ANZCTR - Registration

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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12608000258358

Ethics application status

Approved

Date submitted

19/05/2008

Date registered

21/05/2008

Date last updated

4/11/2009

Type of registration

Retrospectively registered

Titles & IDs

Public title

Clinical study to assess the efficacy and safety of a new antiretroviral drug (MPC-4326) in patients with Human immunodeficiency virus-1 (HIV-1) infection over a period of 14 days to 72 weeks.

Scientific title

title: A Phase II multicenter, open-label, randomized, parallel group, study of MPC-4326 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]

Eudract no: 2007-007152-34

Universal Trial Number (UTN)

Trial acronym

BVM 204

Linked study record

Health condition

Health condition(s) or problem(s) studied:

HIV-1

Condition category

Condition code

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

MPC-4326 (code name) 200mg BID (twice daily) and 300mg BID doses of MPC-4326(tablets). Total duration of bevirimat treatment is 14 days minimum (monothereapy) to 72 weeks maximum (together with an optimised background regiment). Total planned duration of the study is approximately 7 weeks minimum to 81 weeks maximum.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

N/A as neither a comperator nor a placebo will be used.

Control group

Dose comparison

Outcomes

Primary outcome [1]

Evaluate antiretroviral activity and safety administered as momotherapy for 14 days. Primary efficacy endpoint is defined as the mean change in viral load (HIV-1 Ribonucleic acid (RNA) log10 copies/mL0 from baseline at day 15).

Timepoint [1]

At screening, baseline, day 1, 3, 7, 10 and 15.

Secondary outcome [1]

Evaluate antiretroviral activity and safety for 72 weeks. Secondary efficacy endpoint is defined as the mean change in viral load (HIV-1 RNA (Ribonucleic acid) log10 copies/mL from baseline at weeks 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of study visit)

Timepoint [1]

At weeks 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of study visit)

Secondary outcome [2]

Explore the dependence of response on baseline HIV-1 Ribonucleic acid (RNA) levels, genotype and phenotype. Proportion of patients achieving 1.0 log10 reduction in viral load at weeks 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of study visit. Proportion of patients with plasma HIV-1 RNA levels < 400 copies/ml at weeks 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of study visit)

Timepoint [2]

At weeks 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of study visit)

Secondary outcome [3]

To evaluate the emergence of mutations in HIV leading to resistance to MPC-4326 or other components of patient's treatment regimen. Measured as the proportion of patients with treatment-emergent resistant mutations in HIV RT (HIV Reverse Transcriptase), Protease, gp120 and CA-SP1 (Caspase1) at week 2; other timepoints will be analysed according to the profile of results observed.

Timepoint [3]

At screening, baseline, Day1, 3, 7, 10 and 14.

Eligibility

Key inclusion criteria

- documented HIV-1-infection
- a CD4+-lymphocyte count =100 cells/mm3
- a screening plasma HIV-1 RNA value of 2,000 – 500,000 copies/mL.
- treatment-experienced patients must have documented evidence of genotypic resistance in their medical records (at screening) or have a resistance-associated primary mutation at screening by genotype to at least one approved ARV (Anti-retroviral) drug identified on the most recent IAS-USA l(international AIDS society USA) ist of resistance drug mutations
- For treatment-experienced patients: be receiving an antiretroviral therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to initial screening. Note: A washout period of at least 3 days prior to Day 1 of dosing is required.
- treatment-naïve patients: no previous antiretroviral treatment.
- Be able to receive an optimized background regimen

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Current opportunistic infection characteristic of AIDS that is diagnosed within 30 days or is poorly controlled.
- unable to comply with the dosing schedule and protocol evaluations.
- with malabsorption syndromes affecting drug absorption
- A history of seizures or current administration of prophylactic anti-seizure medications.
- history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
- must have laboratory parameters within pre-specified limits.
- Patients who have received treatment with immunomodulating agents within 4 weeks prior to the first dose of study drug.
- Patients who have ever received an HIV immunotherapeutic vaccine.
- Recent use of any recreational drugs (except marijuana), or positive results from a urine screen for substances of abuse
- Bupropion-containing products require at least a 14-day washout period.
- Rifampin or other rifamycin products require at least a 28-day washout period.

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)

Patients will be randomized to either 200 mg BID or 300 mg BID doses of MPC-4326. The randomization will occure central by phone via an interactive voice response system (IVRS), which needs to be called by the site staff for each patient.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Central stratification (IVRS) of the patients by prior antiretroviral use (treatment-experienced vs. treatment-naïve). Equal numbers of patients will be randomized to each treatment group within each stratum.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

18/04/2008

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)

Recruitment postcode(s) [1]

2010

Recruitment postcode(s) [2]

3004

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

Belgium

State/province [2]

Country [3]

Poland

State/province [3]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Myriad Pharmaceuticals Inc.

Address [1]

320 Wakara Way, Salt Lake City, UT 84108

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Myriad Pharmaceuticals Inc.

Address

320 Wakara Way, Salt Lake City, UT 84108

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Limited HREC

Ethics committee address [1]

First Floor
71 Anzac Highway
Ashford SA 5035

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/01/2008

Approval date [1]

05/03/2008

Ethics approval number [1]

B12/08

Summary

Brief summary

The main purpose of this research study is to evaluate the antiretroviral (how effective the drug is at reducing the amount of HIV in the blood) activity of two different doses of MPC-4326 in HIV-1 positive participants and what, if any, side effects there may be through 14 days of dosing. This study will also evaluate the antiretroviral activity and safety of bevirimat in participants who continue treatment with bevirimat as part of combination highly active antiretroviral therapy for up to 72 weeks. We also want to know how much of the drug gets into your blood stream following oral administration. We are asking participants who will start their treatment for the first time (so called naïve (exposed to treatment for the first time) participants) and who are already on treatment (treatment experienced participants) to participate. If you choose to participate in this study and do not intend to continue MPC-4326 treatment past 14 days, you should not expect any medical benefits from taking part in this study and it is even possible that your HIV could worsen during the study. The potential benefit to society may be information gained on the safety and effectiveness of the study treatment for patients in the future. However, if you choose to participate in this study and intend to continue MPC-4326 treatment past 14 days should your viral load reduction in those first 14 days be at least two-thirds or 66.6% as compared with your viral load value at baseline, then you may have medical benefits from taking part in this study. These possible benefits include a persistent viral load reduction and an improvement in the CD4 count (a blood marker of immune system health) that may occur. As this is an experimental medication, the likelihood of these benefits occurring for you is not yet known.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Silvia Gurrieri

Address

Quintiles PTy Limited Level 8&9 67 Albert Avenue Chatswood, NSW 2067

Country

Australia

Phone

+61 2 9016 8245

Fax

+61 2 9016 8106

[email protected]

Contact person for scientific queries

Name

Andrew Beelen

Address

320 Wakara Way, Salt Lake City, UT 84108

Country

United States of America

Phone

+1 801-505-5078

Fax

Not applicable

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically