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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03960645
Other study ID # GS-US-380-5310
Secondary ID 2021-001073-23
Status Completed
Phase Phase 1
First received
Last updated
Start date June 28, 2019
Est. completion date August 18, 2022

Study information

Verified date December 2023
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 18, 2022
Est. primary completion date July 21, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Key Inclusion Criteria: - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - With singleton pregnancy, at least 12 weeks but not more than 31 weeks pregnant at the time of screening - Agree not to breastfeed for the duration of the study - Currently on a stable antiretroviral regimen for = 6 months preceding the screening visit - Documented plasma HIV-1 ribonucleic acid (RNA) levels of < 50 copies/mL for = 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at the screening visit - Have no documented or suspected resistance to FTC, Tenofovir (TFV), or integrase strand-transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R or M184V/I - Have a normal ultrasound, completed locally prior to the Day 1 visit, with no evidence of any fetal malformation or structural abnormality affecting either fetus or placenta - Normal maternal alfa-fetoprotein level at the screening visit Key Exclusion Criteria: - Have chronic hepatitis B virus (HBV) - Have active hepatitis C virus (HCV) infection - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food.

Locations

Country Name City State
Dominican Republic Instituto Dominicano de Estudios Virologics (IDEV) Santo Domingo
Thailand Faculty of Medicine Siriraj Hospital Bangkok Noi
Thailand Faculty of Medicine-Khon Kaen University Khon Kaen
Thailand Bamrasnaradura Infectious Diseases Institute Mueang Nonthaburi
Thailand Research Institute for Health Sciences, Chiang Mai University Mueang Nonthaburi
Thailand Thai Red Cross AIDS Research Centre Pathumwan
United States Midway Immunology and Research Center Fort Pierce Florida
United States Triple O Research Institute, P.A. West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Dominican Republic,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC) AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF) AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: AUClast of BIC, FTC, and TAF AUClast is defined as the concentration of drug from time zero to the last observable concentration. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: Cmax of BIC, FTC, and TAF Cmax is defined as the maximum observed concentration of drug during the dosing interval. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: Ctau of BIC and FTC Ctau is defined as the observed drug concentration at the end of the dosing interval. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: Clast of BIC, FTC, and TAF Clast is defined as the last observable concentration of drug. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: Tmax of BIC, FTC, and TAF Tmax is defined as the time (observed time point) of Cmax. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: t1/2 of BIC, FTC, and TAF t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: CLss/F of BIC, FTC, and TAF CLss/F is defined as the apparent steady-state oral clearance following administration of the drug. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: Vz/F of BIC, FTC, and TAF Vz/F is defined as the apparent volume of distribution of the drug. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary PK Parameter: ?z of BIC, FTC, and TAF ?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Secondary Percentage of Participants With HIV-1 RNA < 50 Copies/mL at the Time of Delivery Using the Missing = Excluded Approach in B/F/TAF Group The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of delivery was analyzed in B/F/TAF group using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). At time of delivery
Secondary Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Birth Using the Missing = Excluded Approach in Neonates The percentage of participants with HIV-1 RNA < 50 copies/mL at the time of birth was analyzed in neonates using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). At birth
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