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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00967187




Registration number
NCT00967187
Ethics application status
Date submitted
25/08/2009
Date registered
25/08/2009
Date last updated
4/01/2010

Titles & IDs
Public title
Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
Scientific title
A Phase II Multicenter, Open-label, Randomized, Parallel Group, Study of Bevirimat in HIV-1 Positive Patients to Evaluate the Safety, Efficacy, and Pharmacokinetics of MPC-4326 Administered as Monotherapy for 14 Days and as Part of an Optimized Background Regimen for up to 72 Weeks.
Secondary ID [1] 0 0
BVM Study 204
Secondary ID [2] 0 0
MPC-4326-204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bevirimat dimeglumine
Treatment: Drugs - bevirimat dimeglumine
Treatment: Drugs - bevirimat dimeglumine
Treatment: Drugs - bevirimat dimeglumine

Experimental: MPC-4326 200 mg BID X 14 Days -

Experimental: MPC-4326 300 mg BID X 14 Days. -

Experimental: MPC-4326 200 mg BID X 14 Days -

Experimental: MPC-4326 300 mg BID X 14 Days. -


Treatment: Drugs: bevirimat dimeglumine
Patients will be treated with MPC-4326 200mg monotherapy for 14 days. Once the Day 15 viral load results become available, patients, who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.

Treatment: Drugs: bevirimat dimeglumine
Patients will be treated with MPC-4326, 300 mg monotherapy for 14 days. Once the Day 15 viral load results become available patients who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.

Treatment: Drugs: bevirimat dimeglumine
Patients will be treated with MPC-4326 200mg monotherapy for 14 days. Once the Day 15 viral load results become available, patients, who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.

Treatment: Drugs: bevirimat dimeglumine
Patients will be treated with MPC-4326, 300 mg monotherapy for 14 days. Once the Day 15 viral load results become available patients who achieve at least a 0.5 log10 reduction in viral load by Day 15 will have the option to continue on both MPC-4326 and an optimized background regimen (OBR) through Week 72.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HIV-1 viral load from baseline to day 15
Timepoint [1] 0 0
15 days
Primary outcome [2] 0 0
Change in HIV-1 viral load from baseline to day 15
Timepoint [2] 0 0
15 days
Secondary outcome [1] 0 0
To evaluate safety and tolerability
Timepoint [1] 0 0
72 weeks
Secondary outcome [2] 0 0
To evaluate safety and tolerability
Timepoint [2] 0 0
72 weeks

Eligibility
Key inclusion criteria
- Be at least 18 years of age at the time of screening.

- Have HIV-1-infection.

- Have a CD4+-lymphocyte count=100 cells/mm3

- Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of
2,000 - 500,000 copies/mL (inclusive).

- Be free from any acute infection or serious medical illness within 14 days prior to
study entry.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current opportunistic infection characteristic of AIDS (Category C according to the
CDC Classification System for HIV-1 Infection, 1993 Revised Version, Appendix A) that
is diagnosed within 30 days or is poorly controlled.

- Patients with systolic blood pressure < 90 mmHg or > 140 mmHg or diastolic blood
pressure < 60 mmHg or > 90 mmHg.

- A history of seizures (excluding pediatric febrile seizures) or current administration
of prophylactic anti-seizure medications.

- A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).

- Patients with the following laboratory parameters within 30 days prior to first dose
of study drug: Hemoglobin < 10.0 g/dL for men and < 9.0 g/dL for women Neutrophil
count < 1000/mm3 Platelet count < 50,000/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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
AIDS Research Initiative - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Myrexis Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the antiretroviral activity and safety of 200 mg BID and 300 mg BID doses of
MPC-4326 administered as monotherapy for 14 days to HIV-1 positive patients. Patients with an
initial treatment response will have the option to continue MPC-4326 in combination with an
Optimized Backround Regimen for a maximum of 72 weeks.
Trial website
https://clinicaltrials.gov/show/NCT00967187
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Beelen, MD
Address 0 0
Myrexis Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications