Evidence map›Paper›PMID 38538161›Full record

Trial reportThe lancet. HIV2024

Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study.

Elizabeth D Lowenthal, Jennifer Chapman, Rachel Ohrenschall, Katherine Calabrese, Kristin Baltrusaitis, Barbara Heckman, Dwight E Yin, Allison L Agwu, Conn Harrington, Rodica M Van Solingen-Ristea and 17 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in The lancet. HIV, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03497676 (Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03497676 phase1 / phase2completednot on this map

Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2019 to 2025Enrolled168ConditionsHIV InfectionsArmsOral Cabotegravir (CAB), Oral Rilpivirine (RPV), Long-Acting Injectable Cabotegravir (CAB LA), Long-Acting Injectable Rilpivirine (RPV LA), Combination Antiretroviral Therapy (cART)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
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  10. Acceptability, Facilitators, and Barriers of Long-Acting Injectable Cabotegravir/Rilpivirine Among Youth With HIV in the United States.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 17 institutions in 4 countries.

Elizabeth D LowenthalThe Children's Hospital of Philadelphia, Division of General Pediatrics and Global Health Center, Philadelphia, PA, USA; University of Pennsylvania Perelman School of Medicine, Departments of Pediatrics and Biostatistics, Epidemiology and Informatics, Philadelphia, PA, USA. Electronic address: lowenthale@chop.edu.
Jennifer ChapmanThe Children's Hospital of Philadelphia, Division of General Pediatrics and Global Health Center, Philadelphia, PA, USA.
Rachel OhrenschallUniversity of Pennsylvania School of Nursing, Philadelphia, PA, USA.
Katherine CalabreseFHI 360 IMPAACT Operations Center, Durham, NC, USA.
Kristin BaltrusaitisCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Barbara HeckmanFrontier Science Foundation, Amherst, NY, USA.
Dwight E YinNational Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS, National Institutes of Health (NIH), Rockville, MD, USA.
Allison L AgwuJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Conn HarringtonViiV Healthcare, Research Triangle Park, NC, USA.
Rodica M Van Solingen-RisteaJanssen Research and Development, Beerse, Belgium.
Cynthia C McCoigViiV Healthcare, Madrid, Spain.
Adeola AdeyeyeNational Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS, National Institutes of Health (NIH), Rockville, MD, USA.
Jared KneeboneFrontier Science Foundation, Amherst, NY, USA.
Vasiliki ChountaViiV Healthcare, Research Triangle Park, NC, USA.
Christiana Smith-AndersonUniversity of Colorado School of Medicine, Aurora, CO, USA.
Andres Camacho-GonzalezEmory University School of Medicine, Atlanta, GA, USA.
Jessica D'AngeloNorthwestern University and Lurie Children's Hospital of Chicago, Chicago, IL, USA.
Allison BeardenKeck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
Herta CrauwelsJanssen Research and Development, Beerse, Belgium.
Jenny HuangViiV Healthcare, Research Triangle Park, NC, USA.
Sarah BuissonFHI 360 IMPAACT Operations Center, Durham, NC, USA.
Ryan MilliganFrontier Science Foundation, Amherst, NY, USA.
Shawn WardFrontier Science Foundation, Amherst, NY, USA.
Carolyn Bolton-MooreCentre for Infectious Disease Research in Zambia/University of Alabama Birmingham, Lusaka, Zambia.
Aditya H GaurSt Jude Children's Research Hospital, Memphis, TN, USA.
IMPAACT 2017 Collaborators
IMPAACT 2017 Team
Frontier Science & Technology Research Foundation · USFamily Health International 360 · USTriangle · USChildren's Hospital of Philadelphia · USJanssen (Belgium) · BECancer Research And Biostatistics · USCentre for Infectious Disease Research in Zambia · ZMEmory University · USJohns Hopkins Medicine · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USNorthwestern University · USSt. Jude Children's Research Hospital · USUniversity of Colorado Denver · USUniversity of Pennsylvania · USUniversity of Southern California · USViiV Healthcare (Spain) · ES

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU)UM1AI069399 · NIAID · CHIANG MAI UNIVERSITY · PI Kiat Ruxrungtham, Khuanchai Supparatpinyo · 2012 to 2026
$25.0M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
NIAID NIH HHS U01 AI068632NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069399NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001I
6 · The paper itself

Abstract

backgroundLong-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12-17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study.

methodsIn this a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study, with continuation of pre-study oral combination antiretroviral treatment (ART), 55 adolescents living with HIV-1 were enrolled to receive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two injections. Participants had a body weight greater than 35 kg and BMI less than 31·5 kg/m

findingsBetween March 19, 2019, and Nov 25, 2021, 55 participants were enrolled into cohort 1. Using the six-point face scale, 43 (83%) of participants at week 4 and 38 (73%) at week 8 reported that the injection caused "no hurt" or "hurts little bit", while only a single (2%) participant for each week rated the pain as one of the two highest pain levels. Quality of life was not diminished by the addition of one injectable antiretroviral. In-depth interviews revealed that parents and caregivers in the USA frequently had more hesitancy than adolescents about use of long-acting formulations, but parental acceptance was higher after their children received injections.

interpretationHigh acceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that these are likely to be favoured treatment options for some adolescents living with HIV.

fundingNational Institutes of Health and ViiV Healthcare.

Indexed as

Anti-HIV AgentsDiketopiperazinesHIV-1HIV InfectionsHIV SeropositivityPyridonesAdolescentAdultAnti-Retroviral AgentsChildHumansPainQuality of LifeRilpivirineAnti-HIV AgentsAnti-Retroviral AgentscabotegravirDiketopiperazinesPyridonesRilpivirine

Identifiers

PMID38538161
PMCPMC11061207
OpenAlexW4393176995

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.