NCT02707900: VORVAX

IGHID 11424 - A Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection (The VOR VAX Study)

Terminated Phase 1 Last updated 2 October 2019

What this trial tests

Phase 1 trial testing Vorinostat in HIV-1 Infection in 6 participants. Terminated before completion.

Timeline

1 March 2016

Primary endpoint
11 July 2018

11 July 2018

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	1 March 2016
Primary completion	11 July 2018
Estimated completion	11 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Vorinostat (VORINOSTAT) — full drug profile →
• AGS-004 — full drug profile →

Conditions studied

• HIV-1 Infection — all drugs for HIV-1 Infection →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 64, any sex, with HIV-1 Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in the frequency of HIV infection per million resting CD4+T cells (RCI) from baseline to post-VOR/AGS.
  Time frame: First day of study treatment to between approximately week 43 and week 72 on study
  Change in the frequency of HIV infection per million resting CD4+T cells (RCI) from baseline to post-VOR/AGS.
• Occurrence of at least one ≥ Grade 3 adverse event including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to VOR or AGS-004 any time from the first day of study treatment through the end of study.
  Time frame: First day of study treatment to between approximately week 73 and week 96 on study
  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.

Sponsor's own description

The purpose of this research study is to 1) evaluate the safety of a series of injections with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the immune system can be made stronger to eliminate the activated HIV virus.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in the delivery of RNA therapeutics: from concept to clinical reality.
   Kaczmarek JC, Kowalski PS, Anderson DG. · · 2017 · cited 467× · PMID 28655327 · DOI 10.1186/s13073-017-0450-0
2. Advances in COVID-19 mRNA vaccine development.
   Fang E, Liu X, Li M, Zhang Z, et al · · 2022 · cited 368× · PMID 35322018 · DOI 10.1038/s41392-022-00950-y
3. The timeline of epigenetic drug discovery: from reality to dreams.
   Ganesan A, Arimondo PB, Rots MG, Jeronimo C, et al · · 2019 · cited 234× · PMID 31791394 · DOI 10.1186/s13148-019-0776-0
4. Curing HIV: Seeking to Target and Clear Persistent Infection.
   Margolis DM, Archin NM, Cohen MS, Eron JJ, et al · · 2020 · cited 144× · PMID 32220311 · DOI 10.1016/j.cell.2020.03.005
5. Novel Latency Reversal Agents for HIV-1 Cure.
   Spivak AM, Planelles V. · · 2018 · cited 140× · PMID 29099677 · DOI 10.1146/annurev-med-052716-031710
6. Recent Developments in mRNA-Based Protein Supplementation Therapy to Target Lung Diseases.
   Sahu I, Haque AKMA, Weidensee B, Weinmann P, et al · · 2019 · cited 83× · PMID 30905577 · DOI 10.1016/j.ymthe.2019.02.019
7. Control of viral infections by epigenetic-targeted therapy.
   Nehme Z, Pasquereau S, Herbein G. · · 2019 · cited 73× · PMID 30917875 · DOI 10.1186/s13148-019-0654-9
8. Advances toward Curing HIV-1 Infection in Tissue Reservoirs.
   Henderson LJ, Reoma LB, Kovacs JA, Nath A. · · 2020 · cited 52× · PMID 31694954 · DOI 10.1128/jvi.00375-19