NCT00091741 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

De SK, Devadas K, Notkins AL
Elevated levels of tumor necrosis factor alpha (TNF-alpha) in human immunodeficiency virus type 1-transgenic mice: prevention of death by antibody to TNF-alpha. J Virol. 2002 Nov;76(22):11710-4.
Zagury D, Burny A, Gallo RC
Toward a new generation of vaccines: the anti-cytokine therapeutic vaccines. Proc Natl Acad Sci U S A. 2001 Jul 3;98(14):8024-9.

A Phase I Pilot Study to Evaluate Safety and Efficacy of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects Who Are in Virologic Failure and Who Have Failed to Respond to Standard Antiretroviral Therapy

Details for clinical trial NCT00091741

Clinical trial NCT00091741 - References