The purpose of this pharmacokinetic (PK) trial is to evaluate whether the ENG implant, a long-acting birth control method, is tolerable and effective for adults with HIV who are taking long-acting cabotegravir (CAB-LA) and long-acting rilpivirine (RPV-LA). Access to safe and effective birth control for adults with HIV is important because it may result in fewer infants exposed to HIV in the womb or born with HIV. Researchers believe that people of childbearing potential need access to birth control options that do not need to be negotiated with a partner.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Etonogestrel is available as a single, white/off-white, soft, radiopaque, flexible, ethylene vinyl acetate copolymer implant, 4 cm in length and 2 mm in diameter containing 68 mg of etonogestrel. Store at 25°C (77°F); excursions permitted between 15 and 30°C (59-86°F) \[see USP Controlled Room Temperature\]. Avoid storing ENG at temperatures above 30°C (86°F).
ENG PK parameter Area under the concentration-time curve (AUC0-24weeks) based on ENG PK samples obtained from individual participants
AUC for each participant will be calculated from all available ENG concentrations measured over 24 weeks using the linear interpolation version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule uses linear interpolation between untransformed data up through Clast. Assay lower limit of quantification (LLoQ) for ENG is 0.025 ng/mL; values \< LLoQ were imputed as 0 (if pre-dose) or as ½ the LLoQ, 0.0125 ng/mL (if post-dose).
Time frame: PK samples at pre-insertion, and 1, 4, 12 and 24 weeks post implant insertion
ENG PK parameter Area under the concentration-time curve (AUC0-12weeks) based on ENG PK samples obtained from individual participants
AUC for each participant will be calculated from all available ENG concentrations measured over 12 weeks using the linear interpolation version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule uses linear interpolation between untransformed data up through Clast. Assay lower limit of quantification (LLoQ) for ENG was 0.025 ng/mL; values \< LLoQ were imputed as 0 (if pre-dose) or as ½ the LLoQ, 0.0125 ng/mL (if post-dose).
Time frame: PK samples at pre-insertion, and 1, 4, and 12 weeks post implant insertion
Probability of having ENG implant removed due to intolerance before 48 weeks
Probability estimated by method of Kaplan and Meier that censors when ENG implant removed for reasons other than intolerance
Time frame: From insertion of implant to 48 weeks
ENG PK parameter Area under the concentration-time curve (AUC0-48weeks) based on ENG PK samples obtained from individual participants
AUC for each participant will be calculated from all available ENG concentrations measured over 48 weeks using the linear interpolation version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule uses linear interpolation between untransformed data up through Clast. Assay lower limit of quantification (LLoQ) for ENG was 0.025 ng/mL; values \< LLoQ were imputed as 0 (if pre-dose) or as ½ the LLoQ, 0.0125 ng/mL (if post-dose).
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Time frame: PK samples at pre-insertion, and 1, 4, 12, 24, 36 and 48 weeks post implant insertion
ENG total concentration in serum
ENG concentrations in ng/mL measured over 48 weeks. Assay lower limit of quantification (LLoQ) for ENG was 0.025 ng/mL; values \< LLoQ were imputed as ½ the LLoQ, 0.0125 ng/mL.
Time frame: PK samples at pre-insertion, and 1, 4, 12, 24, 36 and 48 weeks post implant insertion