HIV InfectionPhase 2NCT01184456
A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System
A Phase 2 study testing GanedenBC30, GBI-30, PTA-6086 in people with HIV Infection and Gastrointestinal Symptoms, run by AIDS Healthcare Foundation at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Gastrointestinal Symptoms
- What is being tested?
- GanedenBC30, GBI-30, PTA-6086
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Karnofsky performance status - 60%.
- Adequate laboratory parameters within the last 30 days:
- absolute neutrophil count >1000 cells/cubic mm
- hemoglobin >9.0 g/dL
- platelets >75,000/cubic mm
- creatinine <1.5 x upper limit of normal
- SGOT/SGPT <3.0 x upper limit of normal
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
AHF Research Center
Beverly Hills, California, 90211
About this study
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.
- Conditions
- HIV Infection, Gastrointestinal Symptoms
- Being tested
- GanedenBC30, GBI-30, PTA-6086, Placebo
- Keywords
- AIDS, Acquired Immunodeficiency Syndrome, HIV, Human Immunodeficiency Virus
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanedenBC30, GBI-30, PTA-6086Dietary supplement
Also called Bacillus coagulans, Probiotics
1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
PlaceboDrug
1 capsule per day for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| GanedenBC30, GBI-30, PTA-6086 | Experimental | Not described Receives: Dietary Supplement: GanedenBC30, GBI-30, PTA-6086 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30, 60, and 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Healthcare Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ganeden Biotech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184456
- Sponsor's protocol ID
- AHF-GAN01
- Status last verified
- Jan 2021
- First submitted
- 17 Aug 2010
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System
- ClinicalTrials.gov ID
- NCT01184456
- Acronym / sponsor ID
- AHF-GAN01
- Conditions
- HIV Infection, Gastrointestinal Symptoms
- Keywords
- AIDS, Acquired Immunodeficiency Syndrome, HIV, Human Immunodeficiency Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AIDS Healthcare FoundationUniversity, hospital or other
- Collaborators
- Ganeden Biotech, Inc.
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GanedenBC30, GBI-30, PTA-6086 | Experimental | Dietary Supplement: GanedenBC30, GBI-30, PTA-6086 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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).
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GanedenBC30, GBI-30, PTA-6086Also: Bacillus coagulans, Probiotics1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days. | Dietary supplement | GanedenBC30, GBI-30, PTA-6086 |
| Placebo1 capsule per day for 90 days. | Drug | Placebo |
Primary outcome
Effects of Daily Consumption of GanedenBC30 on Immune Function and Gastro-intestinal Issues
Time frame: 30, 60, and 90 days.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GanedenBC30, GBI-30, PTA-6086 in people with HIV Infection and Gastrointestinal Symptoms, run by AIDS Healthcare Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Daily Consumption of GanedenBC30 on Immune Function and Gastro-intestinal Issues (time frame: 30, 60, and 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.