Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

NCT03960645 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: GS-US-380-53102021-001073-23
• Study Type: interventional
• Target: 62
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)

  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

• PK Parameter: AUClast of BIC, FTC, and TAF

  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

• PK Parameter: Cmax of BIC, FTC, and TAF

  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

• PK Parameter: Ctau of BIC and FTC

  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

• PK Parameter: Clast of BIC, FTC, and TAF

  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

Study Arms (2)

B/F/TAF

EXPERIMENTAL

Pregnant women participants will receive fixed dose combination (FDC) tablet of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).

Drug: B/F/TAF

Neonates

NO INTERVENTION

Neonates who will be born to women participants in the study will be followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates that participate in the study will be treated with the study drug.

Interventions

B/F/TAF DRUG

50/200/25 mg FDC tablet administered orally once daily without regard to food.

Also known as: GS-9883/F/TAF, Biktarvy®, BVY

B/F/TAF

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (8)

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

Triple O Research Institute, P.A.

West Palm Beach, Florida, 33407, United States

Location

Instituto Dominicano de Estudios Virologics (IDEV)

Santo Domingo, 10103, Dominican Republic

Location

Faculty of Medicine Siriraj Hospital

Bangkok Noi, 10700, Thailand

Location

Faculty of Medicine-Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, 11000, Thailand

Location

Research Institute for Health Sciences, Chiang Mai University

Nonthaburi, 50200, Thailand

Location

Thai Red Cross AIDS Research Centre

Pathumwan, 10330, Thailand

Location

Related Publications (1)

• Zhang H, Hindman JT, Lin L, Davis M, Shang J, Xiao D, Avihingsanon A, Arora P, Palaparthy R, Girish S, Marathe DD. A study of the pharmacokinetics, safety, and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed pregnant women with HIV. AIDS. 2024 Jan 1;38(1):F1-F9. doi: 10.1097/QAD.0000000000003783. Epub 2023 Nov 22.

  PMID: 37939141 DERIVED

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study model 'single group' is selected as the Neonates group was only followed up but not treated.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: June 28, 2019
• Primary Completion: July 21, 2022
• Study Completion: August 18, 2022
• Last Updated: June 14, 2024
• Results First Posted: May 28, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (2); TH (5); DO (1)