A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.

Official Title
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A Phase II Multicenter, Open-label, Randomized, Parrallel Group Study to Assess the Pharmacokinetics of Bevirimat (BVM) 100 mg Tablets Administered to HIV-1 Positive Patients for 15 Days

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Drug: Bevirimat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have documentation of HIV-1 infection in their medical records (documentation of any prior plasma viremia is acceptable). Have a CD4+ lymphocyte count >/= 100 cells/mm3. Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of <400 copies/mL. Be receiving an ARV therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to screening, and which is to be continued through Day 15 of the study. Be informed of the nature of the study and provide written informed consent. Be legally competent and able to communicate effectively with study personnel. Be able and willing to comply with outpatient visits. Exclusion Criteria: Presence of any acute illness within 14 days prior to study entry. Presence of any AIDS-related opportunistic infection (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version) that is unstable in the Investigator's opinion or diagnosed in the 30 days prior to study entry. Patients who are, in the opinion of the Investigator, unable to comply with the dosing schedule and protocol evaluations. Patients with malabsorption syndromes affecting drug absorptions (e.g. Crohn's disease, chronic pancreatitis). Patients with systolic blood pressure < 90 mmHg or > 160 mmHg or diastolic blood pressure < 50 mmHg or > 110 mmHg. A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medication for the indication of seizures or seizure-related conditions. A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA). Patients who have received radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to first dose of study drug. Patients who have received treatment with immunomodulating agents such as IL-2, alpha-interferon, beta-interferon, or gamma-interferon within 4 weeks prior to first dose of study drug. Receipt of an investigational drug or product, or participation in a drug study within a period of 30 days prior to receiving study medication. Bupropion-containing products require at least a 14-day washout period and will not be approved for co-administration. Rifampin or other rifamycin products require at least a 28-day washout period and will not be approved for coadministration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevirimat 200 mg twice daily, 15 days<br> | Drug: Bevirimat<br> <br> * Other names: MPC-4326;|
| Experimental: Bevirimat 300 mg once daily, 15 days<br> | Drug: Bevirimat<br> <br> * Other names: MPC-4326;|
| Experimental: Bevirimat 400 mg once daily, 15 days<br> | Drug: Bevirimat<br> <br> * Other names: MPC-4326;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days |  | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure bevirimat blood plasma concentrations following the administration of bevirimat 2 X 100 mg, 3 x 100 mg, or 4 x 100 mg tablets after a standardized meal. The pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life will be calculated. |  | Day 15 |