Standardized kudzu for Sexually Transmitted Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sexually Transmitted Diseases+3 More
Standardized kudzu - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether kudzu, an herbal supplement, can reduce heavy alcohol use and alcohol-associated sexual behaviors among sexually-active, binge-drinking individuals at high risk for HIV infection.

Eligible Conditions
  • Sexually Transmitted Diseases
  • Alcohol Use Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 30 days

30 days
number of condomless sexual intercourse events
number of sexual intercourse partners
proportion of participants testing positive of sexually transmitted diseases
7 days
number of binge drinking days
proportion of ethyl glucuronide (EtG) positive urines

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Kudzu
1 of 2
Control
1 of 2
Experimental Treatment
Non-Treatment Group

120 Total Participants · 2 Treatment Groups

Primary Treatment: Standardized kudzu · Has Placebo Group · Phase 2

KudzuExperimental Group · 7 Interventions: Sexually transmitted infection testing:, Standardized kudzu, Behavioral survey measurements:, Medical Management (MM) counseling for alcohol use:, Urinalysis for novel alcohol biochemical markers for recent alcohol use:, Ecological Momentary Assessment procedure:, Dried Blood Spot (DBS) Testing for PEth: · Intervention Types: DiagnosticTest, Drug, Behavioral, Behavioral, DiagnosticTest, Behavioral, DiagnosticTest
ControlPlaceboComparator Group · 7 Interventions: Sexually transmitted infection testing:, Placebo, Behavioral survey measurements:, Medical Management (MM) counseling for alcohol use:, Urinalysis for novel alcohol biochemical markers for recent alcohol use:, Ecological Momentary Assessment procedure:, Dried Blood Spot (DBS) Testing for PEth: · Intervention Types: DiagnosticTest, Other, Behavioral, Behavioral, DiagnosticTest, Behavioral, DiagnosticTest

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days

Who is running the clinical trial?

Glenn-Milo SantosLead Sponsor
2 Previous Clinical Trials
76 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
710 Previous Clinical Trials
1,170,671 Total Patients Enrolled
2 Trials studying Sexually Transmitted Diseases
470 Patients Enrolled for Sexually Transmitted Diseases
Glenn-Milo Santos, PhD, MPHPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
2 Previous Clinical Trials
76 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Individuals who had anal or vaginal sex while under the influence of alcohol, or missed ART or PrEP due to alcohol use, in the prior 3 months were more likely to be diagnosed with HIV.
drank heavily at least once a week for the past three months.
Someone who has an AUD by DSM-5 SCID criteria (includes hazardous and harmful use) is someone who meets the criteria for an AUD according to the DSM-5 Structured Clinical Interview for DSM-5 Disorders (SCID)
This individual has tested negative for HIV using a rapid antibody test and a pooled RNA test, or if they are HIV positive, they have a medical record documentation of HIV infection and a CD4 cell count of more than 100 cells/mm3 and a suppressed HIV viral load of less than 50 copies/mm3.
The only people in the household currently experiencing any health problems are those who are relatively healthy and do not require extensive medical care.
No chronic illnesses that are likely to progress clinically during the trial period will be allowed.
able and willing to provide written consent and attend all study visits.
The subject had a baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history.
People aged 18 to 70 years can take part in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.