Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects

NCT00352911 | Completed Phase 2 Results

• 1 other identifier: VT004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1 activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at each dose level.

Conditions

HIV Infections

Keywords

HIV-1

Outcome Measures

Primary Outcomes (1)

• Mean Log Change in Viral Load From Baseline (Day 1) to Day 56

  Mean log change in HIV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.

  Baseline (Day 1) to Day 56

Study Arms (2)

VGX-410 (Mifepristone)

ACTIVE COMPARATOR

150mg twice daily of VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of VGX-410 for 14 days

Drug: VGX-410 (Mifepristone)

Placebo for VGX-410 (Mifepristone)

PLACEBO COMPARATOR

150mg twice daily of placebo for VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of placebo for VGX-410 for 14 days

Drug: Placebo for VGX-410 (Mifepristone)

Interventions

VGX-410 (Mifepristone) DRUG

Also known as: Mifeprex

VGX-410 (Mifepristone)

Placebo for VGX-410 (Mifepristone) DRUG

Placebo for VGX-410 (Mifepristone)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection
• CD4 cell count \> 200
• Plasma HIV-1 RNA \> 2000 copies/mL and have not received antiretroviral therapy within the 16 weeks prior to entry
• Absolute neutrophil count \> 750/mm3
• Hemoglobin \> 10 g/dL
• Platelet count \> 100,000 mm3
• Creatinine \< 2 X upper limit of normal \[ULN\] (fasting)
• AST (SGOT), ALT (SGPT), and alkaline phosphatase \< 2 X ULN
• Total bilirubin \< 2.5 X ULN
• Albumin \> 3 g/dL
• Serum lipase \< 1.5 X ULN
• Thyroid stimulating hormone (TSH) within normal limits
• Plasma cortisol \> 20 mcg/dL, 30 minutes after cosyntropin administration
• Negative pregnancy test and willing to use effective birth control during the study
• Karnofsky performance score \> 80 within 30 days prior to study entry

You may not qualify if:

• Receipt of antiretroviral treatment within the 16 weeks prior to study entry
• Chronic adrenal failure, adrenal insufficiency, personal or family history of autoimmune endocrine disease, history of active hepatitis B or C, or current treatment for hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Presence of diabetes mellitus
• Pregnancy within 90 days prior to study entry or breast-feeding
• Dysfunctional uterine bleeding within the 12 months prior to study entry
• Any current hormonal contraception or intrauterine device (IUD) use
• Use of drugs that are inhibitors or inducers of metabolism by the cytochrome P450 3A4 within 7 days prior to study entry
• Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry
• Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry
• Any vaccination within 30 days prior to study entry
• Use of systemic cytotoxic chemotherapy within 90 days prior to study entry
• History of allergy to mifepristone or its formulations
• Active drug or alcohol use
• Serious illness requiring systemic treatment and/or hospitalization for at least 14 days prior to study entry
• Weight \< 40 kg or 88 lbs. within 90 days prior to study entry

Sponsors & Collaborators

• VGX Pharmaceuticals, LLC: lead

Study Sites (3)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Veterans Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Mary Giffear, Sr. Clinical Scientist
• Organization: VGX Pharmaceuticals, LLC

mgiffear@inovio.com

267 440 4220

Study Officials

• Princy Kumar, M.D.

  Georgetown University

  PRINCIPAL INVESTIGATOR

• Valerianna Amorosa, MD

  Veteran's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Pablo Tebas, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 17, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 9, 2010
• Results First Posted: January 27, 2010

Record last verified: 2010-03

Locations

US (3)