Trial Outcomes & Findings for A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV (NCT NCT02431325)

NCT ID: NCT02431325

Last Updated: 2023-06-12

Results Overview

Change in maximum target to background ratio (TBRmax) of the most diseased segment (MDS) of the carotid index vessel. A negative number for the change in TBR implies a reduction in activity over time, which is considered an improvement in carotid arterial inflammation. Arterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the mean value, of the TBR, from baseline to 6 months.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: Change from baseline at 6 months
• Results posted on: 2023-06-12

Participant Flow

Participant milestones

Measure	Teduglutide Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo Placebo, subcutaneous injection, 6 months duration Placebo
Overall Study STARTED	17	15
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	Teduglutide Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo Placebo, subcutaneous injection, 6 months duration Placebo
Overall Study Adverse Event	3	0
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	2
Overall Study Declined to take study medication	1	0
Overall Study Withdrew before starting study medication	1	0
Overall Study Placebo shortage	2	0

Baseline Characteristics

A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV

Baseline characteristics by cohort

Measure	Teduglutide n=17 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=15 Participants Placebo, subcutaneous injection, 6 months duration Placebo	Total n=32 Participants Total of all reporting groups
Age, Continuous	58.3 years n=5 Participants	54.6 years n=7 Participants	56.1 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Active Smoker	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Current antiretroviral therapy (ART) use	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Current non-nucleoside reverse transcriptase inhibitors (NNRTIs) use	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Current protease inhibitor (PI) use	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Current integrase strand transfer inhibitor (INSTI) use	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
CD4+ T-cell count	639 cells/mm^3 STANDARD_DEVIATION 165 • n=5 Participants	685 cells/mm^3 STANDARD_DEVIATION 225 • n=7 Participants	660 cells/mm^3 STANDARD_DEVIATION 193 • n=5 Participants
Body mass index (BMI)	27.1 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants	28.6 kg/m^2 STANDARD_DEVIATION 4.4 • n=7 Participants	27.8 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants
Current statin use	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
HbA1c	5.5 HbA1c, % STANDARD_DEVIATION 0.4 • n=5 Participants	5.6 HbA1c, % STANDARD_DEVIATION 0.3 • n=7 Participants	5.6 HbA1c, % STANDARD_DEVIATION 0.3 • n=5 Participants
Total cholesterol	180.82 mg/dL STANDARD_DEVIATION 32.78 • n=5 Participants	186.33 mg/dL STANDARD_DEVIATION 35.04 • n=7 Participants	183.41 mg/dL STANDARD_DEVIATION 33.42 • n=5 Participants
Low density lipoprotein (LDL) cholesterol	102.53 mg/dL STANDARD_DEVIATION 27.93 • n=5 Participants	113.93 mg/dL STANDARD_DEVIATION 33.28 • n=7 Participants	107.88 mg/dL STANDARD_DEVIATION 30.60 • n=5 Participants
High density lipoprotein (HDL) cholesterol	50.94 mg/dL STANDARD_DEVIATION 16.54 • n=5 Participants	48.33 mg/dL STANDARD_DEVIATION 17.54 • n=7 Participants	49.72 mg/dL STANDARD_DEVIATION 16.79 • n=5 Participants
Triglycerides	136.59 mg/dL STANDARD_DEVIATION 55.28 • n=5 Participants	120.47 mg/dL STANDARD_DEVIATION 42.93 • n=7 Participants	129.03 mg/dL STANDARD_DEVIATION 49.76 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with interpretable FDG-PET scans at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in maximum target to background ratio (TBRmax) of the most diseased segment (MDS) of the carotid index vessel. A negative number for the change in TBR implies a reduction in activity over time, which is considered an improvement in carotid arterial inflammation. Arterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the mean value, of the TBR, from baseline to 6 months.

Outcome measures

Measure	Teduglutide n=5 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake	-0.28 ratio Standard Deviation 0.29	0.01 ratio Standard Deviation 0.35

PRIMARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with available metabolite assessments at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in plasma citrulline is calculated as log2 of the ratio of plasma citrulline at study end to baseline. Citrulline is a measure of functional small bowel mass, so a positive number is considered an improvement in intestinal epithelial integrity.

Outcome measures

Measure	Teduglutide n=8 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Intestinal Epithelial Integrity	0.39 log2 ratio Standard Deviation 0.67	-0.10 log2 ratio Standard Deviation 0.22

PRIMARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with soluble CD14 available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Soluble CD14 is a marker of monocyte activation. An increase in soluble CD14 concentration indicates an increase in inflammation.

Outcome measures

Measure	Teduglutide n=8 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Soluble CD14 Concentration	117.70 ng/mL Standard Deviation 387.56	142.85 ng/mL Standard Deviation 242.01

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with available biopsy samples from endoscopies at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in CD161+CCR6+ (Th17) cells as a percentage of CD4+ T-cells in the duodenum. An increase in Th17 cells indicates a beneficial restoration of this CD4+ T-cell population in the small intestine, which are pathologically depleted in people with HIV.

Outcome measures

Measure	Teduglutide n=7 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Intestinal CD4+ T-cells	13.17 percentage of CD4+ T-cells Standard Deviation 18.15	-4.81 percentage of CD4+ T-cells Standard Deviation 15.98

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with peripheral blood flow cytometry data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. Two participants in the placebo group did not have interpretable data for this monocyte population.

Change in pro-inflammatory monocytes. A positive change indicates increased inflammation.

Outcome measures

Measure	Teduglutide n=7 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=8 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in CD14+CD86+CD40+ Monocytes	-19.24 percentage of CD14+ monocytes Standard Deviation 14.12	-3.31 percentage of CD14+ monocytes Standard Deviation 13.97

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with peripheral blood flow cytometry at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in activated CD8+ T Cells. A positive change indicates increased inflammation.

Outcome measures

Measure	Teduglutide n=7 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in HLA-DR+CD38+ CD8+ T Cells	-0.33 percentage of T Cells Standard Deviation 0.68	0.67 percentage of T Cells Standard Deviation 1.22

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with peripheral blood flow cytometry at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in activated CD4+ T Cells. A positive change indicates increased inflammation.

Outcome measures

Measure	Teduglutide n=7 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in HLA-DR+CD38+ CD4+ T Cells	0.0013 percentage of T Cells Standard Deviation 0.19	0.058 percentage of T Cells Standard Deviation 0.31

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with soluble CD163 data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

An increase in soluble CD163 concentration indicates an increase in inflammation.

Outcome measures

Measure	Teduglutide n=8 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=9 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Soluble CD163 Concentration	-9.26 ng/mL Standard Deviation 102.74	22.77 ng/mL Standard Deviation 85.95

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with I-FABP data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

An increase in I-FABP indicates an increase in intestinal mucosal damage.

Outcome measures

Measure	Teduglutide n=8 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=9 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Intestinal Fatty Acid Binding Protein Concentration	-270.04 pg/mL Interval -675.05 to 1858.38	-215.27 pg/mL Interval -458.12 to 213.77

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with metabolite assessments at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in plasma riboflavin is calculated as log2 of the ratio of plasma riboflavin at study end to baseline. A positive number indicates an increase in riboflavin levels.

Outcome measures

Measure	Teduglutide n=8 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Plasma Riboflavin Concentration	0.55 log2 ratio Standard Deviation 0.77	-0.36 log2 ratio Standard Deviation 0.89

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with bone density scans at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in femoral neck bone mineral density. An increase in bone mineral density is beneficial for bone health.

Outcome measures

Measure	Teduglutide n=6 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Bone Mineral Density	0.015 g/cm^2 Standard Deviation 0.021	-0.0078 g/cm^2 Standard Deviation 0.022

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with available cardiac CT data at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Noncalcified plaque volume. Increased noncalcified plaque volume may indicate increased atherosclerosis.

Outcome measures

Measure	Teduglutide n=6 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Plaque Volume on Cardiac Computed Tomography Angiography	-0.74 mm^3 Interval -9.86 to 0.81	0.00 mm^3 Interval -13.08 to 0.14

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with HbA1c assessed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

A higher hemoglobin A1c percentage indicates a higher blood glucose level over a 3 month average.

Outcome measures

Measure	Teduglutide n=8 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Hemoglobin A1c Percentage	-0.1 HbA1c, % Interval -0.1 to 0.2	-0.1 HbA1c, % Interval -0.3 to 0.0

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with fasting glucose and fasting insulin assessed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention and one participant in the active group that was not fasting for the study end blood draw.

A higher HOMA-IR indicates greater insulin resistance. Values greater than 2 suggests insulin resistance. HOMA-IR was calculated using a formula based on Matthews et al. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28(7):412-419.

Outcome measures

Measure	Teduglutide n=7 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)	-0.40 index Standard Deviation 2.86	1.13 index Standard Deviation 3.20

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with single-slice abdominal CT scans performed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Abdominal VAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. VAT is considered metabolically unhealthy fat.

Outcome measures

Measure	Teduglutide n=6 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Visceral Adipose Tissue (VAT) Area	-12.09 cm^2 Standard Deviation 46.59	-7.94 cm^2 Standard Deviation 32.72

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with single-slice abdominal CT scans performed at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Abdominal SAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra.

Outcome measures

Measure	Teduglutide n=6 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Subcutaneous Adipose Tissue (SAT) Area	-9.71 cm^2 Standard Deviation 39.91	-0.11 cm^2 Standard Deviation 17.60

SECONDARY outcome

Timeframe: Change from baseline at 6 months

Population: The subset of participants with heights and weights measured at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

BMI is a measure of adiposity.

Outcome measures

Measure	Teduglutide n=6 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=10 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Body Mass Index (BMI)	-0.33 kg/m^2 Standard Deviation 0.94	-0.27 kg/m^2 Standard Deviation 1.14

SECONDARY outcome

Timeframe: Change from baseline at week 12 and at week 24

Population: The subset of participants with complete depression scales obtained by self-administered survey at baseline, 12 weeks, and 24 weeks, excluding one participant in the placebo group that discontinued ART during the intervention. Some participants that had depression scales at 24 weeks did not have them available at 12 weeks.

