Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

This study is investigating a new medication, lenacapavir, for individuals living with HIV-1 infection. It's specifically for those whose current HIV treatments are no longer working effectively due to the virus becoming resistant to multiple medicines. The main goal is to find out if adding lenacapavir to their existing treatment for a short period can help lower the amount of HIV in their body. Researchers will also look at how safe the new drug is and how well it works over a longer time when combined with other effective HIV medicines. This is an important step towards finding new options for people with complex HIV-1 infection.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Gilead Sciences

Enrolment target

Start

21 Nov 2019

Estimated completion

01 Jan 2027

HIV-1-infection

Results

Results from this study

Posted October 2021

Results have been published for this study.

Primary outcome

Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period

Full results on the registry

What is this study about?

This study is looking at a new medicine called lenacapavir, designed for people living with HIV-1. HIV, or human immunodeficiency virus, is a condition that affects your immune system. While there are many effective treatments for HIV, some people find that over time, the virus changes and becomes resistant to the medicines they are taking. This means their current treatments might stop working as well as they used to.

The study aims to help people who are in this situation – those whose HIV has become resistant to several different types of medication. The researchers want to see if adding lenacapavir to their current treatment can help reduce the amount of HIV in their body. This process will happen in two main stages: first, they'll check how well lenacapavir works on its own for a short time, and then they'll see how it performs when combined with other effective HIV medicines.

Finding new treatment options is really important for people with multi-drug resistant HIV, as it can be challenging to manage their condition. This study hopes to provide data that could eventually lead to new ways to help people keep their HIV under control and improve their overall health.

Key takeaways

This study is for people with HIV-1 whose current treatments are not fully effective.
It tests a new medicine, lenacapavir, for multi-drug resistant HIV.
Participation involves taking new medicine (pills and injections) and regular doctor visits.
You might receive a placebo initially, but everyone eventually receives the new drug.
The study aims to find new ways to treat complex HIV infections.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old. In some parts of the world, like North America, teenagers aged 12 and above who weigh at least 35 kg might also be able to join. You need to have been on an HIV treatment for more than 8 weeks that isn't currently working well for you, meaning your blood test shows a certain level of HIV in your body.

Additionally, your HIV must show signs of resistance to several different types of existing HIV medications. This means your doctors would confirm that your HIV is difficult to treat with many standard drugs. You should also not have an ongoing Hepatitis C infection at the time of screening.

Your doctor will be able to check all these details to see if you meet the full requirements for taking part in 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 aged 18 or over (or 12-17 and at least 35kg in some regions)?
Is your current HIV medicine not fully controlling your virus?
Has your doctor told you your HIV is resistant to several different treatments?
Do you not have an active Hepatitis C infection?
Are you able and willing to take new medicines as directed?
Could you attend regular hospital visits for check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you might receive either the new medicine, lenacapavir, or a dummy pill (placebo) for a short period, in addition to your current HIV treatment. After this initial stage, all participants will receive lenacapavir along with a new combination of HIV medicines chosen by your doctors that are expected to work well for you. This will involve taking pills by mouth and also receiving some injections under the skin. You'll have regular hospital visits, blood tests, and check-ups to monitor your health, how the medicine is affecting your HIV, and to look for any side effects. The total duration of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer the potential benefit of accessing a new treatment for your HIV-1 infection, especially if your current medications aren't working as well as they used to. This could lead to a reduction in the amount of virus in your body. However, like all medicines, lenacapavir may have side effects, which could range from mild to more serious. You will be closely monitored by the study team for any health changes. Remember, joining any study is completely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (75)

Ruane Clinical Research Group Inc
Verified postcode
Los Angeles, United States
Mills Clinical Research
Verified postcode
Los Angeles, United States
Eisenhower Health Center at Rimrock
Verified postcode
Palm Springs, United States
One Community Health
Verified postcode
Sacramento, United States
Yale University; School of Medicine
Verified postcode
New Haven, United States
Washington Health Institute
Verified postcode
Washington D.C., United States
Midland Florida Clinical Research Center, LLC
Verified postcode
DeLand, United States
Gary J. Richmond, M.D., P.A.
Verified postcode
Fort Lauderdale, United States
Midway Immunology and Research Center
Verified postcode
Ft. Pierce, United States
Floridian Clinical Research
Verified postcode
Hialeah, United States
AIDS Healthcare Foundation - South Beach
Verified postcode
Miami Beach, United States
Orlando Immunology Center
Verified postcode
Orlando, United States

Common questions

What is multidrug resistance (MDR) in HIV?

Multidrug resistance means that the HIV in your body has changed and become resistant to several different types of HIV medicines, making your current treatments less effective.

What is an 'Optimized Background Regimen' (OBR)?

An OBR is a new combination of existing HIV medicines chosen by your doctor that are expected to work well for you, even if your HIV has some resistance.

Will I know if I'm getting the active drug or a placebo?

Initially, it's possible you might get a placebo, and you won't know which one you're receiving. However, after a short period, all participants will receive the active study medicine, lenacapavir.

How is lenacapavir given?

Lenacapavir will be given as a tablet you take by mouth and also as an injection under your skin.

Can I stop taking part in the study at any time?

Yes, your participation is completely voluntary, and you can decide to stop taking part at any time without it affecting your future medical care.