HIV-1-infection Clinical Trial
Official title:
A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
Verified date | December 2023 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Dominican Republic, Thailand,
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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