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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL123351-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ragon Institute of MGH, MIT and Harvard | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institutes of Health (NIH) | NIH |
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The purpose of this research study is to determine whether teduglutide can repair a "leaky" gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to inflammatory changes and leakiness of the gut. These changes or conditions may increase the risk of developing heart and blood vessel disease. The investigators believe teduglutide can help repair the gut barrier in people with HIV, leading to a decrease in inflammation and plaque in the blood vessels of the heart.
As more people with HIV gain access to combination antiretroviral therapy (cART), cardiovascular disease has become increasingly prevalent and a significant cause of mortality. Activation of the innate immune system may stimulate inflammatory mechanisms of atherosclerosis development. Loss of gastrointestinal (GI) mucosal epithelial integrity and loss of CD4+ T-lymphocytes in the intestinal lamina propria occur in HIV-infected patients and are not fully restored by cART. Translocation of microbial products from the intestinal lumen into the systemic circulation has been demonstrated to be increased in HIV-infected patients and the investigators hypothesize that it is a key driver of monocyte and macrophage activation. In turn, these pro-inflammatory monocytes and macrophages can induce atherosclerotic disease development. The purpose of the research study is to determine the effects of a glucagon-like peptide-2 analog, teduglutide, on intestinal epithelial integrity, microbial translocation across the gut lumen, markers of innate immune system activation including the monocyte transcriptome, bone, arterial inflammation, and atherosclerosis in a 6-month randomized, double-blind placebo-controlled proof of concept trial in HIV-infected individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide | Experimental | Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration |
|
| Placebo | Placebo Comparator | Placebo, subcutaneous injection, 6 months duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake | 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. | Change from baseline at 6 months |
| Change in Intestinal Epithelial Integrity | 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. | Change from baseline at 6 months |
| Change in Soluble CD14 Concentration | Soluble CD14 is a marker of monocyte activation. An increase in soluble CD14 concentration indicates an increase in inflammation. | Change from baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intestinal CD4+ T-cells | 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. | Change from baseline at 6 months |
Not provided
Inclusion Criteria:
Men and women age 21-65 with previously diagnosed HIV disease
Stable anti-retroviral therapy (ART) as defined by no changes in ART regimen for >6 months
HIV viral load < 200 copies/mL
To be eligible for colonoscopy procedure, laboratory values that meet the following criteria:
4. Ability and willingness to give written informed consent and to comply with study requirements
Exclusion Criteria:
History of clinically significant gastrointestinal disease including but not limited to: colon cancer, intestinal obstruction, ulcerative colitis, Crohn's disease, or history of C. difficile within the past 3 months
First-degree relative with history of colon cancer
Active gall bladder, biliary or pancreatic disease
Female subject who is pregnant, nursing or less than 8 weeks post partum.
Use of any immunomodulatory agents within 30 days prior to study enrollment
History of intolerance, sensitivity, allergy or anaphylaxis to benzodiazepines or other narcotics to be used during the colonoscopy or upper endoscopy procedure
Contraindication to beta-blocker (including moderate to severe asthma or heart block) or nitroglycerin use as these drugs are given as part of the standard cardiac CT protocol. Previous allergic reaction to beta blocker or nitroglycerin.
Patients with previous allergic reactions to iodine-containing contrast media
Renal disease or creatinine >1.5 mg/dL (contrast will be administered during CT angiography of the heart)
History of requiring antibiotic prophylaxis for invasive procedures
History of myocardial infarction, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study
Currently taking anticoagulants including but not limited to: heparin, warfarin (Coumadin), tinzaparin (Innohep), enoxaparin (Lovenox), danaparoid (Orgaran), dalteparin (Fragmin), clopidogrel (Plavix), prophylactic aspirin, and regular NSAID use
Subject taking any of the following medications: statins, systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of human papilloma virus is permitted), systemic chemotherapy including oral chemotherapeutic agents, methotrexate, octreotide, growth hormone, antiarrhythmics including digoxin, antiepileptics, immunosuppressants, vancomycin, rifampin, aminoglycosides, clonidine, prazosin, lithium and ritonavir-boosted lopinavir (Kaletra).
Subject has had two or more endoscopy procedures (sigmoidoscopy, upper endoscopy or colonoscopy) within the past 12 months for clinical purposes or other research studies.
Body weight greater than 300 lbs due to CT scanner table limitations
Active illicit drug use
Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as:
Patients already scheduled or being considered for a procedure or treatment
History of malignancy
Prior recipient of a HIV vaccine
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| Name | Affiliation | Role |
|---|---|---|
| Janet Lo, MD, MMSc | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Teduglutide | Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide |
| FG001 | Placebo | Placebo, subcutaneous injection, 6 months duration Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Teduglutide | Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide |
| BG001 | Placebo | Placebo, subcutaneous injection, 6 months duration Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake | 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. | 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. | Posted | Mean | Standard Deviation | ratio | Change from baseline at 6 months |
|
Baseline, 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teduglutide | Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal or epigastric pain, discomfort, cramping | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Lo, M.D., M.MSc. | Massachusetts General Hospital | 617-724-3425 | jlo@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2018 | Jan 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
| C438272 | ALX-0600 |
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| Drug |
|
| Change in CD14+CD86+CD40+ Monocytes |
Change in pro-inflammatory monocytes. A positive change indicates increased inflammation. |
| Change from baseline at 6 months |
| Change in HLA-DR+CD38+ CD8+ T Cells | Change in activated CD8+ T Cells. A positive change indicates increased inflammation. | Change from baseline at 6 months |
| Change in HLA-DR+CD38+ CD4+ T Cells | Change in activated CD4+ T Cells. A positive change indicates increased inflammation. | Change from baseline at 6 months |
| Change in Soluble CD163 Concentration | An increase in soluble CD163 concentration indicates an increase in inflammation. | Change from baseline at 6 months |
| Change in Intestinal Fatty Acid Binding Protein Concentration | An increase in I-FABP indicates an increase in intestinal mucosal damage. | Change from baseline at 6 months |
| Change in Plasma Riboflavin Concentration | 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. | Change from baseline at 6 months |
| Change in Bone Mineral Density | Change in femoral neck bone mineral density. An increase in bone mineral density is beneficial for bone health. | Change from baseline at 6 months |
| Change in Plaque Volume on Cardiac Computed Tomography Angiography | Noncalcified plaque volume. Increased noncalcified plaque volume may indicate increased atherosclerosis. | Change from baseline at 6 months |
| Change in Hemoglobin A1c Percentage | A higher hemoglobin A1c percentage indicates a higher blood glucose level over a 3 month average. | Change from baseline at 6 months |
| Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) | 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. | Change from baseline at 6 months |
| Change in Visceral Adipose Tissue (VAT) Area | Abdominal VAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. VAT is considered metabolically unhealthy fat. | Change from baseline at 6 months |
| Change in Subcutaneous Adipose Tissue (SAT) Area | Abdominal SAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. | Change from baseline at 6 months |
| Change in Body Mass Index (BMI) | BMI is a measure of adiposity. | Change from baseline at 6 months |
| Change in Depressive Symptoms | Change in the Center for Epidemiological Studies-Depression (CES-D) score. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | Change from baseline at week 12 and at week 24 |
| Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score | 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. | Change from baseline at week 24 |
| Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score | 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. | Change from baseline at week 24 |
| Withdrawal by Subject |
|
| Declined to take study medication |
|
| Withdrew before starting study medication |
|
| Placebo shortage |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Active Smoker | Count of Participants | Participants |
|
| Current antiretroviral therapy (ART) use | Count of Participants | Participants |
|
| Current non-nucleoside reverse transcriptase inhibitors (NNRTIs) use | Count of Participants | Participants |
|
| Current protease inhibitor (PI) use | Count of Participants | Participants |
|
| Current integrase strand transfer inhibitor (INSTI) use | Count of Participants | Participants |
|
| CD4+ T-cell count | Mean | Standard Deviation | cells/mm^3 |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Current statin use | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | HbA1c, % |
|
| Total cholesterol | Mean | Standard Deviation | mg/dL |
|
| Low density lipoprotein (LDL) cholesterol | Mean | Standard Deviation | mg/dL |
|
| High density lipoprotein (HDL) cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
| OG000 |
| Teduglutide |
Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Teduglutide |
| OG001 | Placebo | Placebo, subcutaneous injection, 6 months duration Placebo |
|
|
|
| Primary | Change in Intestinal Epithelial Integrity | 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. | 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. | Posted | Mean | Standard Deviation | log2 ratio | Change from baseline at 6 months |
|
|
|
|
