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HIV pill genvoya tested in teens and kids – could simplify treatment

NCT ID NCT01854775

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the HIV medication Genvoya (a single daily pill) in 129 teenagers and children with HIV. The goal was to check how the drug is processed in the body, confirm the right dose, and see if it is safe. Participants included teens new to HIV treatment and children who already had the virus under control. The results help doctors know how to use this medicine in younger patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide)
What this could lead to
If successful, this study helps confirm that Genvoya is safe and works well for treating HIV in teenagers and children, offering a simpler once-daily pill option.
What could go wrong
This is an early-to-mid stage study with a small number of participants (129). It focuses on dosing and short-term safety, not long-term outcomes. Side effects or lack of effectiveness in younger children are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

129 people

The number who actually took part.

Started

May 2013

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Cohort 1 * Age at baseline: 12 years to \< 18 years old * Weight at screening: ≥ 35 kg (77 lbs) * Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0) * Screening genotype report shows sensitivity to EVG, emtricitabine (FTC) and tenofovir (TFV) * No prior use of any approved or experimental anti-HIV-1 drug for any length of time * Cohort 2 * Age at baseline: 6 years to \< 12 years old * Weight at screening: ≥ 25 kg (55 lbs) * Plasma HIV-1 RNA of \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR. * Cohort 3 * Age at baseline: ≥ 2 years old * Weight at screening: ≥ 14 kg (31 lbs) to \< 25 kg (55 lbs) * Plasma HIV-1 RNA: \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \> 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR Key Exclusion Criteria: * Hepatitis B or hepatitis C virus infection * Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit. * Individuals experiencing decompensated cirrhosis * Pregnant or lactating females Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

acquired immunodeficiency AIDS HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acquired immune deficiency syndrome (AIDS) HIV infections

Contacts and locations

Locations

  • Be Part Yoluntu Centre

    Cape Town, 7646, South Africa

  • Children's Research Institute

    Washington D.C., District of Columbia, 20010, United States

  • Clinical HIV Research Unit

    Johannesburg, 2041, South Africa

  • Department of Pediatrics, Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002, Thailand

  • Desmond Tutu HIV Foundation

    Cape Town, 7705, South Africa

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Empilweni Services and Research Unit (ESRU)

    Johannesburg, 2092, South Africa

  • Joint Clinical Research Centre

    Kampala, PO Box 10005, Uganda

  • KIDCRU Ward J8

    Cape Town, 7505, South Africa

  • Miller's Children Hospital

    Long Beach, California, 90806, United States

  • Perinatal HIV Research Unit Baragwanath Hospital

    Johannesburg, 1862, South Africa

  • Queen Savang Vadhana Memorial Hospital

    Chon Buri, 20110, Thailand

  • Seattle Children's Hospital

    Seattle, Washington, 98105-0371, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

    Bangkok, 10330, Thailand

  • University of Zimbabwe - Clinical Research Centre

    Belgravia, 263, Zimbabwe

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