NCT00000642 - 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)

Duliege AM, Shearer WT, Hammill H, Kline MW, Minkoff HL, Izu A, Ammann A
Transplacental transfer of rCD4-IgG given one week and immediately prior to birth: safety and pharmacokinetics in HIV-1 seropositive pregnant women and their newborn infants. Int Conf AIDS. 1992 Jul 19-24;8(2):B91 (abstract no PoB 3028)
Shearer WT, Duliege AM, Kline MW, Hammill H, Minkoff H, Ammann AJ, Chen S, Izu A, Mordenti J
Transport of recombinant human CD4-immunoglobulin G across the human placenta: pharmacokinetics and safety in six mother-infant pairs in AIDS clinical trial group protocol 146. Clin Diagn Lab Immunol. 1995 May;2(3):281-5.

A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in HIV-1 Seropositive Women During the Last Trimester of Pregnancy and Their Newborns

Details for clinical trial NCT00000642

Clinical trial NCT00000642 - References