NIH to Study Immune Globulin Impact on AIDS in Infants Born to HIV-Positive Mothers

Researchers hope the HIVIG trial also will provide -more
information about how and when the HIV virus is transmitted from
mother to infant. They also will evaluate the sensitivity and
specificity of early diagnostic tests for identifying the virus in the
newborn. The new tests include polymerase chain reaction (PCR)
detection of HIV DNA and HIV-specific immunological assays.
The study is being chaired by Dr. E. Richard Stiehm of UCLA
Medical Center in Los Angeles and Dr. John Laubert of the University
of Rochester Medical Center in Rochester, New York.
H IVIG is prepared from plasma donated by specially selected
donors who carry the HIV virus but have no symptoms of AIDS. These
donors must have high CD4+ lymphocyte counts to demonstrate that their
immune systems have not yet been compromised by the disease. The
preparation of the HIVIG includes multiple steps to inactivate the HIV
virus.
HIVIG was originally developed and tested under an NHLBI contract
with the New York Blood Center in the late 1980's. The Institute
subsequently sponsored a pilot study with chimpanzees that showed
HIVIG to be effective in preventing infection prior to exposure to the
HIV virus.
The HIVIG trial was originally scheduled to begin in the spring
of 1992, but the original supplier of the HIVIG withdrew. In late
June, NHLBI awarded a contract to the Immunotherapy Division of North
American Biologicals, Inc. to supply the drug.
Pregnant women with confirmed liIV infection who are interested in
participating in the trial can call 1-800-TRIALS-A for more
information.