Human Immunodeficiency Virus MedDRA version: 20.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Bictegravir
Product Name: Bictegravir
Pharmaceutical Form: Tablet
INN or Proposed INN: bictegravir
CAS Number: 1611493-60-7
Other descriptive name: Biktarvy
Concentration unit: mg milligra
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years and above Any nadir CD4 count and baseline VL On a bPI-based ART regimen with at least one documented HIV-1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Exclusion under drug resistance mutations include: o Presence of any of the following mutations: K65R/N/E o Presence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y o three or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) An opportunistic illness within the 30 days prior to screening Active tuberculosis infection 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) Current alcohol or substance use judged by the Investigator to potentially interfere with subjects’ adherence to study procedure. A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 (except if the parenteral therapy is for syphilis infection) Any other clinical condition or prior therapy that will, in the opinion of the investigator, make the subject ineligible Any known allergies to the excipients of B/F/TAF FDC Females who are pregnant (as confirmed by positive urine pregnancy test) Females who are breastfeeding Women of child bearing age not using any reliable form of contraception (e.g. intrauterine device/intrauterine system, long-acting contraceptive injection, in addition to barrier methods) Acute hepatitis in the 30 days prior to study entry, anyone with HCV who is likely to need direct acting antivirals in study Any concomitant medications that cannot be administered with TAF (i.e strong inducers of p-glycoprotein) or bictegravir (dofetilide, rifampins)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Switching HIV-positive individuals whose virus has selected drug resistance associated mutations and are virologically suppressed (this means the drugs are still working and HIV is under the level of detection in the blood) on a boosted protease inhibitor-based antiretroviral drug regimen to Biktarvy [bictegravir (B)/emtricitabine (F)/tenofovir alafenamide] (TAF) single tablet regimen will maintain virological efficacy (HIV-1 RNA <50 copies/mL) over 24 weeks.;Secondary Objective: •To estimate proportion of patients with HIV-1 RNA <50 copies/mL at week 48 using pure virological response (PVR) • To estimate proportion of patients with HIV-1 RNA <50 copies/mL at weeks 24 and 48 using PVR in those with any archived resistance detected in proviral DNA •To evaluate the emergence of new resistance mutations in participants with two consecutive viral load =50 copies/mL measured 2-3 weeks apart. •To determine the safety and tolerability of B/F/TAF single tablet regimen in participants switching from boosted Protease Inhibitor-based regimens over 48 weeks •To evaluate the between group change from baseline in patient reported outcomes at weeks 24 and 48 •To estimate the between group mean percentage change from baseline in serum lipid concentrations at weeks 24 and 48 •To estimate the between arm mean percentage change from baseline in HBA1c at weeks 24 and 48 •To estimate the between arm mean percentage change from baseline in weight and BMI at weeks 2;Primary end point(s): Proportions of individuals with HIV RNA <50 copies/mL at 24 weeks will be estimated using pure virologic response (PVR). The percentage of participants with PVR for HIV-1 RNA cut-off at 50 copies/mL at Week 24 will be summarized. PVR will be assessed as follows: •On study treatment •No confirmed virologic rebound defined as: oHIV RNA = 50 copies/mL on 2 consecutive visits oHIV-1 RNA = 50 copies/mL during study followed by premature discontinuation Discontinuation prior to we | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To estimate proportion of patients with HIV-1 RNA <50 copies/mL at week 48 using pure virological response (PVR) To estimate proportion of patients with HIV-1 RNA <50 copies/mL at weeks 24 and 48 using PVR in those with any archived resistance detected in proviral DNA To evaluate the emergence of new resistance mutations in participants with two consecutive viral load =50 copies/mL measured 2-3 weeks apart. To determine the safety and tolerability of B/F/TAF single tablet regimen in participants switching from boosted Protease Inhibitor-based regimens over 48 weeks To evaluate the between group change from baseline in patient reported outcomes at weeks 24 and 48 To estimate the between group mean percentage change from baseline in serum lipid concentrations at weeks 24 and 48 To estimate the between arm mean percentage change from baseline in HBA1c at weeks 24 and 48 To estimate the between arm mean percentage change from baseline in weight and BMI at weeks 24 and 48;Timepoint(s) of evaluation of this end point: Weeks 24 and 48 | — |
Countries
United Kingdom
Contacts
Public ContactNicky Perry
University of Sussex
Outcome results
None listed