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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00352911
Recruitment Status : Completed
First Posted : July 17, 2006
Results First Posted : January 27, 2010
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
VGX Pharmaceuticals, LLC

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: VGX-410 (Mifepristone) Drug: Placebo for VGX-410 (Mifepristone) Phase 2

Detailed Description:
VT004 is a double-blind, randomized, placebo-controlled Phase II study of two doses of orally administered mifepristone (VGX-410) (300 and 600 mg) taken as a twice daily (BID) dosage (150mg BID and 300mg BID) in a dose-escalating fashion for 14 days at each dose level to determine antiviral activity and safety in HIV-1-infected participants. At entry, 18 subjects will be randomized in a 5:1 fashion (15 on active drug: 3 on placebo) to receive escalating doses of VGX-410 or matching placebo. Patients will be randomized to receive 300 mg (as 150 mg BID dose) of VGX-410 or matching placebo for 14 days. In patients that complete this dose without significant safety concerns or side effects, the dose will be increased to 600 mg (as 300 mg BID dose) or matching placebo for 14 days. Patients must meet all inclusion/exclusion criteria listed below and be seen on a weekly basis by study personnel while on study drug. Patients must return ~ one month after finishing the study therapy for examination and safety labs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Dose Escalating, Phase II Trial of the Anti -HIV-Activity and Safety of VGX-410 (Mifepristone) in HIV-1 Infected Subjects
Study Start Date : July 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: VGX-410 (Mifepristone)
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)
Other Name: Mifeprex

Placebo Comparator: Placebo for VGX-410 (Mifepristone)
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)



Primary Outcome Measures :
  1. Mean Log Change in Viral Load From Baseline (Day 1) to Day 56 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Men and women >= 18 years of age

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352911


Locations
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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Veterans Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
VGX Pharmaceuticals, LLC
Investigators
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Principal Investigator: 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
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Responsible Party: VGX Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00352911    
Other Study ID Numbers: VT004
First Posted: July 17, 2006    Key Record Dates
Results First Posted: January 27, 2010
Last Update Posted: March 9, 2010
Last Verified: March 2010
Keywords provided by VGX Pharmaceuticals, LLC:
HIV-1
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents