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The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
This study is evaluating the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching Placebo |
|
| SBI 2.5 g | Active Comparator | Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g |
|
| SBI 5.0g | Active Comparator | Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum-derived bovine immunoglobulin protein isolate (SBI) | Other | SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Daily Unformed Bowel Movements | Change in number of abnormal or unformed stools by week 4 | Baseline and 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418) | Lowest baseline CD4+ quartile (less than or equal to 418) | Baseline and 4 weeks |
| Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Asmuth, M.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Research Alliance | Los Angeles | California | 90015 | United States | ||
| Univ of California Davis CARES Clinic |
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Study consists of 2 phases, the Placebo-controlled (PC) phase and the Placebo-free (PF) extension phase. Participants were randomized in a 1:1:2:2 ratio into 4 groups: Placebo for 4 wk PC phase followed by either 2.5g or 5.0g BID for 20 wk PF phase or SBI 2.5g or 5.0g BID for 4-wk PC phase followed by 2.5g or 5.0g for 20 wk PF phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching Placebo Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 g |
| FG001 | SBI 2.5 g | Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-Controlled Phase |
|
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|
| Placebo | Other | Matching placebo |
|
2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630) |
| Baseline and 4 weeks |
| Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890) | 3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893) | Baseline and 4 weeks |
| Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893) | 4th Baseline CD4+ Quartile (greater than 893) | Baseline and 4 weeks |
| Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities | Baseline and Week 24 |
| Sacramento |
| California |
| 95817 |
| United States |
| Univ of California SF | San Francisco | California | 94110 | United States |
| Therafirst | Fort Lauderdale | Florida | 33308 | United States |
| Miami Springs | Florida | 33166 | United States |
| Chicago | Illinois | 600654 | United States |
| Boston | Massachusetts | 02461 | United States |
| Detroit | Michigan | 48201 | United States |
| Cincinnati | Ohio | 45206 | United States |
| Fort Worth | Texas | 76107 | United States |
| FG002 | SBI 5.0g | Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Placebo-Free Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching Placebo |
| BG001 | SBI 2.5 g | Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. |
| BG002 | SBI 5.0g | Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Years with HIV | Mean | Standard Deviation | years |
| |||||||||||||||
| Years with HIV-associated diarrhea | Mean | Standard Deviation | years |
| |||||||||||||||
| Baseline Plasma CD4+ cell count | Mean | Standard Deviation | cells/microliter |
| |||||||||||||||
| Plasma viral load | Mean | Standard Deviation | copies/mL |
|
| 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 | Frequency of Daily Unformed Bowel Movements | Change in number of abnormal or unformed stools by week 4 | Posted | Mean | Standard Deviation | abnormal or unformed stools | Baseline and 4 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418) | Lowest baseline CD4+ quartile (less than or equal to 418) | Posted | Mean | Standard Deviation | cells/microliter | Baseline and 4 weeks |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630 | 2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630) | Posted | Mean | Standard Deviation | cells/microliter | Baseline and 4 weeks |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890) | 3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893) | Posted | Mean | Standard Deviation | cells/microliter | Baseline and 4 weeks |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893) | 4th Baseline CD4+ Quartile (greater than 893) | Posted | Mean | Standard Deviation | cells/microliter | Baseline and 4 weeks |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities | Sub-study | Posted | Mean | Full Range | cells/mm3 | Baseline and Week 24 |
|
|
24 weeks
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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 | SBI 2.5 g | Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. | 2 | 55 | 26 | 55 | ||
| EG001 | SBI 5.0g | Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. | 1 | 47 | 20 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral Haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Alcohol Abuse | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | General disorders | MedDRA | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
If no multi-site publication is made within 18 months, Site may publish Site's results, subject to the following. At least 30 days prior to submitting a manuscript the Site shall provide to Entera a copy, and Entera shall have 30 days to review. Site shall remove any Confidential Information, upon Entera's request, prior to submitting the materials, and the Site shall delay publication for an additional period of up to 60 days to allow Entera to protect its interests in any Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Research | Entera Health | 515-963-7565 | audrey.shaw@enterahealth.com |
| ID | Term |
|---|---|
| D019053 | HIV Enteropathy |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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