Healthy Volunteers for Investigational Drug to Treat HIV-1 Infection
Not yet recruiting
This clinical study is for the investigational drug that is being studied as a treatment for HIV-1 infection. Route of Administration: Oral
Day 1 Admission: April 5, 2023
Day 15 Discharge: April 20, 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 $15,500. for study related time and travel (multiple payments)
- Healthy Non-Smoking Males and Females
- Age: 18-45
- BMI: 19 to 30 kg/m2
- Adequate kidney function (GFR): at least 90 mL/min
Contraception requirements for participants assigned Female at Birth and of Childbearing potential
Participants assigned female at birth are considered to be in a postmenopausal state when they are at least 54 years of age with cessation of previously occurring menses for at least 12 months without an alternative cause. In addition, participants assigned female at birth younger than 54 years with amenorrhea of at least 12 months also may be considered postmenopausal if their FSH level is in the postmenopausal range and they are not using hormonal contraception or hormonal replacement therapy. Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy in a participant assigned female at birth of any age. Documentation is required.
The inclusion of participant assigned female at birth and of childbearing potential requires the use of highly effective contraceptive measures with a failure rate of less than 1% per year. They must have a negative serum pregnancy test at screening and a negative pregnancy test at the admission visit before enrollment. Pregnancy tests will be performed at monthly intervals thereafter until the end of contraception requirement.
Participants assigned female at birth and of childbearing potential must agree to 1 of the following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable method of contraception only when it is in line with the participant’s preferred and usual lifestyle.
Or Consistent and correct use of 1 of the following methods of birth control listed below:
- Hormonal or nonhormonal intrauterine device (IUD)
- Subdermal contraceptive implant
- Bilateral tubal occlusion (upon medical assessment of surgical success)
- Vasectomy in the partner assigned male at birth (upon medical assessment of surgical success)
Or participants assigned female at birth and of childbearing potential who wish to use a hormonally based method must use it in conjunction with a barrier method, preferably a male condom. Hormonal methods are restricted to those associated with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted for use in this protocol are as follows:
- Hormonal methods (each method must be used with a barrier method, preferably male condom
- Oral contraceptives (either combined or progesterone only)
- Injectable progesterone
- Transdermal contraceptive patch
- Contraceptive vaginal ring
- Barrier methods (each method must be used with a hormonal method)
- Male condom (with or without spermicide)
- Female condom (with or without spermicide)
- Diaphragm with spermicide
- Cervical cap with spermicide
- Sponge with spermicide
Contraception requirements for participants assigned Male at Birth
A participant assigned male at birth with a partner assigned female at birth and of childbearing potential must use condoms during treatment and until 113 days after the first dose of the study drug. If the partner assigned female at birth and of childbearing potential is not pregnant, additional contraception recommendations should also be considered.
Participants assigned male at birth must also refrain from sperm donation and cryopreservation of sperm cells during treatment and until the end of contraception requirement.
Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method. A female condom and a male condom should not be used together.