Status:
COMPLETED
Study of UC-781 Vaginal Microbicide
Lead Sponsor:
CONRAD
Collaborating Sponsors:
Emory University
Centers for Disease Control and Prevention
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 u...
Detailed Description
Purpose: To assess the safety and acceptability of vaginal use of 0.1% and 0.25% UC-781 gel in sexually active HIV-uninfected women, and their male partners, and sexually abstinent HIV-infected women ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00132444
Start Date
October 1 2005
End Date
December 1 2008
Last Update
January 7 2010
Active Locations (1)
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1
Hope Clinic of Emory University
Decatur, Georgia, United States, 30030