Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV

Inclusion Criteria

• •PWH aged ≥18 to ≤64 years old at screening
• •* Able to give informed written consent including consent to long-term follow-up
• •* Willing and able to comply with visit schedule and provide blood sampling
• •* Willing to consent to their HIV care team being informed of their participation and sharing relevant clinical information
• •* Stable on oral ART with suppressed undetectable HIV pVL 'target not detected' (TND) using local assays for ≥ 1 years (a single viral load measurement \>50 but \<500 copies/ml during this time period is allowable)
• •* No evidence of viral insensitivity to GS-2872 based on proviral sequencing
• •* No significant co-morbidities according to the investigator's opinion
• •* Nadir CD4 \>200 cells/µl unless treatment commenced during documented acute seroconversion
• •* Current CD4 count \>500 cells/µl or CD4:CD8 ratio \>1.0
• •* On integrase inhibitor (INSTI) or boosted protease inhibitor (bPI) based regimen at time of randomisation. If previously on non-nucleoside reverse transcriptase inhibitor (NNRTI) must have switched at least 4 weeks prior to randomisation
• •* Adequate haemoglobin (Hb ≥12 g/dL for males, ≥11 g/dL for females)
• •* Weight ≥ 50kg
• •* Has received at least 3 doses of vaccination against coronavirus (COVID-19), at least 4 weeks prior to randomisation
• •* Has received current seasonal vaccination against Influenza\*
• •* People of childbearing potential\*\* must agree to use hormonal contraception, intrauterine device, intrauterine hormone-releasing system, or otherwise practice complete abstinence\*\*\* from at least two weeks before the first Investigational Medicinal Product (IMP) administration, for at least 20 months after the last IMP administration, and until undetectable viral load on ART
• •* All participants must agree to take precautions to prevent onward transmission of HIV (such as condoms or PrEP) whilst they are off ART and/or have a detectable viral load \* Applicable during Influenza season (September-April inclusive). \*\*Individuals capable of becoming pregnant are defined as those who are fertile, with childbearing reproductive organs, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Permanent sterilisation of the participant's sole partner (e.g. vasectomy) is also accepted.
• •A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in those not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
• •\*\*\*Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the participant. Barrier contraception, periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods), withdrawal and progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action are not acceptable methods of contraception.