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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VGX-410 (Mifepristone)
Placebo for VGX-410 (Mifepristone)
Sponsored by
VGX Pharmaceuticals, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University
  • University of Pennsylvania
  • Veterans Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

VGX-410 (Mifepristone)

Placebo for VGX-410 (Mifepristone)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2006
Last Updated
March 4, 2010
Sponsor
VGX Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00352911
Brief Title
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
VGX Pharmaceuticals, LLC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VGX-410 (Mifepristone)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo for VGX-410 (Mifepristone)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
VGX-410 (Mifepristone)
Other Intervention Name(s)
Mifeprex
Intervention Type
Drug
Intervention Name(s)
Placebo for VGX-410 (Mifepristone)
Primary Outcome Measure Information:
Title
Mean Log Change in Viral Load From Baseline (Day 1) to Day 56
Description
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.
Time Frame
Baseline (Day 1) to Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Princy Kumar, M.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valerianna Amorosa, MD
Organizational Affiliation
Veteran's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo Tebas, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Veterans Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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