Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study
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ClinicalTrials.gov Identifier: NCT02531295 |
Recruitment Status :
Suspended
(Temporary pause on non-COVID clinical trial recruitment at study site)
First Posted : August 24, 2015
Last Update Posted : March 23, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Human Immunodeficiency Virus | Drug: Euphorbia kansui extract powder prepared as tea | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Immunologic Response to Euphorbia Kansui Extract Powder Prepared as Tea in HIV-infected Antiretroviral Therapy (ART)-Suppressed Individuals: a Dose Escalation Study |
Actual Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Kansui 1g per day x 1 day
Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose.
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Drug: Euphorbia kansui extract powder prepared as tea
1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily
Other Name: Kansui |
Experimental: Kansui 1g per day x 2 days
Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses.
|
Drug: Euphorbia kansui extract powder prepared as tea
1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily
Other Name: Kansui |
Experimental: Kansui 1g per day x 3 days
Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses.
|
Drug: Euphorbia kansui extract powder prepared as tea
1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily
Other Name: Kansui |
- Safety of Euphorbia kansui extract powder prepared as tea assessed by the number of grade 2 or higher severity adverse events or drug-related laboratory abnormalities that exceed a frequency of 5% [ Time Frame: 31 days ]The number of grade 2 or higher severity adverse events (AEs) or drug-related laboratory abnormalities that exceed a frequency of 5% over a 31 day study period.
- Early T cell immune activation (%CD69+ CD4+ and CD8+ T cells) [ Time Frame: 31 days ]The change in early immune activation levels (as measured by the %CD69+ CD4+ and CD8+ T cells) over a 31 day study period.
- T cell immune activation (%CD38+HLA-DR+ CD4+ and CD8+ T cells) [ Time Frame: 31 days ]The change in immune activation levels (as measured by the %CD38+HLADR+ CD4+ and CD8+ T cells) over a 31 day study period.
- HIV reservoir size (cell-associated HIV RNA) [ Time Frame: 31 days ]The change in HIV reservoir size (as measured by cell-associated HIV RNA levels) over a 31 day study period.
- HIV reservoir size (plasma HIV RNA) [ Time Frame: 31 days ]The change in HIV reservoir size (as measured by ultra-sensitive plasma HIV RNA levels) over a 31 day study period.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed HIV-1 infection in adults aged 18 years or older.
- Continuous therapy with a DHHS recommended/alternative combination ART for least 36 months (at least 3 agents) at study entry with no regimen changes in the preceding 24 weeks.
- Maintenance of undetectable plasma HIV-1 RNA (<40 copies/ml) for at least 36 months. Episodes of single HIV plasma RNA 50-500 copies.ml will not exclude participation if subsequent HIV plasma RNA is <40 copies/ml.
- Two CD4+ T cell counts >350 cells/μl in the six months prior to screening.
Exclusion Criteria:
- Pre-ART viral load <2000 copies/ml (HIV controllers)
- Based on prior history and/or virologic testing, no alternative ART regimens are available in the event that the current ART regimen is compromised as a result of this study.
- Recent hospitalization in the last 90 days.
- Recent infection in the last 90 days requiring systemic antibiotics.
- Recent vaccination within the last 8 weeks prior to study scree or any study blood draw.
- Any known history of liver-related diseases including but not limited to: hepatic cirrhosis of decompensated chronic liver diseases; clinically active hepatitis B or C infection as evidenced by clinical jaundice or Grade 2 or higher liver function test abnormalities; any hepatic impairment, regardless of the graded liver function test abnormalities.
- Any known history of gastrointestinal diseases including but not limited to: history of diarrheal illness requiring the use of anti-motility agents including inflammatory bowel disease, chronic diarrhea not otherwise specified; history of gastrointestinal bleeding with hemoglobin below 12.5 g/dL; history of gastric or duodenal ulcers; inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis
- Any renal disease (eGFR < 90 ml/min) or acute nephritis.
- Screening hemoglobin below 12.5 g/dL.
- Screening TSH consistent with hypothyroidism.
- Significant myocardial disease (current myocarditis or reduced left ventricular ejection fraction below the lower limit of normal) or diagnosed coronary artery disease.
- Significant respiratory disease requiring oxygen.
- Diabetes or current hypothyroidism.
- Participants of reproductive potential or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at screening. All participants of childbearing potential must agree to use a double-barrier method of contraception throughout the study period and up to 90 days after the last dose of kansui.
- Exposure to any immunomodulatory drug (including maraviroc) in the16 weeks prior to study.
- Prior or current use of experiment agents used with the intent to perturb the HIV-1 viral reservoir.
- History of seizures, psychosis, abnormal electroencephalogram or brain damage with significant persisting neurological deficit
- Positive test for tuberculosis by either skin test (PPD) or blood interferon-gamma release assay (QuantiFERON).
- Significant substance use, which in the opinion of the investigator(s), is likely to interfere with the conduct of the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531295
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | Sulggi A Lee, MD PhD | University of California, San Francisco | |
Principal Investigator: | Adam M Spivak, MD | University of Utah |
Responsible Party: | Sulggi A. Lee, MD, PhD, Principal Investigator, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02531295 |
Other Study ID Numbers: |
University of Utah #00100155 |
First Posted: | August 24, 2015 Key Record Dates |
Last Update Posted: | March 23, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Blood-Borne Infections Communicable Diseases Infections |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases |