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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-01-31

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.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevirimat 200 mg twice daily, 15 days

Group Type EXPERIMENTAL

Bevirimat

Intervention Type DRUG

Bevirimat 300 mg once daily, 15 days

Group Type EXPERIMENTAL

Bevirimat

Intervention Type DRUG

Bevirimat 400 mg once daily, 15 days

Group Type EXPERIMENTAL

Bevirimat

Intervention Type DRUG

Interventions

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Bevirimat

Intervention Type DRUG

Other Intervention Names

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MPC-4326

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No