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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Placebo gel
Drug: UC 781
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: June 2007
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1
UC 781 0.1% carbomer gel
Drug: UC 781
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
Experimental: 2
UC 781 0.25% carbomer gel
Drug: UC 781
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
Placebo Comparator: 3
Placebo vaginal gel
Drug: Placebo gel
HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446979

Locations
Thailand
Chiang Rai Health Club
Chiang Rai, Thailand, 57000
Sponsors and Collaborators
Ministry of Health, Thailand
CONRAD
Investigators
Principal Investigator: Sara J Whitehead, MD, MPH Centers for Disease Control and Prevention
Principal Investigator: Chitlada Utaipiboon, MD Thailand MOPH - U.S. CDC Collaboration
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00446979     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-4744, MOPH 109/2548
Study First Received: March 12, 2007
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
Microbicides
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014