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

Sponsored by:	VGX Pharmaceuticals, Inc.
Information provided by:	VGX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00352911

Purpose

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	Intervention	Phase
HIV Infections	Drug: mifepristone (VGX-410)	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Mifepristone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by VGX Pharmaceuticals, Inc.:

Primary Outcome Measures:

Safety, tolerability, viral load

Estimated Enrollment:	18
Study Start Date:	July 2006

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 b.i.d. dosage 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 (150 mg b.i.d.) or 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 (300 mg b.i.d.) 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352911

Locations

United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Pennsylvania
Veterans Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

VGX Pharmaceuticals, Inc.

Investigators

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

More Information

No publications provided

Study ID Numbers:	VT004
Study First Received:	July 13, 2006
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00352911 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by VGX Pharmaceuticals, Inc.:

HIV-1

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Contraceptive Agents
Hormone Antagonists
Acquired Immunodeficiency Syndrome
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Mifepristone

Contraceptives, Postcoital
Hormones
Antiviral Agents
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Contraceptives, Postcoital, Synthetic
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Infection
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

Retroviridae Infections
Abortifacient Agents, Steroidal
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Mifepristone
Luteolytic Agents
Contraceptives, Postcoital
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009