- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00000663
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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California
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San Diego, California, Forente stater, 92103
- UCSD Treatment Ctr
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Florida
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Miami, Florida, Forente stater, 33136
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Cook County Hosp
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Tulane Univ Med School
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New York
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Great Neck, New York, Forente stater, 11021
- North Shore Univ Hosp
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New York, New York, Forente stater, 10032
- Columbia Univ Babies' Hosp
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Texas
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Houston, Texas, Forente stater, 77030
- Texas Children's Hosp / Baylor Univ
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: W Shearer
- Studiestol: R Yogev
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACTG 139
- D0172g
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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