Is NCT07181486 recruiting in San Francisco, CA?

Yes, NCT07181486 is currently recruiting participants at its San Francisco, CA location. This hiv -1 infection clinical trial is actively enrolling qualified participants.

How do I join the hiv -1 infection clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV -1 Infection Clinical Trial in San Francisco, CA

About This HIV -1 Infection Study in San Francisco

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. The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study of MucoCept-CVN is to collect data on safety, colonization, changes to the vaginal microbiota and clearance of the strain with antibiotics. Twelve healthy women will be enrolled and take either one or three doses of MucoCept-CVN or placebo, and a week later will receive antibiotics to clear the Lactobacillus strain. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.

Sponsor: Craig Cohen, MD, MPH

Who Can Participate

Inclusion 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 clearance is established to the Final Visit 30 days after clearance. Use of spermicides is not permitted.

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 contraception (IUD or tubal ligation) is not required.

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 consent procedure for partners Current sexual partners of participants must meet all the following criteria to be enrolled:

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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Francisco?

Yes, this clinical trial (NCT07181486) has an active research site in San Francisco, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV -1 Infection Treatment Options in San Francisco, CA

If you're searching for hiv -1 infection treatment options in San Francisco, CA, this clinical trial (NCT07181486) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Francisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hiv -1 infection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv -1 infection clinical trials near you to find additional studies recruiting in your area.

HIV -1 Infection Clinical Trial in San Francisco, CA

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IRB Approved

No-Cost Care

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