Study of UC-781 Vaginal Microbicide

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 use.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CONRAD
• Collaborators: Centers for Disease Control and Prevention; Emory University
• Treatments: Anti-Infective Agents; UC-781

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