Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks*
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00511368 |
Recruitment Status
:
Completed
First Posted
: August 3, 2007
Last Update Posted
: January 20, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: matching placebo Drug: Bevirimat | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Dose-escalating, P-C, D-B, Parallel Group Study in HIV Treatment-experienced Patients to Evaluate the Safety, Tolerability and Efficacy of PA103001-04 Administered as Functional Monotherapy for 14 Days *(PART B) |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
placebo
|
Drug: matching placebo
Other Names:
|
Experimental: 2
Bevirimat
|
Drug: matching placebo
Other Names:
Drug: Bevirimat
|
- HIV-1 RNA change from baseline over the first 14 days of study [ Time Frame: 14 days ]
- safety and tolerability; pharmacokinetics [ Time Frame: 14 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511368
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90035 | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 | |
United States, Colorado | |
University of Colorado Health Science Center | |
Denver, Colorado, United States, 80262 | |
United States, District of Columbia | |
George Washington University Medical Center | |
Washington, District of Columbia, United States, 20037 | |
Whitman-Walker Clinic | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Gary Richmond | |
Fort Lauderdale, Florida, United States, 33316 | |
Orlando Immunology Center | |
Orlando, Florida, United States, 32803 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta, Inc. | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
The Research Insitute | |
Boston, Massachusetts, United States, 02215 | |
United States, North Carolina | |
UNC at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Drexel University College of Medicine | |
Philadelphia, Pennsylvania, United States, 19102 | |
United States, Rhode Island | |
Miriam Hospital/Brown University | |
Providence, Rhode Island, United States, 02906 | |
United States, Texas | |
Central Texas Clinical Research | |
Austin, Texas, United States, 78705 | |
Southwest Infectious Diseases | |
Dallas, Texas, United States, 75204 | |
University of Texas Medical Branch Internal Medicine | |
Galveston, Texas, United States, 77210-4786 |
Study Director: | Andrew Beelen, M.D. | Myrexis Inc. |
Additional Information:
Responsible Party: | Andrew Beelen, M.D, Sr. Director Clinical Research, Myriad Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00511368 History of Changes |
Other Study ID Numbers: |
PA103001-04 Study 203 |
First Posted: | August 3, 2007 Key Record Dates |
Last Update Posted: | January 20, 2010 |
Last Verified: | January 2010 |
Keywords provided by Myrexis Inc.:
HIV treatment experienced AIDS |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |