View Clinical Trial (Medical Research Study)
A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System
| City: |
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Beverly Hills |
| State: |
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California |
| Zip Code: |
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90211 |
| Conditions: |
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HIV Infection - Gastrointestinal Symptoms |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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:
1. absolute neutrophil count >1000 cells/cubic mm
2. hemoglobin >9.0 g/dL
3. platelets >75,000/cubic mm
4. creatinine <1.5 x upper limit of normal
5. SGOT/SGPT <3.0 x upper limit of normal
6. bilirubin <2.0 mg/dL
- 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:
- Active opportunistic infection, which is progressive, or imminently disabling or life
threatening, in the judgment of the Principal Investigator with exception of Kaposi
Sarcoma.
- Cytotoxic chemotherapy, interferon treatment, or radiation therapy within the
preceding 3 weeks (subjects who have received intralesional chemotherapy will not be
excluded, however).
- Any antibiotic therapy within 30 days of enrollment
- Any probiotic formulation within 30 days of enrollment
- Any immunization within 30 days of enrollment
- Known history of allergic reactions to any of the investigational products or their
ingredients.
- Chronic treatment with immunosuppressant drugs, including corticosteroids, except for
the treatment of adrenal insufficiency. Topical steroids are permitted.
- History of or known current malabsorption syndrome.
- Any grade 3 or 4 lab abnormalities as defined by a standardized grading scheme based
on the DAIDS table (see Appendix B) with the following exceptions:
- Pre-existing diabetes with glucose toxicity elevations ≥ grade 3
- Triglyceride or total cholesterol elevations ≥ grade 3
- Clinical or laboratory evidence of clinically significant liver impairment/
dysfunction, disease or cirrhosis.
- Life expectancy < 6 months in the opinion of the investigator.
- Active substance abuse or significant psychiatric illness that in the opinion of the
investigator might interfere with study compliance.
- Female subject of childbearing potential not using effective non-hormonal birth
control methods or not willing to continue practicing these birth control methods
from screening until the last trial related activity.
- Subject is pregnant or lactating.
- Any condition that in the Principal Investigator's opinion may render the subject
unable to complete the study or which may pose significant risk to the subject.
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| NCT ID: |
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NCT01184456 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Beverly Hills, California 90211
United States
Robert Cordova, RN,BSN,CCRP
Phone: 323-913-1033
Email: Robert.Cordova@aidshealth.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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