Evidence map›Paper›PMID 37837376›Full record

ArticleHIV research & clinical practice2023

Participant experiences in HIV cure-directed trial with an extended analytical treatment interruption in Philadelphia, United States.

Andrea Bilger, Eion Plenn, Frances K Barg, Katharine A Rendle, William B Carter, Andrea Lamour-Harrington, Nora Jones, Beth Peterson, John A Sauceda, Pablo Tebas and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in HIV research & clinical practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03588715 (Pilot Study on Innate Activation and Viral Control in HIV-Infected Adults Undergoing an Analytical Treatment Interruption After Administration of Pegylated Interferon Alpha 2b With Broadly HIV-1 Neutralizing Antibodies), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03588715 phase1unknown statusnot on this map

Pilot Study on Innate Activation and Viral Control in HIV-Infected Adults Undergoing an Analytical Treatment Interruption After Administration of Pegylated Interferon Alpha 2b With Broadly HIV-1 Neutralizing Antibodies (3BNC117, 10-1074)

TypeinterventionalSponsorLuis MontanerRan2020 to 2022Enrolled15ConditionsHIV, HIV/AIDS, HIV-1 InfectionArmsPegylated Interferon alpha 2b (peg-IFN-α2b), 3BNC117 + 10-1074
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Observational
  9. Article
  10. Post-intervention control in HIV immunotherapy trials.Current opinion in HIV and AIDS · 2025
    Review
  11. Article
  12. Article
  13. Article
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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

14 authors.

Andrea BilgerDepartment of Family Medicine and Community Health, University of Pennsylvania, Pennsylvania, PA, USA.
Eion PlennDepartment of Family Medicine and Community Health, University of Pennsylvania, Pennsylvania, PA, USA.
Frances K BargDepartment of Family Medicine and Community Health, University of Pennsylvania, Pennsylvania, PA, USA.
Katharine A RendleDepartment of Family Medicine and Community Health, University of Pennsylvania, Pennsylvania, PA, USA.
William B CarterBEAT-HIV Delaney Collaboratory Community Advisory Board, Philadelphia, PA, USA.
Andrea Lamour-HarringtonBEAT-HIV Delaney Collaboratory Community Advisory Board, Philadelphia, PA, USA.
Nora JonesBEAT-HIV Delaney Collaboratory Community Advisory Board, Philadelphia, PA, USA.
Beth PetersonWistar Institute, Philadelphia, PA, USA.
John A SaucedaDivision of Prevention Sciences, Department of Medicine, Center for AIDS Prevention Studies (CAPS), University of California, San Francisco, CA, USA.
Pablo TebasHospital of the University of Philadelphia, University of Pennsylvania, Pennsylvania, PA, USA.
Karam MounzerPhiladelphia FIGHT Community Health Centers, Philadelphia, PA, USA.
David MetzgerDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Pennsylvania, PA, USA.
Luis J MontanerWistar Institute, Philadelphia, PA, USA.
Karine DubéDivision of Infectious Diseases and Global Public Health, University of California San Diego School of Medicine, La Jolla, CA, USA.ORCID 0000-0003-3458-1539

Funding

BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination ImmunotherapyUM1AI164570 · NIAID · WISTAR INSTITUTE · PI Luis J Montaner, James L. Riley · 2021 to 2026
$34.7M
First-in-human study of two anti-SARS CoV-2 antibodies in health volunteersUM1AI126620 · NIAID · WISTAR INSTITUTE · PI MONTANER, LUIS J, RILEY, JAMES L. · 2016 to 2021
$24.5M
Penn Mental Health AIDS Research CenterP30MH097488 · NIMH · UNIVERSITY OF PENNSYLVANIA · PI Karine Dube, Kelly L Jordan-Sciutto · 2013 to 2026
$23.5M
Training Program for Scientists Conducting Research to Reduce HIV Health DisparitR25MH067127 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Emily A Arnold, Torsten Brian Neilands · 2003 to 2026
$5.4M
Investigating Psychosocial Experiences of HIV Cure Trial Participants Undergoing Extended HIV Treatment Interruptions: Implications for Ethical ConductR01MH126768 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DUBE, KARINE, SAUCEDA, JOHN ANDREW · 2021 to 2025
$3.6M
NIAID NIH HHS UM1 AI126620NIAID NIH HHS UM1 AI164570NIMH NIH HHS P30 MH097488NIMH NIH HHS R01 MH126768NIMH NIH HHS R25 MH067127
6 · The paper itself

Abstract

backgroundA feature of HIV cure trials is the need to interrupt treatment to test the efficacy of experimental interventions-a process known as analytical treatment interruptions (ATIs).

objectivesWe report the experiences of participants after they completed an extended ATI.

methodsFrom April to November 2022, we conducted post-ATI in-depth interviews with BEAT2 clinical trial (NCT03588715) participants who stopped ART while receiving an immunotherapy regimen. We used conventional content analysis to code the data.

resultsWe conducted interviews with 11 Black/African American and three White/Caucasian participants (11 males, two females, and one transgender woman). The mean ATI was 38 weeks. Participants noted several significant experiences surrounding the interventions' side effects, ATI, and returning to medication. Some participants had positive experiences with their ATI. Other participants were nervous during the ATI. Rising viral loads led some to feel a sense of failure. Although trial experiences were heterogeneous, participants unanimously had positive interactions with the clinical trial staff which facilitated their retention in the trial. Participants shared their experiences with the trial, including changes in expectations, experiences with experimental interventions and procedures, compensation as a measure of respect, effort, transportation, and effects of COVID-19 during the trial. Based on these results, we provide considerations for the conduct of future HIV cure-directed clinical trials involving ATIs.

conclusionsManaging expectations, focusing on participants' contributions, and providing support to reduce feelings of having failed the research team and/or the HIV community following viral rebound should be part of HIV cure trial design. Discussing the mental health impact of rebound during consent, distinct from risk, is needed. Continued efforts to understand how people with HIV experience ATIs will improve future designs of HIV cure clinical trials.

Indexed as

COVID-19HIV InfectionsClinical Trials as TopicFemaleHumansImmunotherapyMalePhiladelphiaUnited StatesViral Loadanalytical treatment interruptionsHIV cure researchparticipant experiencespeople with HIVqualitative researchsocio-behavioral research

Identifiers

PMID37837376
PMCPMC10634456

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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.