Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection

Conditions

• HIV-1 Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• Vorinostat — DRUG
  At Step 2 (Enrollment) - subjects receive two paired oral doses of Vorinostat (VOR) 400 mg. Step 5 - Approximately 7- 10 days after the 4th dose of AGS-004 in Step 4 (Visit 11), ten (10) doses of VOR 400 mg will be administered at 72 hour intervals. Steps 6 - 7 \& EOS visit - Repeat cycles of AGS-004 and VOR. Participants will undergo a second series of 4 AGS-004 vaccinations (Step 6) followed by 10 doses of VOR 400 mg PO (Step 7).
• AGS-004 — BIOLOGICAL
  Step 4 - AGS-004 vaccination. AGS-004 product will be delivered in three intradermal injections of 0.2 mL (0.6 mL total volume) for a total of 1.2 x 10-7 viable cells. AGS-004 will be administered every 3 weeks for 4 doses. Steps 6 - 7 \& EOS visit - Repeat cycles of AGS-004 and VOR. Participants will undergo a second series of 4 AGS-004 vaccinations (Step 6) followed by 10 doses of VOR 400 mg PO (Step 7).

Study Details

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.

Key Dates

Start date

Mar 31, 2016

Status verified

Jul 2019

Primary completion

Jul 11, 2018

Completion

Jul 11, 2018

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Vorinostat + AGS-004
  Vorinostat (VOR) 400 mg PO - two paired doses at Step 2 (Enrollment) - Only participants demonstrating an in vivo response to the 2nd of the paired VOR doses will proceed to the AGS-004 manufacturing and treatment in Steps 3 through 7. Step 4 - AGS-004 vaccination. AGS-004 product will be delivered in three intradermal (ID) injections of 0.2 mL (0.6 mL total volume) for a total of 1.2 x 10-7 viable cells. AGS-004 will be administered every 3 weeks for 4 doses.

Primary Outcome Measure

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 ]

Locations (1)

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