Phase 1
Completed N=62
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
Source: ClinicalTrials.gov NCT03960645 ↗Enrolled (actual)
62
Serious AEs
17.7%
Results posted
May 2024
Primary outcomePrimary: Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC) — 62772.2; 60163.4; 134820.3; 148251.6 hours*nanograms per milliliter (h*ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC) |
62772.2; 60163.4; 134820.3; 148251.6 | — |
| SECONDARY PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF) |
10263.8; 10435.2; 16277.5; 15308.5; 235.5; 212.1 | — |
| SECONDARY PK Parameter: AUClast of BIC, FTC, and TAF |
63187.5; 60145.3; 135058.9; 148265.3; 10258.5; 10434.2 | — |
| SECONDARY PK Parameter: Cmax of BIC, FTC, and TAF |
5819.0; 5374.7; 9765.5; 11025.3; 2639.1; 2586.0 | — |
| SECONDARY PK Parameter: Ctau of BIC and FTC |
1046.4; 1072.4; 3530.3; 3641.9; 59.8; 51.4 | — |
| SECONDARY PK Parameter: Clast of BIC, FTC, and TAF |
1141.10; 1075.13; 3535.48; 3641.88; 75.08; 51.65 | — |
| SECONDARY PK Parameter: Tmax of BIC, FTC, and TAF |
2.00; 2.00; 1.50; 1.50; 1.50; 1.50 | — |
| SECONDARY PK Parameter: t1/2 of BIC, FTC, and TAF |
9.09; 9.91; 18.24; 17.27; 6.43; 6.41 | — |
| SECONDARY PK Parameter: CLss/F of BIC, FTC, and TAF |
911.78; 902.47; 399.02; 362.40; 20228.02; 19975.85 | — |
| SECONDARY PK Parameter: Vz/F of BIC, FTC, and TAF |
11896.24; 13406.77; 10348.47; 8692.59; 181767.32; 184791.79 | — |
| SECONDARY PK Parameter: λz of BIC, FTC, and TAF |
0.077; 0.068; 0.040; 0.043; 0.113; 0.112 | — |
| 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 |
100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Birth Using the Missing = Excluded Approach in Neonates |
100.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03960645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.