A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection
To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain preliminary indication of the antiviral and immunologic effects of recombinant CD4 immunoglobulin G (CD4-IgG).
CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date.
Aperçu de l'étude
Description détaillée
CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date.
Patients receive one intravenous injection the first week, followed by a 6 day washout period and then intravenous injections on a twice weekly basis from week 2 to week 12. The dose per injection may vary. The study evaluates 2 groups: (1) Children 3 months to 5 years of age; (2) Infants 0-3 months of age.
Type d'étude
Inscription
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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San Diego, California, États-Unis, 92103
- UCSD Treatment Ctr
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Florida
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Miami, Florida, États-Unis, 33136
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, États-Unis, 60612
- Cook County Hosp
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112
- Tulane Univ Med School
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New York
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Great Neck, New York, États-Unis, 11021
- North Shore Univ Hosp
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New York, New York, États-Unis, 10032
- Columbia Univ Babies' Hosp
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Texas
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Houston, Texas, États-Unis, 77030
- Texas Children's Hosp / Baylor Univ
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria
Patients must have the following:
- HIV-1 infection, or if less than 15 months old, born to mother with HIV-1 infection.
- Legally qualified guardian with the ability to sign a written, informed consent form.
- Willingness to abstain from all other experimental therapy for HIV-1 infection during the first 12 weeks of the study period.
- Anticipated life expectancy of at least 3 months.
Prior Medication:
Allowed:
- Prophylactic anti-Pneumocystis carinii pneumonia (PCP) or antifungal therapy.
- Gamma globulin as prophylaxis for measles and varicella.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Past or present history of neurological abnormalities including withdrawal syndrome or seizures.
- Past or present history of any serious active opportunistic infection including Pneumocystis carinii pneumonia (PCP).
- Echocardiogram values > 2 standard deviations from normal.
- Hematologic, renal, or hepatic insufficiency.
Concurrent Medication:
Excluded:
- Zidovudine (AZT).
- Intravenous gamma globulin (IVIG) except as prophylaxis for measles and varicella.
- Cancer chemotherapy.
- Corticosteroids.
- Other known immunomodulatory agents.
- Other experimental therapy not specifically allowed.
Patients with the following are excluded:
- Hematologic, renal, or hepatic insufficiency.
- Past or present history of any serious active opportunistic infection.
Prior Medication:
Excluded for a minimum of 3 weeks prior to study entry:
- Zidovudine (AZT).
- Intravenous gamma globulin (IVIG).
- Cancer chemotherapy.
- Immunomodulatory agents.
- Acyclovir and other experimental therapy.
Risk Behavior:
Excluded:
- Patients born to substance abusing mothers (including alcohol) during the pregnancy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: W Shearer
- Chaise d'étude: R Yogev
Publications et liens utiles
Publications générales
- Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)
- Shearer WT, Israel RJ, Starr S, Fletcher CV, Wara D, Rathore M, Church J, DeVille J, Fenton T, Graham B, Samson P, Staprans S, McNamara J, Moye J, Maddon PJ, Olson WC. Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team. J Infect Dis. 2000 Dec;182(6):1774-9. doi: 10.1086/317622. Epub 2000 Oct 27.
Dates d'enregistrement des études
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ACTG 139
- D0172g
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