ArticleThe Journal of infectious diseases2022
Balancing Statistical Power and Risk in HIV Cure Clinical Trial Design.
Article in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 15 citations in OpenAlex.
- 'It is scary to pause treatment': perspectives on HIV cure-related research and analytical treatment interruptions from women diagnosed during acute HIV in Durban, South Africa.HIV research & clinical practice · 2025Article
- Integrating socio-behavioral, ethics, community, and translational science considerations in HIV cure research.Current opinion in HIV and AIDS · 2025Review
- The role of analytical treatment interruptions in shaping HIV-specific immunity and HIV cure.Current opinion in HIV and AIDS · 2025Review
- Applications and limitations of the passenger hypothesis for HIV reservoir persistence and cure.Journal of virology · 2025Review
- Intact HIV DNA decays in children with and without complete viral load suppression.PLoS pathogens · 2025Article
- Early Viral Dynamics Predict Human Immunodeficiency Virus Posttreatment Control After Analytic Treatment Interruption.The Journal of infectious diseases · 2025Article
- Impact of an analytical treatment interruption on partners and family members of trial participants in Durban, South Africa: a qualitative study.Frontiers in public health · 2025Article
- Recall and Appraisal of the Risks, Benefits, and Objectives of Interrupting HIV Treatment in an HIV Cure-Related Study.AIDS and behavior · 2024Article
- Early antiretroviral therapy in SIV-infected rhesus macaques reveals a multiphasic, saturable dynamic accumulation of the rebound competent viral reservoir.PLoS pathogens · 2024Article
- A partner protection package for HIV cure-related trials involving analytical treatment interruptions.The Lancet. Infectious diseases · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnalytical treatment interruptions (ATI) are pauses of antiretroviral therapy (ART) in the context of human immunodeficiency virus (HIV) cure trials. They are the gold standard in determining if interventions being tested can achieve sustained virological control in the absence of ART. However, withholding ART comes with risks and discomforts to trial participant. We used mathematical models to explore how ATI study design can be improved to maximize statistical power, while minimizing risks to participants.
methodsUsing previously observed dynamics of time to viral rebound (TVR) post-ATI, we modelled estimates for optimal sample size, frequency, and ATI duration required to detect a significant difference in the TVR between control and intervention groups. Groups were compared using a log-rank test, and analytical and stochastic techniques.
resultsIn placebo-controlled TVR studies, 120 participants are required in each arm to detect 30% difference in frequency of viral reactivation at 80% power. There was little statistical advantage to measuring viral load more frequently than weekly, or interrupting ART beyond 5 weeks in a TVR study.
conclusionsCurrent TVR HIV cure studies are underpowered to detect statistically significant changes in frequency of viral reactivation. Alternate study designs can improve the statistical power of ATI trials.
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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.