from pre-treatment to on-treatment values
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2019-12-10
Participant Flow
Participant milestones
| Measure |
Treatment (Losartan)
Participants receive Losartan 100mg daily
|
Placebo
Participants receive a matching placebo daily
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
56
|
|
Overall Study
COMPLETED
|
50
|
55
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
Baseline characteristics by cohort
| Measure |
Treatment (Losartan)
n=52 Participants
Participants receive Losartan 100mg daily
|
Placebo
n=56 Participants
Participants receive a matching placebo daily
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic - Black
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic - White
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic - Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
56 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
IL-6
|
0.91 pg/mL
n=5 Participants
|
1.04 pg/mL
n=7 Participants
|
0.97 pg/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsDifference between treatment and control IL-6 plasma levels from pre-treatment to on-treatment values
Outcome measures
| Measure |
Treatment
n=52 Participants
Losartan 100mg daily
Losartan 100mg daily
|
Placebo
n=56 Participants
Matching placebo
Matching placebo
|
|---|---|---|
|
Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 12 Months
|
0.14 pg/mL
Standard Deviation 1.22
|
0.29 pg/mL
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsChange in cluster of differentiation 4 (CD4+) cell count from baseline to 12 months
Outcome measures
| Measure |
Treatment
n=52 Participants
Losartan 100mg daily
Losartan 100mg daily
|
Placebo
n=56 Participants
Matching placebo
Matching placebo
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to 12 Months.
|
15.1 Cells/mm^3
Standard Error 7.6
|
6.8 Cells/mm^3
Standard Error 7.3
|
Adverse Events
Treatment (Losartan)
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Losartan)
n=52 participants at risk
Losartan 100mg provided daily
|
Placebo
n=56 participants at risk
Matching placebo provided daily
|
|---|---|---|
|
Vascular disorders
Mesenteric Vein Thrombosis
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Vascular disorders
Ischaemic Stroke
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypoglossal Nerve Disorder
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
Other adverse events
| Measure |
Treatment (Losartan)
n=52 participants at risk
Losartan 100mg provided daily
|
Placebo
n=56 participants at risk
Matching placebo provided daily
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dizziness
|
5.8%
3/52 • Number of events 3 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
General disorders
Fall
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Fatigue
|
5.8%
3/52 • Number of events 3 • 12 months
|
3.6%
2/56 • Number of events 2 • 12 months
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
General disorders
Insomnia
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Ligament Sprain
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
General disorders
Malaise
|
5.8%
3/52 • Number of events 3 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Nervous system disorders
Somnambulism
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Nervous system disorders
Vertigo
|
1.9%
1/52 • Number of events 1 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/52 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Alanine Aminotransferase Increased
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Gastrointestinal disorders
Aspartate Aminotransferase Increased
|
3.8%
2/52 • Number of events 2 • 12 months
|
0.00%
0/56 • 12 months
|
|
Ear and labyrinth disorders
Deafness
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Immune system disorders
Leukopenia
|
1.9%
1/52 • Number of events 1 • 12 months
|
0.00%
0/56 • 12 months
|
|
Endocrine disorders
Diabetes Mellitus Type 2
|
1.9%
1/52 • Number of events 1 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/52 • Number of events 1 • 12 months
|
1.8%
1/56 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place