NCT00000675 - 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)

Collier A, Katzenstein D, Coombs R, Holodniy M, Mordenti J, Arditti D, Ammann A, Merigan T, Corey L
Safety and pharmacokinetics of intravenous recombinant CD4 immunoadhesin (RCD4-IGG) (AIDS Clinical Trials Group Protocol 121). Int Conf AIDS. 1990 Jun 20-23;6(3):206 (abstract no SB480)
Collier AC, Coombs RW, Katzenstein D, Holodniy M, Gibson J, Mordenti J, Izu AE, Duliege AM, Ammann AJ, Merigan T, et al
Safety, pharmacokinetics, and antiviral response of CD4-immunoglobulin G by intravenous bolus in AIDS and AIDS-related complex. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Oct 1;10(2):150-6.

A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex

Details for clinical trial NCT00000675

Clinical trial NCT00000675 - References