PACTR202011810125237已完成1 期
Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir with and without Levonorgestrel among Women in Western Kenya
nited States Centers for Disease Control and Prevention0 个研究点目标入组 50 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •Female, aged 18-34 years, inclusive
- •General good health (by history and per clinician discretion) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes), uterus, and cervix
- •Not pregnant or planning to become pregnant
- •Pre-screening (Visit 0) HIV risk score =4 (on HIV risk assessment tool developed for women in sub-Saharan Africa (included in Appendix II)
- •Currently having regular menstrual cycles (approximately 24-35 days) OR with a history of having regular menstrual cycles before contraceptive use, by report, and resumed some menstruation or spotting (with biochemical confirmation of ovulation)
- •Willing to undergo Visual Inspection with Lugol’s Iodine (VILI) for cervical abnormalities during pelvic exam at Visit 1
- •oWomen with an abnormal VILI will be linked directly to cervical cancer screening through Papanicolaou smear testing and will not be eligible for enrollment unless cervical cancer screening is negative
- •Willing to abstain from use of vaginal products other than the study product, including tampons (except for during menses) , menstrual cups, vaginally inserted cloths or other materials, spermicides, lubricants, and douches for the whole study
- •Willing to abstain from any vaginal intercourse starting 48 hours before CM collection, as possible, and 48 hours before Visits 4 and 7
- •Vaginal and cervical anatomy that, in the opinion of the clinician, lends itself to easy genital tract sample collection and is absent of vesicles and ulcers
- •No use of hormonal contraceptives within the following periods specified for each type of contraception method:
- •oOral contraceptives (combined or progestin-only), contraceptive patch or contraceptive vaginal ring at least two (2) months prior to Visit 1
- •oLast DMPA injection received at least four (4) months prior to Visit 1 and has resumed re
排除标准
- •Body mass index (BMI) =30 kg/m
- •History of hysterectomy
- •Currently pregnant or within less than three (3) calendar months of the last pregnancy outcome. Note: If recently pregnant, must have had at least two spontaneous menses since pregnancy outcome
- •Currently breastfeeding or having breastfed an infant in the last two (2) months, or planning to breastfeed during the course of the study
- •Contraindication to any study products—LNG, TFV, or excipient ingredients
- •Contraindication to LNG (detailed in Appendix VI and the standard operating procedures (SOP) manual, which is consistent with WHO guidelines http://apps.who.int/iris/bitstream/10665/181468/1/9789241549158_eng.pdf?ua=1
- •In the last three (3) months, diagnosed with or treated for any STI or pelvic inflammatory disease
- •oNote: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six (6) months may be considered for eligibility if pelvic exam shows no vesicles or open lesions.
- •Positive test for HIV-1 (in accordance with national testing algorithm, Appendix IV), syphilis, Trichomonas vaginalis (TV), Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) or HBsAg
- •oNOTE: Women who test positive for HIV-1, syphilis, TV, GC, or CT will be treated for the STI at no cost at the CRC according to the 2015 Kenya National AIDS and STI Control Programme Algorithms for Managing Common STI Syndromes (https://aidsfree.usaid.gov/sites/default/files/hts_policy_kenya_2015.pdf); they will also receive face-to-face counseling, but will not be eligible to take part in the study.
- •Nugent score greater than or equal to 7 or a symptomatic BV clinical diagnosis as defined by Amsel’s criteria
- •oMust have 3 of the 4 signs for a diagnosis of BV using Amsel’s criteria
- •?Discharge, white & homogeneous
- •?Elevated pH, >4.5
- •?Amine odor present
- •?20% clue cells present on wet mount
- •Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)
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