Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms

Launched by CONRAD · Oct 5, 2015

Keywords

ClinConnect Summary

This is a Phase I, non-randomized, open label study in healthy, non-pregnant, HIV negative women, who are not at risk of pregnancy, and are at low risk for STIs (sexually transmitted infections). Participants will be assigned to use one of four placebo products: IVR (intravaginal ring) (approximately 20 participants), and vaginal insert, film or HEC universal placebo gel (approximately 10 participants each). Each woman will provide pre-product use vaginal swabs. Participants assigned to vaginal insert, film or gel will use products with and without timed intercourse with their male partner ...

Gender

FEMALE

Eligibility criteria

• Volunteers must meet all of the following criteria prior to genital sampling at Visit 2:
• • Age 18 to 50 years, inclusive
• • General good health (by volunteer history and per investigator judgment) 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)
• • History of Pap smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at V1
• • Willing to give voluntary consent and sign an informed consent form
• • Willing and able to comply with protocol requirements
• * Protected from pregnancy by:
• • hysterectomy
• • reliable methods of contraception other than male or female condoms, contraceptive IVR or male partner's vasectomy
• • abstinence (IVR group only)
• • or in a same sex relationship (IVR group only)
• • For gel, insert or film assigned participants: Willing to engage in intercourse with a male sexual partner without the use of male or female condoms as required in the protocol
• * For gel, insert or film assigned participants: In a mutually monogamous relationship with a male partner who:
• • Is at least 18 years old
• • Is not known to be HIV positive
• • Has no known risk for STIs
• • Has not undergone a vasectomy
• • Is not known to have azoospermia
• • Is willing and able to comply with protocol requirements regarding sexual activity/ abstinence
• • Can engage with the participant in vaginal intercourse without condoms, as specified in the protocol 8.2. Exclusion Criteria
• Volunteers must not meet any of the following criteria prior to genital sampling at Visit 2:
• • Currently pregnant
• • Currently breastfeeding or planning to breastfeed during the course of the study
• • History of sensitivity/allergy to any component of the vaginal products for either the volunteer or her sexual partner, as applicable
• • Use of vaginal douches, creams or gels, other than the study product, at any time during the study, beginning 7 days prior to V2
• • In the last six months, either the volunteer or her sexual partner (as applicable) diagnosed with or treated for any STI. Note: Women with a history of genital herpes who have been asymptomatic for at least six months may be considered for eligibility
• • Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis or HIV
• • Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)
• • Known current drug or alcohol abuse which could impact study compliance
• • Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
• • Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her sexual partner (as applicable) which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data