Phase 2
Completed N=19
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
Source: ClinicalTrials.gov NCT00352911 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Jan 2010
Primary outcomePrimary: Mean Log Change in Viral Load From Baseline (Day 1) to Day 56 — 0.18; 0.42 copies/mL on log scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Log Change in Viral Load From Baseline (Day 1) to Day 56 |
0.18; 0.42 | — |
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 3 g/dL
- Serum lipase 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
Data sourced from ClinicalTrials.gov (NCT00352911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.