Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to assess the safety and ability of vorinostat, a drug currently licensed for the treatment of a type of lymphoma, to 'turn on' dormant HIV infected CD4 T-cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Vorinostat

Criteria

Inclusion Criteria:

1. HIV -1 infected adults

2. HIV-1 plasma RNA <50 copies/ml for at least 3 years with at least 2 viral load measures per year, and most recent viral load within 3 months of screening. Episodes of a single HIV plasma RNA 50-199 copies/ml will not exclude participation if the subsequent HIV plasma RNA was <50 copies/ml.

3. Receiving combination antiretroviral therapy (at least 3 agents)

4. In the last 6 months have two CD4 cell count greater than 500 cell/µl

5. Documented subtype B HIV infection

6. Detectable HIV RNA on stored specimen

7. Able to give informed consent

Exclusion Criteria:

1. Any significant acute medical illness in the past 8 weeks.

2. Any evidence of an active AIDS-defining opportunistic infection.

3. Current or recent gastrointestinal disease that may impact the absorption of study drug.

4. Any gastrointestinal surgery that could impact upon the absorption of study drug.

5. Active alcohol or substance use that, in the Investigator's opinion, will prevent adequate compliance with study therapy .

6. Moderate to severe hepatic impairment

7. Hepatic transaminases (AST or ALT) > 3 x upper limit of normal (ULN)

8. Hepatitis B infection as indicated by the presence of Hepatitis B surface antigen or detectable DNA levels in blood.

9. A personal history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (e.g. heart failure).

10. History of malignancy or transplantation, including skin cancers or Kaposi sarcoma

11. History of diabetes mellitus

12. Use of an HIV protease inhibitor.

13. Receipt of immunomodulating agents, immunization or systemic chemotherapeutic agents within 28 days prior to screening.

14. Use of an agent definitely or possibly associated with effects on QT intervals within 2 weeks of screening.

15. Receipt of sodium valproate or other HDAC inhibitor at any time.

16. Women who are pregnant or breastfeeding, or with a positive pregnancy test during screening or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period and for at least 4 weeks before and 4 weeks after the study.

17. Males who are unwilling or unable to use barrier contraception during vaginal intercourse from the time of enrollment and for 12 weeks after participation in the study are also excluded.