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

NCT00511368 | Completed Phase 2 DMC

• 1 other identifier: PA103001-04 Study 203
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

HIV Infections

Keywords

HIV; treatment experienced; AIDS

Outcome Measures

Primary Outcomes (1)

• HIV-1 RNA change from baseline over the first 14 days of study

  14 days

Secondary Outcomes (1)

• safety and tolerability; pharmacokinetics

  14 days

Study Arms (2)

1

PLACEBO COMPARATOR

placebo

Drug: matching placebo

2

EXPERIMENTAL

Bevirimat

Drug: matching placebo; Drug: Bevirimat

Interventions

matching placebo DRUG

Also known as: PA103001-04, PA-457N

1; 2

Bevirimat DRUG

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Myrexis Inc.: lead

Study Sites (18)

UCLA Medical Center

Los Angeles, California, 90035, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

University of Colorado Health Science Center

Denver, Colorado, 80262, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Whitman-Walker Clinic

Washington D.C., District of Columbia, 20037, United States

Location

Gary Richmond

Fort Lauderdale, Florida, 33316, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

AIDS Research Consortium of Atlanta, Inc.

Atlanta, Georgia, 30308, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

The Research Insitute

Boston, Massachusetts, 02215, United States

Location

UNC at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Miriam Hospital/Brown University

Providence, Rhode Island, 02906, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Southwest Infectious Diseases

Dallas, Texas, 75204, United States

Location

University of Texas Medical Branch Internal Medicine

Galveston, Texas, 77210-4786, United States

Location

Related Links

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MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

bevirimat

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Andrew Beelen, M.D.

  Myrexis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 3, 2007
• Study Start: April 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

US (18)