Stipend and Dates

Up to $16,812.50 for study related time and travel (multiple payments)

Note: Dates and time are tentative and may change. The first cohort is filled before patients are placed in the next cohort. Cohort 3
Day -1 Admit Jan 08, 2023
Day 15 Discharge (a payment within 10 business days of completion) Jan 23, 2023
Day 17 Outpatient Visit Jan 25
Day 20 Outpatient Visit Jan 28
Day 24 Outpatient Visit Feb 01
Day 28 Outpatient Visit Feb 05
Day 32 Outpatient Visit Feb 09
Day 36 Outpatient Visit Feb 13
Day 40 Outpatient Visit Feb 17
Day 45 Outpatient Visit (a payment within 10 business days of completion) Feb 22
Day 50 Outpatient Visit Feb 27
Day 60 Outpatient Visit Mar 09
Day 70 End of study visit (a payment within 10 business days of completion) Mar 19

 

Click here to make and 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 in the following categories are considered non-childbearing:

  • bilateral salpingectomy (removal of both Fallopian tubes)
  • 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.

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.
Reference
GI 22630-22630X SAD
Name
Healthy Females Only
Gender
Female
Payment amount
Up to 16,812.50
Age
18 - 45
Smoking
Non-smokers