GI 22630-22630x MAD c13 & 14

Stipend and Dates

Up to $15,000. for study related time and travel (multiple payments)

All dates & times are tentative and may change.	Cohort 14B
Day -1 Admit	Oct 05, 2023
Day 15 Discharge	Oct 20, 2023
Day 17 Outpatient visit	Oct 22
Day 20 Outpatient visit	Oct 25
Day 24 Outpatient visit	Oct 29
Day 28 Outpatient visit	Nov 02
Day 32 Outpatient visit	Nov 06
Day 36 Outpatient visit	Nov 10
Day 40 Outpatient visit	Nov 14
Day 45 Outpatient visit	Nov 19
Day 50 End of study visit	Nov 24

 

Click here to make an appointment for GI 22630-22630x Females Only

Or call 210-225-5437 for more information

 

Study Criteria

Healthy Non-Smoking Females

Age:  18-45

BMI:  18 to 32 kg/m2

Adequate kidney function (GFR): greater than 90 mL/min

 

Study Information

Indication: The investigational drug is being developed as a treatment for HIV-1 infection.

Route of Administration: Oral

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 of childbearing potential must also refrain from egg donation and in vitro fertilization during treatment and until the end f contraception requirement.

Unacceptable Birth Control Methods include 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.

 

Study Reminders

• 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.