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Phase 2 Safety and Efficacy Study of Bevirimat Functional Monotherapy in HIV Treatment-Experienced Patients for 2 Weeks*

NCT00511368 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2010-01-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients, who have documented genotypic resistance to at least one major mutation from the IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be monitored for side effects, and the pharmacokinetics of bevirimat will be determined.

Conditions

  • HIV Infections

Interventions

DRUG

matching placebo

DRUG

Bevirimat

Sponsors & Collaborators

  • Myrexis Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Beelen, M.D. · Myrexis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00511368 on ClinicalTrials.gov