A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)
DescriptionThe purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
PhasePhase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- Men and non-pregnant women with chronic HIV-1 infection
- Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
- Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)
- Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
- Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
- Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort
- Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
- HIV-2 infection
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN
- Alkaline Phosphatase > 5 x ULN
- Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.