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HIV InfectionsPhase 1NCT00000642

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

A Phase 1 study testing CD4-IgG in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 day to 60 years
Conditions the study is for
HIV Infections, Pregnancy
What is being tested?
CD4-IgG
How many people
30 participants
Where
2 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.
  • Willing and able to sign informed consent.
  • Available for follow-up for at least 3 months.
  • The child should be available for follow-up for at least 1 year after delivery, and preferably longer.

Who cannot join

  • 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.
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  • 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.
  • Corticosteroids.
  • Immunoglobulin preparations.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Regular administration of gamma globulin.
  • Patients with the following are excluded:
  • Serious medical or surgical complication of the pregnancy and/or delivery that required treatment during delivery or that might compromise the health of the mother or fetus.
  • Any HIV-related complications requiring antiretroviral therapy during the pregnancy, including encephalopathy and opportunistic infections.
  • Systemic infection requiring IV therapy in the month prior to enrollment in this study (IV treatment for pyelonephritis is permitted).
  • Prior Medication:
  • Excluded:
  • Recombinant CD4 immunoglobulin G (rCD4-IgG).
  • Excluded within 4 weeks of study entry:
  • 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.
  • Corticosteroids.
  • Immunoglobulin preparations.
  • Prior Treatment:
  • Excluded within 4 weeks of study entry:
  • Radiation therapy.
  • History of poor medical compliance (at the discretion of the investigator). Current illicit drug use.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • SUNY - Brooklyn

    Brooklyn, New York, 11203

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

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.

Part 1: Per the original protocol, a total of six pregnant women were enrolled in Groups A and B. Patients in Group A received rCD4-IgG at the onset of labor, and those in Group B received rCD4-IgG twice per week, beginning 1 week before the expected date of delivery. Newborns were not treated in Part 1 of the study.

AMENDED: In Part 2 of the study, a total of nine pregnant women are enrolled in Groups C, D, and E and receive a higher dose of rCD4-IgG at the onset of labor. If the mother has not delivered 18 hours after rCD4-IgG injection, a second injection at the same dose is administered; daily injections are given thereafter until delivery. The newborns receive 1 of 3 doses of rCD4-IgG daily for the first 5 days of life. Infants are enrolled sequentially to each dose level.

Being tested
CD4-IgG
Keywords
Recombinant Proteins, Pregnancy Trimester, Third, Pregnancy, Pregnancy Complications, Infectious, IgG, Drug Evaluation, Antigens, CD4, AIDS-Related Complex, Immunization, Passive
Medical subject headings
HIV Infections, Pregnancy Complications, Infectious, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD4-IgGDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000642
Sponsor's protocol ID
ACTG 146
Other IDs
D0190g
Status last verified
Oct 2003
First submitted
2 Nov 1999
Last updated
24 Jun 2005
Results posted
No

Publications

  • 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. doi: 10.1128/cdli.2.3.281-285.1995.

    PubMed 7664172

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD4-IgG in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000642, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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