Active not recruitingPHASE3INTERVENTIONAL

Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

This research study is testing a new medication called BMS-663068, which is a type of 'attachment inhibitor.' It's designed for people living with HIV-1 who have already received many treatments and whose virus has become resistant to several existing drugs. This means their current HIV medicines are not keeping the virus under control. The study aims to find out if this new drug is effective in helping these individuals. Participants will either receive the new drug or a placebo (a dummy drug) in addition to other HIV medicines that still work for them. The goal is to discover if BMS-663068 can offer a new treatment option for those with complex, multi-drug resistant HIV.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ViiV Healthcare

Enrolment target

371

Start

23 Feb 2015

Estimated completion

30 Sep 2026

HIV Infections

What is this study about?

This study is about finding new ways to help people living with HIV, specifically those who have already tried many different HIV medications. Sometimes, the HIV virus can change and become resistant to the medicines that used to work. This means the treatments are no longer effective at keeping the virus under control. When this happens, it can be really challenging to find new treatment options that work well.

Researchers are looking at a new drug, which they just call BMS-663068 for now. This drug is a type of 'attachment inhibitor.' This means it works by stopping the HIV virus from attaching itself to healthy cells in the body, which is how the virus usually spreads. By blocking this attachment, the drug aims to stop the virus from multiplying, even if it has become resistant to other types of drugs.

The main goal of this study is to see if BMS-663068 can effectively lower the amount of HIV in the blood (known as viral load) for people who have already used many treatments and have drug-resistant HIV. Finding new and effective treatments is very important for these individuals, as it could offer them a better quality of life and improved health outcomes.

Key takeaways

Tests a new HIV drug for people with drug-resistant HIV.
Aims to help those whose current treatments aren't working.
Compares the new drug to a placebo in some participants.
Focuses on a specific group: adults with long-term, complex HIV.
Could offer a new treatment option if successful.

Who may be eligible?

To join this study, you need to be an adult (18 or older) who has HIV-1. You must have already tried many different HIV medications, and your doctors will have a record showing that your HIV has become resistant to some of these drugs, or that you couldn't tolerate them. Your current HIV treatment also needs to not be working well, meaning the amount of HIV in your blood is still high.

Another important point is that you should still have at least one or two other HIV medicines that are known to work well for you. These will be given alongside the new study drug. If you don't have any other fully effective drugs left, you might still be able to join a different part of the study.

However, there are some reasons why you wouldn't be able to join. For example, if you have an untreated Hepatitis B infection, or if you have HIV-2 (a different type of HIV). Also, if your blood tests show very high levels that suggest severe liver problems, you wouldn't be able to take part. Women who are pregnant also cannot join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or over?
Do you have HIV-1 and have you tried many treatments before?
Is your current HIV medication not fully controlling your virus?
Do you have at least one or two other HIV medicines that your doctor says still work for you?
Do you *not* have untreated Hepatitis B or HIV-2?
Are your liver blood tests within certain limits?

Answer every question to see your result.

What does participation involve?

The detailed plan for what taking part involves isn't fully described here, but generally in studies like this, you would have regular visits to the clinic for check-ups and blood tests. You would receive either the new drug (BMS-663068) or a placebo (a dummy pill, which looks like the real drug but has no active ingredients) in addition to other HIV medications that your doctor and the study team decide are right for you. Your health would be carefully monitored throughout the study. The total duration of participation isn't specified, but clinical trials usually involve a period of taking the study medication, followed by regular follow-up appointments.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, potentially effective treatment (BMS-663068) before it's widely available, especially if you have limited options due to drug resistance. However, like all medications, the new drug could have side effects, and some participants will receive a placebo instead of the active drug. The specific risks and side effects of BMS-663068 are not detailed here. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (139)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Palm Springs, United States
GSK Investigational Site
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San Francisco, United States
GSK Investigational Site
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Denver, United States
GSK Investigational Site
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New Haven, United States
GSK Investigational Site
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Washington D.C., United States
GSK Investigational Site
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Washington D.C., United States
GSK Investigational Site
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Ft. Pierce, United States
GSK Investigational Site
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Orlando, United States

Common questions

What is an 'attachment inhibitor'?

It's a type of drug that stops the HIV virus from attaching to your healthy cells, which helps prevent the virus from spreading.

What does 'heavily treatment experienced' mean?

It means you have already tried many different HIV treatments over time, and some of them may no longer be working well or you couldn't tolerate them.

What is multi-drug resistance?

This is when the HIV virus in your body has changed and become resistant to several different types of HIV medications, meaning they are no longer effective.

Will I definitely get the new drug?

In some parts of the study, participants are randomly assigned to receive either the new drug or a placebo (a dummy drug). In another part, only the new drug is given.

What if I have Hepatitis B?

If your Hepatitis B is being treated, you might still be able to join. But if it's untreated, you would not be eligible.