Status:
COMPLETED
Safety and Efficacy Study of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Advanced Biotherapy, Inc.
Conditions:
HIV Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 t...
Detailed Description
I. Background and Rationale: The greatest challenge faced by HIV-treating clinicians today is the management of virologic failure and metabolic complications of anti-HIV treatment. Treatment failure ...
Eligibility Criteria
Inclusion
- Age between 18 and 60 years.
- Confirmed diagnosis of HIV-1 infection, as documented by any licensed ELISA test kit, and confirmed by Western blot at any time prior to study entry, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA.
- Prior antiretroviral therapy, defined as: Receipt of at least two separate protease inhibitor (PI)-containing regimens (minimum 12 weeks) which was changed because of virological failure (per subject or physician history) or detectable plasma HIV-1 RNA AND A minimum of 1 year total prior antiretroviral experience.
- A CD4 count of \> 200.
- Signed a written informed consent prior to initiation of any study related procedures.
- All subjects should continue taking the same antiretroviral regimen between the screening and entry visits.
Exclusion
- History or suspicion of active tuberculosis or a prior history of being treated for tuberculosis.
- Documented history of sepsis.
- Known hypersensitivity to ENBREL or any of its components.
- Patients on concomitant immunosuppressive therapy, e.g., steroids, cyclosporine, etc.
- Any condition which may interfere with the trial, including the patient's mental ability to follow protocol instructions.
- Patients with heart failure or a history of congestive heart failure.
- Renal insufficiency (creatinine \>2.5 mg/dL)
- Women of child bearing potential who are not willing to avoid pregnancy for the duration of the study and 3 months thereafter.
- Inability or unwillingness to take appropriate prophylaxis for opportunistic infections (i.e., PCP toxoplasmosis, etc.)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2004
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00091741
End Date
October 1 2004
Last Update
July 22 2009
Active Locations (1)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20057