Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
United States, Argentina, Australia371 participantsStarted 2015-02-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for 'heavily treatment experienced' patients with HIV — does my treatment history actually fit that description, and is it worth discussing whether I might qualify to learn more about this study?
2Since this is a Phase 3 trial testing an attachment inhibitor, what does that class of drug do differently from the antiretrovirals I've already tried, and could targeting a different step in how HIV enters cells matter for someone in my situation?
3The trial is measuring how much the virus drops in the blood after just 8 days — what does that short-term viral load change tell us (and not tell us) about whether a drug like this might work long-term for me?
4The trial is listed as 'active not recruiting,' which means they're no longer enrolling new participants — are there other attachment inhibitor studies or similar approaches I should be looking into instead, or is this class of drug available through any other pathway?
5Given that I've already been through multiple HIV treatments, what are the realistic risks of trying an experimental attachment inhibitor at this stage, compared to continuing or adjusting my current regimen?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort