Study of UC-781 Vaginal Microbicide

This study has been completed.
Sponsor:
Collaborators:
Emory University
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00132444
First received: July 11, 2005
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

This study will help determine whether the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use.


Condition Intervention Phase
HIV Infections
Drug: topical vaginal application of UC-781 gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Heterosexual Women and Their Male Partners

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Macroscopic and/or microscopic evidence of cervical, vulvar and/or vaginal epithelial damage, including ulceration, abrasion, severe erythema, and or severe edema. [ Time Frame: with two weeks of administration ] [ Designated as safety issue: Yes ]
  • Symptoms of genital irritation, including burning, itching or soreness [ Time Frame: With 2 weeks of administration ] [ Designated as safety issue: Yes ]
  • Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause [ Time Frame: with 2 weeks of administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and HIV-infected women [ Time Frame: queried after 2 weeks of administation ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
0.25% gel
Drug: topical vaginal application of UC-781 gel
UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
Active Comparator: 2
0.1% gel
Drug: topical vaginal application of UC-781 gel
UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
Placebo Comparator: 3 Drug: topical vaginal application of UC-781 gel
UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For All Females:

  • Ages 18-45 years of age
  • Able to provide written informed consent
  • Normal Pap smear at screening or documentation of such within six months prior
  • Regular monthly menses or amenorrhea due to hormonal contraceptive use
  • Agree to pelvic exam, colposcopy and biopsy (if indicated) per protocol
  • Able/willing to complete Study Diary
  • Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit
  • Agree to apply assigned study gel as required per protocol
  • Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:

    • Insertion of fingers/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
    • Participating in other vaginal microbicide or contraceptive studies

Additional Inclusion Criteria for Stage 1:

  • HIV-uninfected
  • In a monogamous sexually active relationship with one male partner throughout the study
  • Report having vaginal intercourse only with that partner at least two times per week
  • Agree to use study-provided male condoms for each act of vaginal intercourse while taking part in the study
  • Agree to inform male partner about participation

Additional Inclusion Criteria for Stage 2:

  • HIV-infected
  • Sexually abstinent or agree to abstain from sexual intercourse while taking part in the study
  • Under regular medical care for HIV management
  • CD4+ lymphocyte count > 200/mm3 for the last 6 months
  • HIV viral load > 4.0 log10 copies/ml at screening
  • Documentation of prior HIV genotype with one or more mutations conferring resistance to a non-nucleoside reverse transcriptase inhibitor (NNRTI)
  • Not currently on antiretrovirals
  • Willing to provide study staff with access to medical records related to their HIV infection

Inclusion Criteria for Male Partners:

  • Ages 18 years or older
  • Able to give written informed consent
  • Male sexual partners of HIV-uninfected women taking part in Stage 1 of the study

Exclusion Criteria:

Exclusion Criteria for All Females:

  • Are post-menopausal
  • Have had a hysterectomy
  • Clinically significant chronic medical condition (other than HIV) that is considered progressive.
  • History of malignancy, with the exception of basal cell or squamous cell skin cancer
  • Pregnant or planning to become pregnant in the next three months
  • Currently breastfeeding
  • History of sensitivity or allergy to latex or any compound used in this study
  • Have received antibiotics in the 14 days prior to enrollment
  • Have used a spermicide or spermicidally lubricated condom within 7 days prior to enrollment
  • Have been using a hormonal contraceptive method for less than 3 months prior to enrollment
  • Have participated in other microbicide or contraceptive studies in the past three months
  • Grade 3 or higher liver, renal or hematology abnormality, as defined by the Table for Grading the Severity of Adult Adverse Events at screening
  • Have a positive bacterial urine culture
  • Currently have a clinically detectable genital abnormality (i.e. vulvar, vaginal, cervical and/or perineal ulcer or lesions or abnormal Pap smear)
  • In the three months prior to enrollment have had any of the following:

    • An abnormal Pap smear
    • A pregnancy
    • An abortion
    • An intrauterine device (IUD)
    • Breakthrough menstrual bleeding
    • Vaginal bleeding during or following vaginal intercourse
    • Gynecologic surgery
    • Signs consistent with a sexually transmitted disease (STD)
    • Signs of genital trauma
    • Signs of genital tract infection other than asymptomatic bacterial vaginosis (BV)
  • In the six months prior to enrollment have had any of the following:

    • History of treatment for or a diagnosis with a new STD
    • Exchanged sex for money, drugs or gifts
    • Protected (with condoms) penile-vaginal or penile-anal sexual contact with more than 4 partners
    • Unprotected (without condoms) penile-vaginal or penile-anal sexual contact with more than 1 partner
    • A male sexual partner who was diagnosed or treated for an STD (other than HIV)
    • A male sexual partner who has injected drugs
  • Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), crack or other recreational drugs
  • Are currently abusing, or in the last year have abused alcohol.
  • Any other condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Additional Exclusion Criteria for Stage 1:

  • Unprotected (without condoms) or protected (with condoms) penile-vaginal or penile-anal sexual contact with an HIV-infected partner in the past 6 months
  • Unwilling to use study-provided male condoms while on study

Additional Exclusion Criteria for Stage 2:

  • NNRTI mutations in plasma and/or genital secretions at screening
  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: NCT00132444

Locations
United States, Georgia
Hope Clinic of Emory University
Decatur, Georgia, United States, 30030
Sponsors and Collaborators
CONRAD
Emory University
Investigators
Principal Investigator: Kimberly Workowski, MD Emory University
  More Information

No publications provided

Responsible Party: CONRAD
ClinicalTrials.gov Identifier: NCT00132444     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4413
Study First Received: July 11, 2005
Last Updated: January 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
HIV
topical microbicides

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 August 26, 2014