Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
VGX Pharmaceuticals, Inc. |
---|---|
Information provided by: | VGX Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00352911 |
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 |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | July 2006 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 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 |
HIV-1 |
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 |
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 |