Healthy Female Volunteers for Investigational Drug to Treat HIV-1 Infection
This research study is for the investigational drug that is being developed as a treatment for HIV-1 infection. Route of Administration: Oral
- Day 1 Admission: March 27, 2023
- Day 43: Discharge: May 9, 2023
- 8 hours fasting is required for lab work (only water is allowed)
- If taking medications, bring them to your screening appointment
- Bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver’s license, state issued ID card or passport. You will be required to show this same photo ID at all study visits
- Arrive 30 minutes before your appointment to complete paper work.
Up to $35,125.00 for study related time and travel (multiple payments)
- Healthy Non-Smoking Females
- Age: 18-45
- BMI: 18 to 32 kg/m2
- Adequate kidney function (GFR): greater than 90 mL/min
Washout from previous study: Participants must not have been in any other study or received an investigational drug within 30 days prior to study dosing for this study.
Acceptable Birth Control for Females (if Childbearing): Child bearing Females must use a highly effective contraceptive method during the study beginning at the screening visit until final follow up, after the last dose of investigational drug.
Acceptable methods of birth control for use in this study are:
- Non-hormonal IUD
- Bilateral tubal occlusion (documents required)
- Vasectomized partner (documents required)
- Sexual Abstinence when in line with the preferred and usual lifestyle
Females in the following categories are considered non-childbearing:
- Documented hysterectomy (removal of uterus), bilateral salpingectomy (removal of both Fallopian tubes) or bilateral oophorectomy (removal of both ovaries)
- Postmenopausal when younger than 54 years of age with amenorrhea of at least 12 months if FHS level is in the postmenopausal range and not using hormonal contraception or hormone replacement therapy.
Unacceptable Birth Control Methods include Hormonal Contraception, periodic abstinence, withdrawal, spermicides only and lactational amenorrhea method. A female condom and a male condom should not be used together.
Females of childbearing potential must also refrain from egg donation and in vitro fertilization during treatment and until final follow up, after the last dose of investigational drug.