A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Safety (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal flora;
研究概览
简要总结
The primary aims of the study were to assess the safety and acceptability of Carraguard ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather preliminary data on Carraguard's effectiveness in preventing male-to-female transmission of HIV.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; that women would find Carraguard acceptable. The study was not powered to determine effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 efficacy trial.
详细描述
Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a triple-masked, randomized, placebo-controlled trial fielded in two sites in South Africa. The primary aims of the study were to assess Carraguard's safety (toxicity) - including signs of irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings - when applied vaginally for durations of 6-12 months, and to evaluate several dimensions of the acceptability of Carraguard and placebo products. Secondary aims were to investigate whether study participants using Carraguard had lower rates of HIV seroconversion or other sexually transmitted infections (including C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum) than the placebo (methyl cellulose gel). In addition, when it began, this trial was the first to explore the feasibility of large-scale microbicides testing in a non-sex worker population. Last, the trial gauged women's reactions to using a non-contraceptive product (in vitro testing had shown that Carraguard has no contraceptive effect), as well as potential use-dynamics in communities where drying agents and other traditional vaginal products are used with high frequency.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In good health as determined by medical history, physical examination and results of laboratory screening tests for RTIs
- •Aged 18 years or older
- •Resident in the area for at least one year and planning to stay for at least 12 months
- •HIV-seronegative at screening
- •Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations), and,
- •Able to give informed consent
排除标准
- •Pregnant or desire to become pregnant during the trial
- •Delivered or aborted a pregnancy within the six weeks prior to screening
- •History of surgery on external genitalia, vagina or cervix in the six weeks prior to screening
- •Recent history of non-menstrual vaginal bleeding with intercourse
- •Clinically detectable genital abnormality (including presence of warts, or a structural or congenital abnormality)
- •Clinical suspicion of a RTI (defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STI test result)
- •Abnormal Pap smear
- •History of sensitivity/allergy to latex
- •Participating in another trial of a vaginal product
- •Reported injection of recreational drugs
结局指标
主要结局
Safety (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal flora;
Compliance: collection of applicators and interview(monthly)
Acceptability: interview (quarterly)
次要结局
- Preliminary effectiveness: Swabs taken to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis (monthly) and blood drawn for syphilis and HIV testing (Month 1 and quarterly thereafter).