Clinical trial NCT00446979: Safety Study of UC-781 Vaginal Microbicide
Official title: Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Women and Acceptability in Their Male Partners,Chiang Rai, Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Microbicides
HIV seronegativity
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Ministry of Health, Thailand
name: CONRAD
First posted: 2007-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.


Eligibility criteria: Inclusion Criteria for women:

* Age 18-50 years old
* Regular menses
* HIV-1 seronegative at screening
* Normal Pap smear at screening or documented normal Pap smear within six months prior to screening
* No evidence of reproductive tract infection (RTI)
* Willing and able to comply with study procedures, including pelvic exams, colposcopy, maintaining a study coital and symptom log, and applying assigned study gel per protocol
* Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit
* Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:

  * Insertion of fingers and other objects into the vagina
  * Receiving oral sex
  * Receiving anal sex
  * Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
  * Using vaginal products other than the study gels, including douches, lubricants, or feminine hygiene products
* In a monogamous sexually active relationship with one male partner
* Report having vaginal intercourse only with that partner at least two times per week
* No other reported partner in the prior six months and no plan to have another partner for the duration of the study
* Agree to use condoms for each act of vaginal intercourse during participation in the study
* Their male partner is informed and also consents to participate in the study
* Willing to have male partner informed and treated if an STD is diagnosed at screening or during the study

Inclusion Criteria for men:

* Age 18 years or older
* HIV-seronegative and free of other STI at screening exam
* One female sexual partner; no other reported partner in the prior six months and no plan to have another partner for the duration of the study
* Willing and able to comply with study procedures, including clinic visits, interviews and acceptability evaluation, and consistent use of condoms during enrollment in the study
* Willing to have female partner informed and treated if an STD is diagnosed at screening or during the study

Exclusion Criteria for women:

* Pregnancy or desire to become pregnant at time of study participation
* Currently breastfeeding
* Delivery or abortion within last eight weeks
* History of any male sexual partner other than current partner in past six months

  - No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including hematology, liver and kidney function
* History of post-coital vaginal bleeding in the past three months
* History of surgery to remove uterus or cervix
* History of surgery on the external genitalia, vaginal, or cervix in the past month
* Clinically significant chronic medical condition that is considered progressive, including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.
* History of sensitivity/allergy to latex
* Existence of a clinically detectable genital abnormality at screening (e.g. ulcer, congenital abnormality, any lesion with mucosal disruption)
* Concurrent participation in another trial of a vaginal product
* Have any other condition that in the opinion of the investigator might interfere with the evaluation of the study objectives

Exclusion Criteria for men:

* History of genital surgery in the past month
* Clinical or laboratory evidence of an STI.
* History of sensitivity/allergy to latex
* History of any sexual partner other than their current partner in the past six months

Primary outcomes:
measure: Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
timeFrame: 2 weeks
measure: Symptoms of irritation
timeFrame: two weeks
measure: Changes in vaginal flora
timeFrame: Two weeks
measure: Assessment of pro-inflammatory cytokines in the genital tract
timeFrame: Two weeks
measure: Other product-related adverse events
timeFrame: Two weeks
Secondary outcomes:
measure: acceptability of UC-781 gel use
timeFrame: Two weeks
measure: systemic absorption of UC-781
timeFrame: Two weeks
measure: anti-HIV activity of genital secretions in the presence of UC-781 gel
timeFrame: Two weeks
Other outcomes:
Locations:
city: Chiang Rai
country: Thailand
facility: Chiang Rai Health Club
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Sara J Whitehead, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Thailand MOPH - U.S. CDC Collaboration
name: Chitlada Utaipiboon, MD
role: PRINCIPAL_INVESTIGATOR
References: