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Tests treatment safety and results for HIV -1 Infection
Official title Safety Study of MucoCept-CVN
ClinicalTrials.gov ID: NCT07181486
What this study is testing
What is Live Biotherapeutic Product L. jensenii 1153-1666?
Live Biotherapeutic Product L. jensenii 1153-1666 is an investigational medicine, being studied as a potential treatment for hiv -1 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy pre-menopausal women 18-45 years of age, inclusive, with regular predictable menstrual cycles
- Ability to read and consent in English
- Previous experience of gynecological examinations
- Consent to participate and adhere to all procedures, including frequent visits at the UCSF Clinical Research Center (CRC) facility for at least 53...
- Agree to get tested for STIs and a Pap Smear
You likely can't join if
- Urogenital infection, including UTI, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum, HIV-1/2, BV, or...
- Abnormal Pap smear result
- Pregnancy or within two months of last pregnancy or lactation
- Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
- Investigational or immune-suppressive drug use within 30 days of enrollment visit or 10 half-lives, or planned during the study
- Intrauterine device insertion or removal, pelvic surgery, cervical cryotherapy, cervical laser or loop electrosurgical procedure, abortion...
See the full eligibility criteria
- Healthy pre-menopausal women 18-45 years of age, inclusive, with regular predictable menstrual cycles
- Ability to read and consent in English
- Previous experience of gynecological examinations
- Consent to participate and adhere to all procedures, including frequent visits at the UCSF Clinical Research Center (CRC) facility for at least 53 days
- Agree to get tested for STIs and a Pap Smear
- Agree not to use any other vaginal product during the course of the study, including spermicides
- Agree to sexual abstinence (no vaginal, anal, and receptive oral intercourse) until the elimination of L. jensenii 1153-1666 is confirmed and for 12 hours prior to the final study visit after clearance is confirmed
- For participants with male sexual partners: Agree to use two forms of contraception, condoms plus hormonal or permanent method (intrauterine device [IUD] or tubal ligation) during vaginal intercourse from the time...
- For participants with female sexual partners: Agree to use female condoms during intercourse from the time clearance is established to the Final Visit 30 days after clearance. Use of hormonal or permanent method of...
- Agree to inform their sexual partner about the goals of the study and importance of sexual abstinence (no vaginal, anal, and receptive oral intercourse) and present with their partner at enrollment visit for separate...
- Ability to read and consent in English
- Consent to participate and adhere to all procedures for sexual partners should exposure to L. jensenii 1153-1666 be suspected, including multiple visits at the UCSF Clinical Research Center (CRC)
- Agree to sexual abstinence (no vaginal, anal, and receptive oral intercourse) until the elimination of L. jensenii 1153-1666 is confirmed, and for 12 hours prior to the final study visit after clearance is confirmed
- Urogenital infection, including UTI, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum, HIV-1/2, BV, or vulvovaginal candidiasis
- Abnormal Pap smear result
- Pregnancy or within two months of last pregnancy or lactation
- Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
- Investigational or immune-suppressive drug use within 30 days of enrollment visit or 10 half-lives, or planned during the study
- Intrauterine device insertion or removal, pelvic surgery, cervical cryotherapy, cervical laser or loop electrosurgical procedure, abortion, labioplasty within three months prior to enrollment
- Findings during the pelvic exam at the enrollment visit involving significant deep disruption of the epithelium (e.g., Herpes genitalis lesions)
- Known allergy to any component used in MucoCept-CVN or clindamycin and azithromycin in participant or sexual partner(s), including azithromycin-associated cholestatic jaundice.
- History of transplant surgery, cancer, HIV, diabetes or condition that could facilitate the growth of microorganisms
- Recent history of drug or alcohol abuse
- Unwillingness to abstain from sexual activity during study by participant or sexual partner(s)
- If in a sexual relationship, inability to present with their sexual partner before enrollment
- If in a sexual relationship, having multiple concurrent partners or anonymous partners.
- Any other condition which the study clinician feels would limit the participant's ability to be an appropriate study subject
- History of regional enteritis (Crohn's disease), ulcerative colitis, or "antibiotic-associated" colitis For sexual partners of study participants, the following exclusion criteria apply:
- Known allergy to any component used in MucoCept-CVN or clindamycin and azithromycin, including azithromycin-associated cholestatic jaundice.
- Having multiple concurrent sex partners or anonymous sex partners.
- HIV-1/2 infection
- Any other condition which the study clinician feels would limit the ability of sexual partner(s) to complete the study
- Co-enrollment in clinical trials testing study drugs
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.