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| Name | Class |
|---|---|
| Ganeden Biotech, Inc. | INDUSTRY |
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Improvement in the rate of bacterial translocation may lead to a decrease in a chronic inflammatory response thereby decreasing CD4 destruction and HIV proliferation.
By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in chronic inflammation and therefore an improvement in immune markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GanedenBC30, GBI-30, PTA-6086 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GanedenBC30, GBI-30, PTA-6086 | Dietary Supplement | 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Daily Consumption of GanedenBC30 on Immune Function and Gastro-intestinal Issues | The primary endpoint measurement of safety is measured based on the number of adverse events reported relative to the expected number adverse events prior to the start of the study based on a risk analysis. The primary endpoint measurement of immune function is measured based on biological markers including CRP, IL-8 and TNF-alpha between the two groups. The primary endpoint measurement of gastro-intestinal issues is measured based on the number of reported symptoms relative to the expected number of gastro-intestinal issues prior to the start of the study based on a risk analysis. | 30, 60, and 90 days. |
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Inclusion Criteria:
Patient is male or non-pregnant, non-lactating female.
Adults 18 years or older.
Is able to provide written, informed consent to participate in the study.
Serological documentation of HIV infection at any time prior to study entry and is clinically stable.
Stable CD4 count greater than or equal to 250 cells/cubic mm for six months prior to study entry (+/- 50 cells/cubic mm).
HIV-1 RNA ≤50 copies/mL for six months prior to study entry.
Karnofsky performance status - 60%.
Adequate laboratory parameters within the last 30 days:
Patients with documented GI symptoms to include but are not limited to: flatulence, diarrhea, bloating, gastroesophageal reflux disease, nausea, and constipation.
If females are of childbearing potential, they must be practicing an effective method of contraception and agree to use birth control while on protocol and for 1 month after completion of study. Women of Child Bearing Potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not. postmenopausal [defined as amenorrhea for 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Must agree to practice protected sexual activity (via barrier method) during course of the study.
In the opinion of the investigator, is willing and able to comply with the study requirements.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHF Research Center | Beverly Hills | California | 90211 | United States |
PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.
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| ID | Title | Description |
|---|---|---|
| FG000 | GanedenBC30, GBI-30, PTA-6086 | GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days. |
| FG001 | Placebo | Placebo: 1 capsule per day for 90 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.
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| ID | Title | Description |
|---|---|---|
| BG000 | GanedenBC30, GBI-30, PTA-6086 | GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days. |
| BG001 | Placebo | Placebo: 1 capsule per day for 90 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Effects of Daily Consumption of GanedenBC30 on Immune Function and Gastro-intestinal Issues | The primary endpoint measurement of safety is measured based on the number of adverse events reported relative to the expected number adverse events prior to the start of the study based on a risk analysis. The primary endpoint measurement of immune function is measured based on biological markers including CRP, IL-8 and TNF-alpha between the two groups. The primary endpoint measurement of gastro-intestinal issues is measured based on the number of reported symptoms relative to the expected number of gastro-intestinal issues prior to the start of the study based on a risk analysis. | PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available. | Posted | 30, 60, and 90 days. |
|
PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.
PI has left AIDS Healthcare Foundation, all efforts to locate the data have been exhausted and no data is available.
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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 | GanedenBC30, GBI-30, PTA-6086 | GanedenBC30, GBI-30, PTA-6086: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Sukhija-Cohen | AIDS Healthcare Foundation - Public Health Division | (323) 436-8900 | adam.cohen@aidshealth.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C562118 | exopolysaccharide biopolymer, Bacillus coagulans |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Placebo | Drug | 1 capsule per day for 90 days. |
|
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| OG001 | Placebo | Placebo: 1 capsule per day for 90 days. |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Placebo: 1 capsule per day for 90 days. | 0 | 0 | 0 | 0 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D019602 |
| Food and Beverages |