Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

This research study is looking into new treatments for children and teenagers (from 4 weeks old up to their 18th birthday) who have HIV. The main goal is to understand if certain medications, called cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted Darunavir (DRV/co), and Emtricitabine/Tenofovir Alafenamide (F/TAF), are safe and effective for this age group. By carefully studying how these drugs work and what their best doses are, doctors hope to find better and safer ways to manage HIV in younger patients. This is very important as children living with HIV need medicines that are suitable for their growing bodies and help them live healthy lives.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Gilead Sciences

Enrolment target

133

Start

16 Jan 2014

Estimated completion

01 Mar 2027

Acquired Immune Deficiency Syndrome (AIDS)HIV Infections

What is this study about?

This research study is focused on children and teenagers who are living with HIV. The main purpose of this study is to find out more about some specific medications used to treat HIV. These medicines are called cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted Darunavir (DRV/co), and Emtricitabine/Tenofovir Alafenamide (F/TAF). Doctors want to learn if these drugs are safe for young people and what the correct doses should be.

Finding the right treatment for children with HIV is very important. Their bodies process medicines differently than adults, so it's essential to ensure treatments are both effective and safe for growing children. This study will help doctors understand how these particular medicines work in children and if they can be used as good options to help manage HIV.

The information gathered from this study will help healthcare professionals make better decisions about treating HIV in children and teenagers in the future. It's all about improving the health and well-being of young people living with HIV.

Key takeaways

This study is for children and teenagers (4 weeks to under 18) with HIV.
It's testing the safety and dosage of new HIV medications (ATV/co, DRV/co, F/TAF).
The goal is better HIV treatment options for young people.
Participants must have stable HIV control before joining.
You can withdraw your child from the study at any time.

Who may be eligible?

To join this study, children and teenagers must have HIV. They need to be between 4 weeks old and just under 18 years old. Also, their current HIV treatment needs to have been working well and stable for at least 3 months before starting the study.

The child's weight is also important. Depending on their weight, they might be placed into different groups within the study. This helps researchers ensure the correct dose is given for their size. Most children will already be on HIV medication and will switch to the study drugs. Some may be new to treatment.

Even if a child's doctor has recently made small changes to their HIV treatment because they've grown or needed a different formulation of their medication, they can still be considered for the study. The important thing is that their HIV has been well-controlled.

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.

Is your child between 4 weeks and just under 18 years old?
Does your child have HIV?
Has your child's HIV treatment been stable and working well for at least 3 months?
Is your child within certain weight ranges for their age (these will be discussed by the doctor)?
Is your child currently on HIV medication or starting treatment soon?

Answer every question to see your result.

What does participation involve?

Information about participation is not fully detailed in the provided text. Typically, taking part in a clinical trial involves regular visits to the clinic for health checks, blood tests, and to receive the study medication. These visits usually happen over several months or even longer. You would be given the new study drugs, and doctors would monitor your child's health closely to see how they are responding and if there are any side effects. The total duration of participation can vary, but generally involves an initial set of tests, receiving the new medicines, and then follow-up appointments.

Potential risks and benefits

Potential benefits of joining the study could include access to new, potentially effective HIV treatments before they are widely available. Your child would also receive close medical attention and monitoring. However, like all medications, the study drugs may have side effects, and some may not yet be fully known. There is also no guarantee that the new treatment will be more effective than your child's current medication. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (23)

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

Pediatric Infectious Disease Associates
Verified postcode
Long Beach, United States
Peter Morton Medical Building
Verified postcode
Los Angeles, United States
University of Colorado Denver
Verified postcode
Aurora, United States
The George Washington University
Verified postcode
Washington D.C., United States
University of South Florida
Verified postcode
Tampa, United States
St. Jude Children's Research Hospital
Verified postcode
Memphis, United States
University of Texas Health Science Center of Houston
Verified postcode
Houston, United States
Hospital General de Agudos Cosme Argerich
Verified postcode
Buenos Aires, Argentina
Helios Salud
Verified postcode
Buenos Aires, Argentina
University of the Free State
Verified postcode
Bloemfontein, South Africa
University of Stellenbosch
Verified postcode
Cape Town, South Africa
King Edward VIII Hospital
Verified postcode
Durban, South Africa

Common questions

What is HIV?

HIV stands for Human Immunodeficiency Virus. It's a virus that attacks the body's immune system, which is what helps fight off infections.

Are the study drugs new?

Some of the drugs being studied are new combinations or formulations, or they are being tested in children for the first time in this way. They aim to find better ways to treat HIV in younger people.

What is 'cobicistat-boosted' mean?

Cobicistat is a substance that helps other HIV medicines stay in the body for longer, making them more effective. So, 'cobicistat-boosted' means the medicine is combined with cobicistat.

Will my child stop their current HIV medication?

For most participants, if eligible, your child would switch from their current HIV medication regimen to the new study drugs after being carefully assessed by the study doctors.

What if my child feels unwell during the study?

If your child feels unwell or has any concerns during the study, you should always tell the study team immediately. They will monitor your child closely and provide care as needed.