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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Advanced Biotherapy, Inc.
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.)