{"doi":"10.1093/infdis/jiaa777","title":"A Phase 1/2 Randomized, Placebo-Controlled Trial of Romidespin in Persons With HIV-1 on Suppressive Antiretroviral Therapy","abstract":"BACKGROUND: Romidepsin (RMD) is a histone deacetylase inhibitor reported to reverse HIV-1 latency. We sought to identify doses of RMD that were safe and induced HIV-1 expression. METHODS: Enrollees had HIV-1 RNA <40 copies/mL on antiretroviral therapy. Measurements included RMD levels, plasma viremia by single-copy HIV-1 RNA assay, HIV-1 DNA, cell-associated unspliced HIV-1 RNA (CA-RNA), acetylation of histone H3-lysine-9 (H3K9ac+), and phosphorylation of transcription factor P-TEFb. Wilcoxon tests were used for comparison. RESULTS: In the single-dose cohorts 1-3, 43 participants enrolled (36 participants 0.5, 2, 5 mg/m 2 RMD; 7 placebo) and 16 enrolled in the multidose cohort 4 (13 participants 5 mg/m 2 RMD; 3 placebo). One grade 3 event (neutropenia) was possibly treatment related. No significant changes in viremia were observed in cohorts 1-4 compared to placebo. In cohort 4, pharmacodynamic effects of RMD were reduced proportions of CD4+ T cells 24 hours after infusions 2-4 (median, -3.5% to -4.5%) vs placebo (median, 0.5% to 1%; P ≤ .022), and increased H3K9ac+ and phosphorylated P-TEFb in CD4 + T cells vs placebo (P ≤ .02). CONCLUSIONS: RMD infusions were safe but did not increase plasma viremia or unspliced CA-RNA despite pharmacodynamic effects on CD4 + T cells. CLINICAL TRIALS REGISTRATION: NCT01933594.","journal":"The Journal of Infectious Diseases","year":2020,"id":90987,"datarank":1.4692253513740303,"base_score":3.8918202981106265,"endowment":3.8918202981106265,"self_citation_contribution":0.5837730447165941,"citation_network_contribution":0.8854523066574362,"self_endowment_contribution":0.5837730447165941,"citer_contribution":0.8854523066574362,"corpus_percentile":null,"corpus_rank":null,"citation_count":48,"citer_count":41,"citers_with_citation_signal":36,"citers_with_endowment":36,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9547,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT01933594"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":456185,"name":"Lu Zheng","orcid":"0000-0002-8248-3426","position":1,"is_corresponding":false},{"id":258961,"name":"Joshua C. Cyktor","orcid":"0000-0003-3601-4837","position":2,"is_corresponding":false},{"id":457750,"name":"Evgenia Aga","orcid":null,"position":3,"is_corresponding":false},{"id":259559,"name":"Bernard Macatangay","orcid":"0000-0002-0405-0991","position":4,"is_corresponding":false},{"id":247283,"name":"Catherine Godfrey","orcid":"0000-0002-5797-7950","position":5,"is_corresponding":false},{"id":457751,"name":"Michael F. Para","orcid":null,"position":6,"is_corresponding":false},{"id":258328,"name":"Ronald T. Mitsuyasu","orcid":"0000-0002-2627-6246","position":7,"is_corresponding":false},{"id":384296,"name":"Joseph Hesselgesser","orcid":null,"position":8,"is_corresponding":false},{"id":261330,"name":"Joan Dragavon","orcid":null,"position":9,"is_corresponding":false},{"id":456186,"name":"Curtis Dobrowolski","orcid":"0000-0001-6576-8318","position":10,"is_corresponding":false},{"id":456187,"name":"Jonathan Karn","orcid":"0000-0002-2900-094X","position":11,"is_corresponding":false},{"id":296851,"name":"Edward P. Acosta","orcid":null,"position":12,"is_corresponding":false},{"id":88092,"name":"Rajesh T. Gandhi","orcid":"0000-0002-9701-6062","position":13,"is_corresponding":false},{"id":258969,"name":"John W. Mellors","orcid":"0000-0002-3737-9742","position":14,"is_corresponding":false},{"id":259561,"name":"Deborah K. McMahon","orcid":"0000-0002-4374-3539","position":0,"is_corresponding":true}],"reference_count":18,"raw_metadata":null,"created_at":"2026-07-18T22:28:45.409789Z","pmid":"34398236","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}