Clinical trial NCT00967187: Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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)

Primary outcomes:
measure: Change in HIV-1 viral load from baseline to day 15
timeFrame: 15 days
Secondary outcomes:
measure: To evaluate safety and tolerability
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: AIDS Research Initiative
state: New South Wales
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
Study officials:
affiliation: Myrexis Inc.
name: Andrew Beelen, MD
role: STUDY_DIRECTOR
References: