Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Status: | Active, not recruiting |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/17/2018 |
Start Date: | February 23, 2015 |
End Date: | April 15, 2020 |
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)
The 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.
is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug
resistance.
Inclusion 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
Exclusion Criteria:
- 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)
We found this trial at
36
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials