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Safety and Efficacy Study of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects

NCT00091741 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-07-22

No results posted yet for this study

Summary

The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional antiretroviral (HAART) therapy and for whom no alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is the management of virologic failure and metabolic complications of anti-HIV treatment. Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance remains the single most important reason for virological failure and rapidly limits treatment options.

Conditions

  • HIV Infection

Interventions

DRUG

Etanercept (Enbrel)

Sponsors & Collaborators

  • Advanced Biotherapy, Inc.

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Completion
2004-10-31

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 NCT00091741 on ClinicalTrials.gov