| Primary | Change in Soluble CD14 Concentration | Soluble CD14 is a marker of monocyte activation. An increase in soluble CD14 concentration indicates an increase in inflammation. | 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. | Posted | Mean | Standard Deviation | ng/mL | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Intestinal CD4+ T-cells | 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. | 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. | Posted | Mean | Standard Deviation | percentage of CD4+ T-cells | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in CD14+CD86+CD40+ Monocytes | Change in pro-inflammatory monocytes. A positive change indicates increased inflammation. | 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. | Posted | Mean | Standard Deviation | percentage of CD14+ monocytes | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in HLA-DR+CD38+ CD8+ T Cells | Change in activated CD8+ T Cells. A positive change indicates increased inflammation. | 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. | Posted | Mean | Standard Deviation | percentage of T Cells | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in HLA-DR+CD38+ CD4+ T Cells | Change in activated CD4+ T Cells. A positive change indicates increased inflammation. | 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. | Posted | Mean | Standard Deviation | percentage of T Cells | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Soluble CD163 Concentration | An increase in soluble CD163 concentration indicates an increase in inflammation. | 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. | Posted | Mean | Standard Deviation | ng/mL | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Intestinal Fatty Acid Binding Protein Concentration | An increase in I-FABP indicates an increase in intestinal mucosal damage. | 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. | Posted | Median | Inter-Quartile Range | pg/mL | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Plasma Riboflavin Concentration | 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. | 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. | Posted | Mean | Standard Deviation | log2 ratio | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Bone Mineral Density | Change in femoral neck bone mineral density. An increase in bone mineral density is beneficial for bone health. | 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. | Posted | Mean | Standard Deviation | g/cm^2 | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Plaque Volume on Cardiac Computed Tomography Angiography | Noncalcified plaque volume. Increased noncalcified plaque volume may indicate increased atherosclerosis. | 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. | Posted | Median | Inter-Quartile Range | mm^3 | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Hemoglobin A1c Percentage | A higher hemoglobin A1c percentage indicates a higher blood glucose level over a 3 month average. | 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. | Posted | Median | Inter-Quartile Range | HbA1c, % | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) | 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. | 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. | Posted | Mean | Standard Deviation | index | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Visceral Adipose Tissue (VAT) Area | Abdominal VAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. VAT is considered metabolically unhealthy fat. | 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. | Posted | Mean | Standard Deviation | cm^2 | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Subcutaneous Adipose Tissue (SAT) Area | Abdominal SAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. | 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. | Posted | Mean | Standard Deviation | cm^2 | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Body Mass Index (BMI) | BMI is a measure of adiposity. | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Change from baseline at 6 months |
|
|
|
|
| Secondary | Change in Depressive Symptoms | Change in the Center for Epidemiological Studies-Depression (CES-D) score. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | 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. | Posted | Median | Inter-Quartile Range | CES-D score | Change from baseline at week 12 and at week 24 |
|
|
|
|
| Secondary | Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score | 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. | 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. | Posted | Mean | Standard Deviation | z-score | Change from baseline at week 24 |
|
|
|
|
| Secondary | Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score | 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. | 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. | Posted | Mean | Standard Deviation | z-score | Change from baseline at week 24 |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 10 |
| 17 |
| EG001 | Placebo | Placebo, subcutaneous injection, 6 months duration Placebo | 0 | 15 | 0 | 15 | 12 | 15 |
| Burping, gas | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Loose stool, diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea, emesis | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Viral gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
|
| Colonoscopy procedure-related adverse event | Gastrointestinal disorders | Systematic Assessment |
|
| Emesis following IV contrast | Gastrointestinal disorders | Systematic Assessment |
|
| Tubular adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hyperplastic polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Sessile serrated polyp and polypoid of colonic mucosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Bruising at injection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bleeding at injection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Numbness at injection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Itching, burning at injection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Self-reported weight loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Self-reported weight gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Lightheadedness when taking the study drug and antiretroviral therapy together | General disorders | Systematic Assessment |
|
| Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change from baseline at week 12 |
|
|
| 0.25 |
| Superiority |