Completed

rCD4-IgG for HIV Prevention in Pregnant Women and Newborns

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What is being tested

CD4-IgG

Drug
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00000642
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPregnancy ComplicationsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexPregnancy Complications, InfectiousHIV Infections

Criteria

11 inclusion criteria required to participate
Concurrent Medication: Allowed - Acetaminophen
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
Concurrent Medication: Allowed - Other supportive therapy (blood and blood products, vaginal creams, antiemetics, antidiarrheals, cough medicines)
Concurrent Medication: Allowed - 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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26 exclusion criteria prevent from participating
Co-existing Condition: Patients with the following conditions or symptoms are excluded: Bronchopulmonary diseases, such as severe asthma
Co-existing Condition: Patients with the following conditions or symptoms are excluded: Evidence of fetal intolerance of the intrauterine environment
Co-existing Condition: Patients with the following conditions or symptoms are excluded: 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)
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
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

SUNY - Brooklyn

Brooklyn, United StatesOpen SUNY - Brooklyn in Google Maps

Texas Children's Hosp / Baylor Univ

Houston, United States
Completed2 Study Centers