Change in the Center for Epidemiological Studies-Depression (CES-D) score. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

Outcome measures

Measure	Teduglutide n=7 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=11 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Depressive Symptoms Change from baseline at week 24	1 CES-D score Interval -3.0 to 3.0	-3 CES-D score Interval -6.0 to 0.0
Change in Depressive Symptoms Change from baseline at week 12	0 CES-D score Interval -3.0 to 4.0	3 CES-D score Interval -1.0 to 13.0

SECONDARY outcome

Timeframe: Change from baseline at week 24

Population: The subset of participants with neurocognitive testing results at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

The Global Neurocognitive Z-Score is calculated as an average of the z-scores from the following neurocognitive assessments: Hopkins Verbal Learning Test (HVLT) Total Recall, HVLT Delayed Recall, HVLT Retention, HVLT Recognition, Wechsler Adult Intelligence Scale (WAIS) Digit Span Forward, WAIS Digit Span Backward, WAIS Digit Span Sequence, Stroop Word, Stroop Color, Stroop Color Word, Stroop Interference, Grooved Pegboard Dominant, and Grooved Pegboard Nondominant. A z-score of 0 corresponds with the population mean, and a positive z-score indicates better neurocognitive function than the population mean. A positive change indicates an improvement in neurocognitive function, and a negative change indicates a detriment to performance over time.

Outcome measures

Measure	Teduglutide n=5 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=9 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score	0.23 z-score Standard Deviation 0.39	-0.04 z-score Standard Deviation 0.85

SECONDARY outcome

Timeframe: Change from baseline at week 24

Population: The subset of participants with neurocognitive testing results at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.

Change in motor-specific performance z-score. A z-score of 0 corresponds with the population mean, and a positive z-score indicates better motor-specific performance than the population mean. A positive change indicates an improvement in motor-specific performance, and a negative change indicates a detriment to performance over time.

Outcome measures

Measure	Teduglutide n=5 Participants Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=9 Participants Placebo, subcutaneous injection, 6 months duration Placebo
Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score	1.73 z-score Standard Deviation 2.48	-0.52 z-score Standard Deviation 1.72

Adverse Events

Teduglutide

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Teduglutide n=17 participants at risk Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide	Placebo n=15 participants at risk Placebo, subcutaneous injection, 6 months duration Placebo
Gastrointestinal disorders Abdominal or epigastric pain, discomfort, cramping	29.4% 5/17 • Baseline, 6 months	20.0% 3/15 • Baseline, 6 months
Gastrointestinal disorders Burping, gas	17.6% 3/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Gastrointestinal disorders Bloating	35.3% 6/17 • Baseline, 6 months	20.0% 3/15 • Baseline, 6 months
Gastrointestinal disorders Constipation	23.5% 4/17 • Baseline, 6 months	13.3% 2/15 • Baseline, 6 months
Gastrointestinal disorders Loose stool, diarrhea	11.8% 2/17 • Baseline, 6 months	26.7% 4/15 • Baseline, 6 months
Gastrointestinal disorders Nausea, emesis	11.8% 2/17 • Baseline, 6 months	0.00% 0/15 • Baseline, 6 months
Gastrointestinal disorders Decreased appetite	5.9% 1/17 • Baseline, 6 months	0.00% 0/15 • Baseline, 6 months
Gastrointestinal disorders Viral gastroenteritis	0.00% 0/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Gastrointestinal disorders Esophagitis	5.9% 1/17 • Baseline, 6 months	0.00% 0/15 • Baseline, 6 months
Gastrointestinal disorders Colonoscopy procedure-related adverse event	11.8% 2/17 • Baseline, 6 months	13.3% 2/15 • Baseline, 6 months
Gastrointestinal disorders Emesis following IV contrast	0.00% 0/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tubular adenoma	0.00% 0/17 • Baseline, 6 months	20.0% 3/15 • Baseline, 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hyperplastic polyp	11.8% 2/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sessile serrated polyp and polypoid of colonic mucosa	0.00% 0/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Injury, poisoning and procedural complications Bruising at injection site	11.8% 2/17 • Baseline, 6 months	20.0% 3/15 • Baseline, 6 months
Injury, poisoning and procedural complications Bleeding at injection site	0.00% 0/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Injury, poisoning and procedural complications Numbness at injection site	0.00% 0/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Injury, poisoning and procedural complications Itching, burning at injection site	0.00% 0/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Metabolism and nutrition disorders Self-reported weight loss	5.9% 1/17 • Baseline, 6 months	0.00% 0/15 • Baseline, 6 months
Metabolism and nutrition disorders Self-reported weight gain	0.00% 0/17 • Baseline, 6 months	20.0% 3/15 • Baseline, 6 months
General disorders Lightheadedness when taking the study drug and antiretroviral therapy together	0.00% 0/17 • Baseline, 6 months	6.7% 1/15 • Baseline, 6 months
Respiratory, thoracic and mediastinal disorders Respiratory symptoms	23.5% 4/17 • Baseline, 6 months	0.00% 0/15 • Baseline, 6 months

Additional Information

Janet Lo, M.D., M.MSc.

Massachusetts General Hospital

Phone: 617-724-3425

Email: jlo@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60