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

March 4, 2010 updated by: VGX Pharmaceuticals, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) to Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VGX Pharmaceuticals, LLC

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 17, 2006

Study Record Updates

Last Update Posted (Estimate)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 4, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VT004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on VGX-410 (Mifepristone)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe