Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks*

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

The purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients, who have documented genotypic resistance to at least one major mutation from the IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be monitored for side effects, and the pharmacokinetics of bevirimat will be determined.

Key facts

Study ID

NCT00511368

Run by

Myrexis Inc.

People needed

92

Starts

2006-04-01

Expected to finish

2008-07-01

Last updated by the study team

2010-01-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female. Females of child-bearing potential, must have a documented negative pregnancy test and be willing to utilize double-barrier contraception through-out the study period.
• Have HIV-1-infection.
• Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of 2,000 - 250,000 copies/ml (inclusive).
• Have documented evidence of genotypic resistance in their medical records (at screening) or have resistance at screening by genotype to any major mutation from the IAS-USA list of resistance drug mutations, defined as: NRTI resistance: M41L, K65R, D67N, K70R, K70E, L74V, Y115F, M184V, M184V/I, L210W, T215Y/F, K219Q/E; NNRTI resistance: L100I, K103N, V106M, V106A/M, V108I, Y181C, Y181C/I, Y188L, Y188C/L/H, G190S/A, G190A, P225H; Major PI resistance: D30N, V32I, L33F, M46I/L, I47V/A, G48V, I50L, I50V, I54M/L, L76V, V82A/F/T, V82A/F/T/S, V82L/T, I84V, N88S, L90M
• Be receiving an antiretroviral therapy regimen containing at least 3 drugs (regimens containing ritonavir must not exceed a total daily dose of 400 mg) which has been unchanged for at least 8 weeks prior to initial screening.
• Be able to receive an optimized background regimen.
• Be free from any acute infection or serious medical illness within 14 days prior to study entry.
• Be informed of the nature of the study and provide written informed consent.
• Be willing to comply with the meal requirements described in the protocol.

You may not qualify if…

• Current opportunistic infection characteristic of AIDS
• Patients unable or unwilling to comply with the dosing schedule and protocol evaluations.
• Patients with malabsorption syndromes affecting drug absorption.
• Patients with systolic blood pressure < 90 mmHg or > 140 mmHg or diastolic blood pressure < 60 mmHg or > 90 mmHg measured in a semi-recumbent position after at least 10 minutes of rest at the screening or qualification visit.
• A history of seizures (excluding pediatric febrile seizures), migraines, cluster and/or chronic headaches, cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
• Patients with abnormal Hemoglobin (< 10.0 g/dL for men and < 9.0 g/dL for women), Neutrophil count (< 1000/mm3), Platelet count (< 100,000/mm3), AST or ALT > 2.5 times the upper limit of normal (patients with a positive HBV surface antigen or HCV antibody test at screening must have AST and ALT no more than 1.5 times the upper limit of normal)
• Patients who have received radiation therapy or cytotoxic chemotherapeutic agents, immunomodulating agents, HIV immunotherapeutic vaccine, an investigational drug or product, or participation in a drug study within 4 weeks prior to the first dose of study drug.
• A history of alcoholism or drug addiction within the past 1 year (unless enrolled in a treatment program and approved by the sponsor). Recent use of any recreational drugs (except marijuana).
• A history of difficulty donating blood or inadequate venous access.
• The donation of blood or plasma within 30 days prior to receiving study medication.
• Note: patients with a CD4 count <100 cells/mm3 will be considered for enrollment following discussion and agreement between the Investigator and the Sponsor.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Colorado Health Science Center — Denver, Colorado, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Whitman-Walker Clinic — Washington D.C., District of Columbia, United States
• Gary Richmond — Fort Lauderdale, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• AIDS Research Consortium of Atlanta, Inc. — Atlanta, Georgia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• The Research Insitute — Boston, Massachusetts, United States
• UNC at Chapel Hill — Chapel Hill, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Miriam Hospital/Brown University — Providence, Rhode Island, United States
• Central Texas Clinical Research — Austin, Texas, United States
• Southwest Infectious Diseases — Dallas, Texas, United States
• University of Texas Medical Branch Internal Medicine — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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