Will switching HIV-1-infected patients who have drug resistant HIV and stable on a regimen based on a protease inhibitor to another regimen based on the integrase inhibitor bictegravir be as equally effective?
- Conditions
- Human Immunodeficiency VirusMedDRA version: 20.1Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 100000004862Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2018-004732-30-GB
- Lead Sponsor
- niversity of Sussex
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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 <50 copies/mL within the previous 6 months and at screening
Eligible drug resistance mutations in historical genotype include the following:
oM184V/I with or without any nucleoside analogue mutation (e.g. L74I/V, Y115F, K70E/G/Q/T/N/S)
oM184V/I alone
oUp to 2 TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I
oAny of the above with or without NNRTI mutations
No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI)
No known INSTI mutations
Must have historical genotype
Estimated GFR = 50 mL/min (Cockcroft-Gault formula)
Have the following laboratory values at screening within 30 days prior to baseline
a) Alkaline phosphatase = 3.0 x upper limit of normal (ULN)
b) AST and ALT = 5.0 x ULN
c) Hemoglobin =9.0 g/dL (if female) or =10.0 g/dL (if male).
Provides written, informed consent to participate
Is willing to comply with the protocol requirements
If female and of child bearing potential, is using effective birth control methods (as agreed by the investigator) and willing to continue practicing these birth control measures during the trial and for at least 30 days after the end of the trial.
If male, and sexually-active with female partners of child bearing potential, is using effective barrier contraception, and willing to continue using this during the trial and for at least 30 days after the end of the trial.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion under drug resistance mutations include:
oPresence of any of the following mutations: K65R/N/E
oPresence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y
othree 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method