Human Immunodeficiency Virus (HIV) infection MedDRA version: 20.0 Level: LLT Classification code 10020441 Term: Human immunodeficiency virus infection, unspecified System Organ Class: 100000004862
Conditions
Sponsors
Chelsea and Westminster Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is male or female aged 18 years or over. 2. Confirmed diagnosis of HIV-1 as per local clinic definition less than 14 days before day treatment is to be initiated. 3. Is capable of giving informed consent. 4. Is willing to comply with the protocol requirements 5. A female may be eligible to enter and participate in the study if she: a. is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and = 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, b. is of child-bearing potential with a negative pregnancy test at Screening (& baseline visit) and agrees to use one of the methods of contraception to avoid pregnancy indicated in Appendix 4 during the study and for a period of 12 weeks after the study. 6. Men who have partners who are women of childbearing potential (WOCBP – definition in Appendix 4) must be using an adequate method of contraception as listed in Appendix 4 to avoid pregnancy in their partner throughout the study and for a period of at least 12 weeks after the study; 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 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Infected by HIV-2 2. On PEP 3. Use of medications that are known to interact with either treatment B or S. Contraindications given appendix 4 of protocol and full information on drug-drug interactions given in SmPCs. 4. Hypersensitivity to active substance or excipient of B or S as listed in SmPCs. 5. Unstable health conditions that according to the opinion of the Investigator suggest the individual should not take part in the trial (including unstable liver diseases, possible opportunistic infections, etc) or health condition listed in contraindications to B and S in appendix 4 of protocol. 6. Women planning pregnancy or who are pregnant or breast feeding. (NB: See protocol section 4.4; Withdrawal Criteria and Section 10.4; Collection and Follow up of Adverse Events if pregnancy does occur in a trial subject) 7. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomisation. 8. Known acute or chronic viral hepatitis including, but not limited to, A, B, or C 9. Any investigational drug within 30 days prior to the trial drug administration 10. Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare virological response in newly diagnosed HIV patients at week 12 when administering TAF/FTC/BIC (Biktarvy) versus TAF/FTC/DRV/c (Symtuza) in the context of 'test and treat'.;Secondary Objective: Secondary objectives: - To assess absolute efficacy of Biktarvy and Symtuza in achieving viral suppression in newly diagnosed HIV patients - To investigate the safety and tolerability of Symtuza and Biktarvy - To investigate changes over time in CD4 count and CD4:CD8 ratio in participants treated with Biktarvy and Symtuza. - To assess and compare participant wellbeing as recorded in patient recorded outcomes measures for those receiving Biktarvy and Symtuza - To investigate viral resistance including in cases of virological failure. In cases of virological failure drug level may be assessed to investigate whether concentrations were adequate. - To assess frequency of newly diagnosed patients taking medication with known drug-drug interactions with Symtuza and Biktarvy and the difference between the two treatments. - To assess the proportion of newly diagnosed HIV patients who remain under regular treatment for their infection after one year. - To record from data cohort what c;Primary end point(s): Time-weighted average change from baseline to week 12 in log10 HIV RNA level recorded in viral load assays from initiation of treatment in newly diagnosed HIV patients.;Timepoint(s) of evaluation of this end point: 12 weeks from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Samples and data for secondary and exploratory endpoints will be taken at visits on week 2, 4, 12, 24, 48. Data and samples for patient recorded outcome measures, sensitive viral load tests and platelet and endothelial markers will only be collected on weeks 24 and 48.;Secondary end point(s): - Absolute efficacy of study treatments: Proportion of patients treated with Biktarvy and Symtuza with HIV viral load less than 20 copies/ml and less than 50 copies/ml at week 2, 4, 12, 24, and 48 - Safety and tolerability: • Occurrence of changes in laboratory parameters at week 48 from baseline • Occurrence of adverse events, severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatments. - Changes in CD4 count and CD4:CD8 ratio during study - Scores from Patient recorded outcome measures at weeks 24 and 48: • Pittsburgh sleep questionnaire • Wellness thermometer • PHQ-9 • GAD-7 - Occurrences and details of viral resistance in study participants - Occurrences of plasma drug levels found to below effective concentrations in cases of virological failure - Frequency of newly diagnosed HIV patients currently on medication with known drug-drug interaction with Bikarvy and with Symtuza - Proportion of newly diagnosed HIV patients for which it is possible to confirm they have remained under regular treatment for HIV to week 48 - Frequency of combination antiretroviral therapies given to participants on the data cohort Exploratory endpoints - Viral reservoir (total HIV DNA) during study - Viral load measured by single copy assays with sensitivity for 1-20 copies/ml at week 24 and week 48 - Occurrence of viral resistance identified through ultrasensitive viral resistance testing - Investigation of T-cell activation during study - Metabolomics: Investigation of the metabolic changes associated with study treatments. - Investigation of effect of study treatments upon platelet and | — |
Countries
United Kingdom
Contacts
Public ContactResearch and Development Office
Chelsea and Westminster Hospital NHS Foundation Trust
Outcome results
None listed