Adults 18 to 64, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants w/ at Least One ≥ Grade 3 Adverse Event That is Possibly or Definitely Related to Vorinostat (VOR) or HIV-specific T Cell (HXTC)Primary· Up to end of study (weeks 16 through 45)
Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious adverse events. Safety data will be routinely collected throughout the duration of the study.
Group
Value
95% CI
VOR + HXTC Arm
0
Number of Participants Demonstrating an HIV-specific Immune Response to the Combination of Vorinostat (VOR) and HIV-specific T Cells (HXTC) Therapy as Well as a Change in the Frequency of Latent HIV InfectionSecondary· Up to end of study (weeks 16 through 45)
The change in ex vivo HIV-specific immune response from baseline was measured by interferon-gamma (IFN-γ) ELISpot throughout the study. Change in the frequency of latent HIV infection from baseline to end of study was measured using a quantitative viral outgrowth assay (QVOA). Participants that exhibited any significant changes in both of these measures were considered to have experienced a positive result.
Group
Value
95% CI
VOR + HXTC Arm
0
Adverse events — posted to ClinicalTrials.gov
Time frame: The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a phase I, single-site, study to evaluate the effects of VOR and HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) on persistent HIV-1 Infection in HIV-infected individuals suppressed on ART. Twelve participants with durable viral suppression will be enrolled and will complete the study. All participants will receive the same treatment and if eligible, will be dosed with HXTC and VOR. Participants will continue their baseline ART regimen throughout the study.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07261241 — NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
· Phase 2
· not yet recruiting
NCT05608369 — Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC
· Phase 2
· withdrawn
NCT04339751 — Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease
· Phase 2
· withdrawn
NCT06145633 — Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
NCT05700630 — Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia
· Phase 1
· withdrawn
Other recruiting trials for HIV-1 Infection
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NCT05705349 — DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
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NCT05631093 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir
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NCT05630755 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir
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Other University of North Carolina, Chapel Hill trials
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 12 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03212989.