HIV InfectionsPhase 2NCT00352911
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
A Phase 2 study testing VGX-410 (Mifepristone) in people with HIV Infections, run by VGX Pharmaceuticals, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- VGX-410 (Mifepristone)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2006to Nov 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Veterans Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Georgetown University
Washington D.C., District of Columbia, 20007
About this 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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- VGX-410 (Mifepristone), Placebo for VGX-410 (Mifepristone)
- Keywords
- HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGX-410 (Mifepristone)Drug
Also called Mifeprex
Placebo for VGX-410 (Mifepristone)Drug
| Study group | Role | What they receive |
|---|---|---|
| VGX-410 (Mifepristone) | Active comparator | 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 Receives: Drug: VGX-410 (Mifepristone) |
| Placebo for VGX-410 (Mifepristone) | Placebo comparator | 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 Receives: Drug: Placebo for VGX-410 (Mifepristone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- VGX Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Princy Kumar, M.D., Principal investigator, Georgetown UniversityValerianna Amorosa, MD, Principal investigator, Veteran's Hospital of PhiladelphiaPablo Tebas, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352911
- Sponsor's protocol ID
- VT004
- Status last verified
- Mar 2010
- First submitted
- 13 Jul 2006
- Last updated
- 9 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00352911
- Acronym / sponsor ID
- VT004
- Conditions
- HIV Infections
- Keywords
- HIV-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VGX Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 17 Jul 2006 (estimated)
- Results
- Posted 27 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VGX-410 (Mifepristone) | Active comparator | Drug: 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 |
| Placebo for VGX-410 (Mifepristone) | Placebo comparator | Drug: 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VGX-410 (Mifepristone)Also: Mifeprex | Drug | VGX-410 (Mifepristone) |
| Placebo for VGX-410 (Mifepristone) | Drug | Placebo for VGX-410 (Mifepristone) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Princy Kumar, M.D. principal investigator
Georgetown University
Valerianna Amorosa, MD principal investigator
Veteran's Hospital of Philadelphia
Pablo Tebas, M.D. principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VGX-410 (Mifepristone) in people with HIV Infections, run by VGX Pharmaceuticals, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Log Change in Viral Load From Baseline (Day 1) to Day 56 (time frame: Baseline (Day 1) to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2010.