NCT00132444已完成1 期
Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Heterosexual Women and Their Male Partners
CONRAD1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Macroscopic and/or microscopic evidence of cervical, vulvar and/or vaginal epithelial damage, including ulceration, abrasion, severe erythema, and or severe edema.
研究概览
简要总结
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.
详细描述
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
Design: Single-center, phase I randomized, double-blind, controlled trial with 14 days of twice-daily product or control gel exposure
Study population: Sexually active, HIV-uninfected women at low-risk for HIV and their male partners; sexually-abstinent HIV-infected women; all age 18-45
Size: 36 sexually active HIV-uninfected women and up to 36 of their male partners; 18 sexually abstinent HIV-infected women
Treatment regimen:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Active Comparator
0.25% gel
干预措施: topical vaginal application of UC-781 gel (Drug)
2
Active Comparator
0.1% gel
干预措施: topical vaginal application of UC-781 gel (Drug)
3
Placebo Comparator
干预措施: topical vaginal application of UC-781 gel (Drug)
结局指标
主要结局
Macroscopic and/or microscopic evidence of cervical, vulvar and/or vaginal epithelial damage, including ulceration, abrasion, severe erythema, and or severe edema.
时间窗: with two weeks of administration
Symptoms of genital irritation, including burning, itching or soreness
时间窗: With 2 weeks of administration
Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause
时间窗: with 2 weeks of administration
次要结局
- Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and HIV-infected women(queried after 2 weeks of administation)
研究者
研究点 (1)
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