GI 0035-0686

Stipend and Dates

Up to $9,500. for study related time and travel (multiple payments)

All dates & times are tentative and may change.	Cohort 1
Day -1 Admit	Mar 27, 2023
Day 8 Discharge	Apr 04
Day 15 Outpatient visit	Apr 11
Day 22 Outpatient visit	Apr 18
Day 29 Outpatient visit	Apr 25
Day 36 Outpatient visit	May 02
Day 43 Outpatient visit	May 09
Day 50 Outpatient visit	May 16
Day 61 Telephone call	May 27

 

Click here to make an appointment for GI 0035-0686

Or call 210-225-5437 for more information

 

Study Criteria

Healthy Non-Smoking Males and Females

Age:  18-45

BMI:  19 to 30 kg/m2

Adequate kidney function (GFR): at least 90 mL/min

 

Study Information

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

Route of Administration: Oral

Washout from previous study: Participants must not be participating in any other study or received an investigational drug within 30 days prior to study dosing for this study.

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 at least an acceptable highly effective contraceptive measure. They must have a negative serum pregnancy test at screening and a negative pregnancy test at the admission visit before enrollment.

 

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)
• 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 initiate use of a hormonal contraceptive greater than 5 days after onset of meses as their birth control method should use an additional backup contraception (eg, condoms) for 7 days or avoid sexual intercourse for 7 days. Hormonally based contraceptive or barrier methods permitted for use in this protocol are as follows:

• Hormonal methods
  • Oral contraceptives (either combined or progesterone only)
  • Injectable progesterone
  • Subdermal contraceptive implant
  • 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

 

Participants assigned female at birth and of childbearing potential must also refrain from egg donation and in vitro fertilization during treatment and until the end of the contraception requirement.

Contraception requirements for participants assigned Male at Birth

No contraception measures are needed.

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.

 

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.