This study is designed to evaluat the efficacy, safety and tolerance of the combination of HIVIG (administered intrapartum and to the newborn within 12hours of birth), and ZDV (administered intrapartum and to the newborn for 6 weeks following delivery), compared to IVIG and ZDV, administered similarly, for the reduction of HIV infection in infants born to HIV-infected women who are receiving ZDV during pregnancy for medical indications. The secondary aims of this study are: To establish the pharmacokinetics of the HIVIG preparation by measuring HIV-specific antibody (quantitative p24 antibody) in a small subset of pregnant women. To evaluate maternal virologic and immunologic factors involved in HIV transmission from mother or infant, and the influencea of HIVIG on HIV perinatal transmission. To compare other methods for detection of HIV including polymerase chain reaction (PCR) detection of HIV DNA and placental RNA in situ hybridization to HIV culture. To evaluate the response of selected laboratory markers of HIV infection (plasma viremia and cell culture, p24 antign, and CD4 count) and HIV- associated symptoms during pregnancy and through 78 weeks postpartum in women receiving HIVIG compared to those receiving standard IVIG. To evaluate the safety and tolerance of HIVIG when administered in combination with ZDV to pregnant hIV-infected women. To evaluate the safety and tolerance of HIVIG when administered in combination with ZDV (given for 6 weeks after delivery) to infants with perinatal HIV exposure.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000040-38A1
Application #
6274487
Study Section
Project Start
1998-04-15
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
38
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Pennsylvania
Department
Type
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Khalili, Mandana; Shuhart, Margaret C; Lombardero, Manuel et al. (2018) Relationship Between Metabolic Syndrome, Alanine Aminotransferase Levels, and Liver Disease Severity in a Multiethnic North American Cohort With Chronic Hepatitis B. Diabetes Care 41:1251-1259
Thomas, Bernadette; Matsushita, Kunihiro; Abate, Kalkidan Hassen et al. (2017) Global Cardiovascular and Renal Outcomes of Reduced GFR. J Am Soc Nephrol 28:2167-2179
Ojiro, Keisuke; Qu, Xiaowang; Cho, Hyosun et al. (2017) Modulation of Hepatitis C Virus-Specific CD8 Effector T-Cell Function with Antiviral Effect in Infectious Hepatitis C Virus Coculture Model. J Virol 91:
Di Bisceglie, A M; Lombardero, M; Teckman, J et al. (2017) Determination of hepatitis B phenotype using biochemical and serological markers. J Viral Hepat 24:320-329
Lok, A S; Ganova-Raeva, L; Cloonan, Y et al. (2017) Prevalence of hepatitis B antiviral drug resistance variants in North American patients with chronic hepatitis B not receiving antiviral treatment. J Viral Hepat 24:1032-1042
Leonard, Mary B; Shults, Justine; Long, Jin et al. (2016) Effect of Low-Magnitude Mechanical Stimuli on Bone Density and Structure in Pediatric Crohn's Disease: A Randomized Placebo-Controlled Trial. J Bone Miner Res 31:1177-88
Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N et al. (2016) National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 65:3418-3428
Evon, Donna M; Wahed, Abdus S; Johnson, Geoffrey et al. (2016) Fatigue in Patients with Chronic Hepatitis B Living in North America: Results from the Hepatitis B Research Network (HBRN). Dig Dis Sci 61:1186-96
Park, Jang-June; Wong, David K; Wahed, Abdus S et al. (2016) Hepatitis B Virus--Specific and Global T-Cell Dysfunction in Chronic Hepatitis B. Gastroenterology 150:684-695.e5
Hering, Bernhard J; Clarke, William R; Bridges, Nancy D et al. (2016) Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 39:1230-40

Showing the most recent 10 out of 423 publications