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
2 other identifiers
interventional
30
1 country
2
Brief Summary
Part 1: To determine both the safety, tolerance, and pharmacokinetic profile (blood levels) of recombinant CD4 immunoglobulin G (rCD4-IgG) by intravenous bolus administration (given through the vein) in women with HIV infection who are in their third trimester (last three months of pregnancy). To determine the safety of maternal/fetal transfer of rCD4-IgG in infants born to mothers entered into the study. To obtain a preliminary indication of the antiviral and immunologic effects of rCD4-IgG in HIV seropositive pregnant women and their newborns. AMENDED: Part 2: To determine the safety profile of rCD4-IgG in HIV-1-infected women at the onset of labor and in their newborns. To determine the extent of placental transfer of rCD4-IgG when administered to the mother at onset of labor. To determine the pharmacokinetics of rCD4-IgG in newborns. To obtain preliminary evidence of the ability of rCD4-IgG to prevent intrapartum transmission of HIV-1 from mother to fetus. An agent that can prevent HIV infection is desirable for those at risk of infection as well as in the pregnant female and newborn populations. Such an agent may help prevent the progression of the disease in infants and children in early stages of infections. In theory, rCD4-IgG has antiviral effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
October 1, 2003
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Iron, multivitamins, short courses of treatment for correctable medical problems (e.g., urinary tract infection), oral trimethoprim/sulfamethoxazole (TMP/SMX) or aerosolized pentamidine for prophylaxis of Pneumocystis carinii pneumonia (PCP), prophylactic antifungal therapy, or isoniazid (INH) therapy.
- Acetaminophen.
- Other supportive therapy (blood and blood products, vaginal creams, antiemetics, antidiarrheals, cough medicines).
- Specific agents used during delivery, such as oxytocic agents or anesthetics. Participation in this protocol will not prevent a newborn from receiving any medication.
- Concurrent Treatment:
- Allowed:
- Blood and blood product transfusions.
- Gamma globulin as prophylaxis against infection with varicella virus and hepatitis virus, or RhoGAM in case of maternal-fetal incompatibility.
- Risk Behavior:
- Allowed:
- Illicit drug use.
- Patients must be:
- In their third trimester of pregnancy, or join the study with their newborn children.
- +3 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Medical complications including, but not limited to, insulin dependent diabetes mellitus (IDDM), hypertensive disorders such as severe pre-eclampsia, eclampsia, chronic hypertension, cardiovascular disease including rheumatic or congenital heart disease, collagen vascular disease, endocarditis, and renal disease.
- Hematological conditions including, but not limited to, hemoglobinopathies, coagulopathy, idiopathic thrombocytopenic purpura (ITP), and maternal-fetal blood incompatibilities with isoimmunization (e.g., Rh-negative mother with a positive indirect Coomb's test at any time during this pregnancy).
- Neurological disease(s) including seizure disorders.
- Bronchopulmonary diseases, such as severe asthma.
- Evidence of fetal intolerance of the intrauterine environment.
- Concurrent Medication:
- Excluded:
- Antiretroviral agents:
- Suramin, ribavirin, HPA23, phosphonoformate, ansamycin, zidovudine (AZT), didanosine (ddI), or dideoxycytidine (ddC).
- Other antiviral drugs, including acyclovir or ganciclovir.
- Immunomodulating agents:
- Interleukin 2, interferons, thymic hormones, or other agents.
- Cytolytic chemotherapeutic agents.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
SUNY - Brooklyn
Brooklyn, New York, 11203, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030, United States
Related Publications (2)
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)
BACKGROUNDShearer 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. doi: 10.1128/cdli.2.3.281-285.1995.
PMID: 7664172BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- PREVENTION
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2003-10