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Safety Study of UC-781 Vaginal Microbicide

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Thailand
CONRAD
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00446979
First received: March 12, 2007
Last updated: April 18, 2013
Last verified: April 2013

March 12, 2007
April 18, 2013
June 2007
Not Provided
  • Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Symptoms of irritation [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
  • Changes in vaginal flora [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
  • Assessment of pro-inflammatory cytokines in the genital tract [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
  • Other product-related adverse events [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
  • Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
  • Symptoms of irritation
  • Changes in vaginal flora
  • Assessment of pro-inflammatory cytokines in the genital tract
  • Other product-related adverse events
Complete list of historical versions of study NCT00446979 on ClinicalTrials.gov Archive Site
  • acceptability of UC-781 gel use [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • systemic absorption of UC-781 [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • anti-HIV activity of genital secretions in the presence of UC-781 gel [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • acceptability of UC-781 gel use
  • systemic absorption of UC-781
  • anti-HIV activity of genital secretions in the presence of UC-781 gel
Not Provided
Not Provided
 
Safety Study of UC-781 Vaginal Microbicide
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Drug: Placebo gel
    HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks
  • Drug: UC 781
    UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
  • Experimental: 1
    UC 781 0.1% carbomer gel
    Intervention: Drug: UC 781
  • Experimental: 2
    UC 781 0.25% carbomer gel
    Intervention: Drug: UC 781
  • Placebo Comparator: 3
    Placebo vaginal gel
    Intervention: Drug: Placebo gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
October 2007
Not Provided

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00446979
CDC-NCHHSTP-4744, MOPH 109/2548
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • Ministry of Health, Thailand
  • CONRAD
Principal Investigator: Sara J Whitehead, MD, MPH Centers for Disease Control and Prevention
Principal Investigator: Chitlada Utaipiboon, MD Thailand MOPH - U.S. CDC Collaboration
Centers for Disease Control and Prevention
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP