Trial reportThe Journal of infectious diseases2022
Characterization of Human Immunodeficiency Virus (HIV) Infections in Women Who Received Injectable Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention: HPTN 084.
Trial report 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 45 papers, 2 of them syntheses that pooled it.
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
45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.
- Rapid diagnostic tests, laboratory-based immunoassay and nucleic acid testing strategies for long-acting injectable pre-exposure prophylaxis: A systematic review and meta-analysis.PLoS medicine · 2026Pooled it
- 2025 US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Post-exposure Prophylaxis in Healthcare Settings.Infection control and hospital epidemiology · 2025Guideline
- Influence of the broadly neutralizing antibody VRC01 on HIV breakthrough virus populations in antibody-mediated prevention trials.Nature communications · 2026Trial
- Advancing youth HIV prevention and care in Uganda: stakeholder-informed innovations through implementation science, protocol for a randomized controlled trial.BMC health services research · 2026Trial
- Evaluation of pharmacokinetic interactions between long-acting cabotegravir or emtricitabine/tenofovir disoproxil fumarate and hormonal contraceptive agents: a tertiary analysis of South African participants in HPTN 084.Journal of the International AIDS Society · 2025Trial
- Pharmacologic evaluation of delayed long-acting cabotegravir administration among cisgender women in HPTN 084.Antimicrobial agents and chemotherapy · 2024Trial
- Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.Lancet (London, England) · 2022Trial
- Prophylactic treatment with broadly neutralizing antibody VRC01 selects for escape mutants after infection in Antibody-Mediated Prevention trials.Nature microbiology · 2026Article
- Long-Acting Injectable Antiretroviral Therapies for HIV Treatment and Prevention: Clinical Pharmacology, Recent Advances and Future Opportunities.Journal of clinical pharmacology · 2026Review
- The Critical Importance of Clinical Use Case to Inform Point-of-Care Technology Development: A Case Study of HIV Nucleic Acid Assays in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- HIV serologic reactivity varies with time of ART initiation in persons on long-term ART.Journal of clinical microbiology · 2026Article
- Beyond Efficacy: The Access, Delivery Systems, Acceptability, Persistence, and Transition Management "ADAPT" Framework for Long-Acting Injectable PrEP in Sub-Saharan Africa.HIV/AIDS (Auckland, N.Z.) · 2026Article
- A Darwinian model for the evolution of drug resistance to long-acting PrEP during an early HIV infection.PloS one · 2026Article
- Comparison of manual and automated ultrasensitive assays for residual HIV-1 in plasma from individuals on suppressive antiretroviral therapy.Journal of clinical microbiology · 2025Article
- VRC01 Selects Rare HIV Escape Mutations After Acquisition in Antibody-Mediated Prevention Trials.bioRxiv : the preprint server for biology · 2025Article
- Unique molecular signatures in rebound viruses from antiretroviral drug and CRISPR-treated HIV-1-infected humanized mice.Communications biology · 2025Article
- Improved HIV-1 RNA detection using whole blood versus plasma in antiretroviral-treated individuals.Journal of clinical microbiology · 2025Article
- Assessing phenotypic effect of integrase strand-transfer inhibitor (INSTI)-based resistance substitutions associated with failures on cabotegravir.The Journal of antimicrobial chemotherapy · 2025Article
- Long-acting Antiretroviral Agents in the Prevention and Treatment of HIV/AIDS: A Review of Recent Advances in Sub-Saharan Africa.International journal of MCH and AIDS · 2025Article
- HIV DNA Levels in Persons Who Acquired HIV in the Setting of Long-Acting Cabotegravir for HIV Prevention: Analysis of Cases from HPTN 083 and 084.AIDS research and human retroviruses · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
33 authors at 16 institutions in 4 countries.
Funding
Abstract
backgroundHIV Prevention Trials Network 084 demonstrated that long-acting injectable cabotegravir (CAB) was superior to daily oral tenofovir (TFV) disoproxil fumarate (TDF)/emtricitabine (FTC) for preventing human immunodeficiency virus (HIV) infection in sub-Saharan African women. This report describes HIV infections that occurred in the trial before unblinding.
methodsTesting was performed using HIV diagnostic assays, viral load testing, a single-copy RNA assay, and HIV genotyping. Plasma CAB, plasma TFV, and intraerythrocytic TFV-diphosphate concentrations were determined by liquid chromatography-tandem mass spectrometry.
resultsForty HIV infections were identified (CAB arm, 1 baseline infection, 3 incident infections; TDF/FTC arm, 36 incident infections). The incident infections in the CAB arm included 2 with no recent drug exposure and no CAB injections and 1 with delayed injections; in 35 of 36 cases in the TDF/FTC arm, drug concentrations indicated low or no adherence. None of the cases had CAB resistance. Nine women in the TDF/FTC arm had nonnucleoside reverse-transcriptase inhibitor resistance; 1 had the nucleoside reverse-transcriptase inhibitor resistance mutation, M184V.
conclusionsAlmost all incident HIV infections occurred in the setting of unquantifiable or low drug concentrations. CAB resistance was not detected. Transmitted nonnucleoside reverse-transcriptase inhibitor resistance was common; 1 woman may have acquired nucleoside reverse-transcriptase inhibitor resistance from study drug exposure.
Indexed as
Identifiers
What OpenQuestion holds
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.