Oral Auranofin for Reduction of Latent Viral Reservoir in Patients With HIV Infection

NCT02176135 | Withdrawn Phase 1 DMC

• 1 other identifier: AUR-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the study is to evaluate the safety of oral auranofin, a gold compound, in patients with HIV infection whose viral load has been suppressed by antiretroviral therapy for no less than 3 years and have a CD4+ cell count over 500 cells/uL

Conditions

HIV

Keywords

HIV; HAART suppressed; Auranofin; HIV latent reservoir

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Adverse event frequency and severity per NIAID ACTG grading tables

  12 weeks treatment and 8 weeks post-therapy

Secondary Outcomes (1)

• Change from baseline in measures of the HIV latent reservoir during auranofin therapy

  12 weeks therapy and 8 weeks post-therapy

Study Arms (1)

Dose escalation

EXPERIMENTAL

Auranofin 3 to 6 mg/day oral administration for 12 weeks

Drug: Auranofin

Interventions

Auranofin DRUG

3 mg tablets

Also known as: Ridaura

Dose escalation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or female, between 18 and 55 years of age.
• Stable dose of ART (defined as at least 2 nucleoside/nucleotide reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor, integrase inhibitor, or a protease inhibitor) for at least 2 years from study consent and with no modifications expected during the study.
• HIV plasma viral load \<50 copies/ml for at least 3 years with several measurements per year and most recent viral load within 3 months of screening.8
• No previous failure of ART, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (\<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying ART are acceptable.
• Did not experience AIDS defining event
• Two CD4+ T cell counts greater than 500 cell/µl in the six months prior to screening
• Able (in the Investigators' opinion) and willing to comply with all study requirements.

You may not qualify if:

• Contraindication to auranofin therapy, including congestive heart failure, renal dysfunction, history of blood dyscrasias; History of gold induced disorders (e.g. necrotising enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasia or other sever hematologic disorders), porphyria; History of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds.
• Treatment with nucleoside/nucleotide analogs with higher risk of mitochondrial toxicity: zidovudine (ZDV), Stavudine (d4T), didanosine (ddI), di-deoxy-cytidine (ddC) or abacavir (ABC).
• Presence of clinically significant skin/mucosal disease such as hives or dermatitis, pruritus or rash, eczema, stomatitis or conjunctivitis
• Significant acute medical illness in the past 4 weeks
• Inflammatory bowel disease, Crohn's disease or ulcerative colitis
• Current or recent (i.e. within 2 weeks) gastrointestinal disease or GI disturbances, including vomiting, abdominal pain, diarrhea, which may impact the absorption of the investigational drug
• History of gastrointestinal surgery that could impact upon the absorption of Auranofin
• Scheduled elective surgery or other procedures requiring general anesthesia during the study
• Participant has the following laboratory values within 2 weeks before starting the investigational drug (laboratory tests may be repeated, as clinically indicated, to obtain acceptable values before failure at screening is concluded)
• Known hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood
• Receipt of immunomodulating therapy, EPO or G-CSF, immunization or systemic chemotherapeutic agents within 12 weeks prior to study entry
• Anticipated requirement for treatment with drugs that may interfere with auranofin as outlined in Appendix 7.
• Receipt of RBC or platelet transfusion or receipt of cell product within 24 weeks prior to study entry
• Insulin dependent diabetes
• Systemic Lupus Erythematosus (SLE)

Sponsors & Collaborators

• Vaccine and Gene Therapy Institute, Florida: lead
• University of Miami: collaborator

Study Sites (1)

University of Miami - AIDS Clinical Research Unit

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Auranofin

Intervention Hierarchy (Ancestors)

Aurothioglucose; Organogold Compounds; Organometallic Compounds; Organic Chemicals

Study Officials

• Patrick D Yeramian, MD

  Vaccine and Gene Therapy Institute, Florida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

US (1)