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New HIV drug combo studied in kids for better virus control

NCT ID NCT02016924

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how safe and effective certain HIV medicines are for children and teens (ages 4 weeks to under 18 years) who already have the virus under control. Participants take a combination of drugs (atazanavir or darunavir boosted with cobicistat, plus emtricitabine/tenofovir alafenamide) to keep the virus suppressed. The goal is to find the right doses and confirm the drugs work well in younger patients.

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

133 people

The number who actually took part.

Started

Jan 2014

Expected to finish

Mar 2027

An estimate. End dates often move.

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

4 weeks 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: * HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to \< 18 years (according to requirements of enrolling Cohort). * Body weight at screening ≥ 25 to \< 40 kg (Cohort 2); ≥ 14 to \< 25 kg (Cohort 3); ≥ 3 to \< 25 kg (Cohort 4); ≥ 3 to \< 14 kg (Cohort 5). * Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit. * Participants enrolled prior to implementation of Amendment 7: 2 nucleoside reverse transcriptase inhibitors (NRTIs) and ritonavir-boosted atazanavir (ATV/r) once daily or ritonavir-boosted darunavir (DRV/r) once daily or twice daily. * Participants enrolled after the implementation of Amendment 9: * Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local prescribing guidelines. Participants will switch from their current third agent to ATV or darunavir (DRV) at Day 1. Participants taking DRV must be on once-daily dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group 1), participants may also switch their current third agent to lopinavir boosted with ritonavir (LPV/r) at Day 1. Participants will switch their NRTI backbone to emtricitabine/tenofovir alafenamide (coformulated; Descovy®) (F/TAF). * Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): 2 NRTIs plus a third agent per local prescribing guidelines or treatment naive. Participants on treatment will switch from their current third agent to ATV or LPV/r (Cohort 4 (Groups 2 to 4)), or to a third unboosted agent (Cohort 5 (Groups 1 to 3)). Participants will switch their NRTI backbone to F/TAF. * Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen. * Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) for ≥ 3 months preceding the screening visit: * Participants enrolled after the implementation of Amendment 9: * For Cohorts 2, 3, and 4 (Group 1), virologically suppressed ≥ 3 months preceding the screening visit: HIV-1 RNA \< 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). * For Cohorts 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3), on an ARV regimen irrespective of plasma HIV-1 RNA copies or treatment naive; a participant is considered treatment naive, if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment. * For virologically suppressed participants, unconfirmed virologic elevations of HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL (eg, \< 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive HIV-1 RNA tests. * Adequate renal function: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73m2 using the Schwartz formula. If ≥ 1 year old, eGFR greater than or equal to the minimum normal value for age using the Schwartz formula. If \< 1 year old as follows: * Age minimum value for eGFR (mL/min/1.73 m2) \> 28 days to ≤ 95 days is 30, ≥ 96 days to ≤ 6 months is 39, \> 6 to \< 12 months is 49. * Participants must not have documented or suspected resistance to applicable study drugs including emtricitabine (Emtriva®) (FTC), TFV, ATV, DRV, or LPV. Participants \< 14 kg (Cohorts 4 (Groups 2 to 4) and 5 (Groups 1 to 3)) with M184V/I AND HIV-1 RNA \< 50 copies/mL will be allowed. * Positive confirmatory HIV test (confirmatory nucleic acid-based testing if \< 18 months of age). * Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): Last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment. Note: Other protocol defined Inclusion/Exclusion criteria do 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

  • AMBSO Masaka Clinical Research Site

    Masaka, Uganda

  • HIV-NAT

    Bangkok, 10330, Thailand

  • Helios Salud

    Buenos Aires, C1141 ACG, Argentina

  • Hospital General de Agudos Cosme Argerich

    Buenos Aires, 1151, Argentina

  • Imperial College Healthcare NHS Trust

    London, W2 1NY, United Kingdom

  • King Edward VIII Hospital

    Durban, 3629, South Africa

  • MU-JHU Research Collaboration/MU-JHU Care Ltd

    Kampala, 256, Uganda

  • Pediatric Infectious Disease Associates

    Long Beach, California, 90806, United States

  • Perinatal HIV Research Unit

    Soweto, 2013, South Africa

  • Peter Morton Medical Building

    Los Angeles, California, 90095, United States

  • Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd

    Johannesburg, 2093, South Africa

  • SICRA-TASO Mulago National Referral Hospital

    Kampala, Uganda

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • The Aurum Institute: Pretoria Clinical Research Centre

    Pretoria, 87, South Africa

  • The George Washington University

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

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Stellenbosch

    Cape Town, 7505, South Africa

  • University of Texas Health Science Center of Houston

    Houston, Texas, 77030, United States

  • University of Zimbabwe Clinical Research Centre

    Harare, Zimbabwe

  • University of the Free State

    Bloemfontein, 9300, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.