Human Immunodeficiency Virus (HIV-1) Infections MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
F
Other descriptive name: EMTRICITABINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: TENOFOVIR ALAFENAMIDE
CAS Number: 379270-37-8
Curr
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria to be eligible for participation in this study. 1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2) Female participants of age = 18 to 5 × ULN will remain eligible if serum lipase is = 5 × ULN) 15) Participants of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-heterosexually active or practice sexual abstinence (as defined in Appendix 6) during the post-partum period of the study, and for 7 days following the last dose of study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants who meet any of the following exclusion criteria are not to be enrolled in this study. 1) Have chronic hepatitis B virus (HBV) as determined by either: a) Positive HBV surface antigen (HBsAg) at the Screening Visit b) Negative HBV surface antigen, negative HBV surface antibody, positive HBV core antibody and quantifiable HBV DNA (HBV DNA = 20 IU/mL) at the Screening Visit 2) Have active hepatitis C virus (HCV) infection a) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable 3) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to Appendix 5) 4) Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) 5) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) 6) Malignancy within 5 years of screening other than cutaneous Kaposi’s sarcoma, completely resected non-melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed. 7) Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance 8) Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1 9) Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial 10) Any other clinical condition, including pregnancy complications such as gestational diabetes or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements 11) Active tuberculosis infection 12) Known hypersensitivity to B/F/TAF, their metabolites, or formulation excipient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the steady state pharmacokinetics (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 the second and third trimesters of pregnancy;Secondary Objective: • To evaluate the steady state PK of emtricitabine (FTC) and TAF in the second and third trimesters of pregnancy • To evaluate maintenance of HIV-1 virologic suppression in pregnant women receiving the B/F/TAF FDC during the second and/or third trimesters;Primary end point(s): The primary endpoint is the PK parameter AUCtau of BIC during the second and/or third trimesters through post-partum.;Timepoint(s) of evaluation of this end point: Intensive PK (iPK) visits during second and/or third trimesters through post-partum with sample collection timepoints as follows: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The PK parameter AUCtau for FTC and TAF, and PK parameters AUClast, Cmax, Ctau, Clast, Tmax, T1/2, CL/F, Vz/F and ?z for BIC, FTC and TAF, as applicable • The proportion of participants with plasma HIV-1 RNA < 50 copies/mL at the time of delivery by missing = excluded approach.;Timepoint(s) of evaluation of this end point: - Intensive PK (iPK) visits during second and/or third trimesters through post-partum with sample collection timepoints as follows: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose - At the delivery visit | — |
Countries
Dominican Republic, Puerto Rico, Thailand, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed