- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00000876
Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
Phase I/II Trial of CD4-IgG2 in HIV-Infected Children
CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells (cells of the immune system that fight infection). The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective.
HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help the virus invade the body. CD4 cells are killed or disabled during this process of HIV replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts become very low, the body is unable to defend itself, and HIV infection develops into AIDS. The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children.
Studienübersicht
Detaillierte Beschreibung
Since CD4 is the high-affinity receptor for HIV-1, molecules such as CD4-IgG2, which incorporate the gp120 binding region of CD4, have the potential to bind and neutralize all strains of the virus. [AS PER AMENDMENT 4/25/00: Study results have demonstrated that the product is safe in children, well tolerated, and may have antiviral properties. With these encouraging results in hand, an extra cohort has been added using twice the dose of rCD4-IgG2 as in Cohort I.]
The study is conducted in two parts. In Part 1 patients receive a single dose of CD4-IgG2 intravenously at 1 of 4 dose levels. A minimum of 3 patients are treated at a given dose level. If none of these 3 patients experience Grade 3 or 4 toxicity, patients are escalated to the next dose level. If any of these 3 patients have life-threatening toxicities or if more than 1 of these 3 patients experience non-life-threatening Grade 3 or 4 toxicities, escalation stops and the prior dose (if any) is considered the maximum tolerated dose (MTD). If 1 of these 3 patients experiences non-life-threatening Grade 3 or 4 toxicities, 3 additional patients are treated at this dose level. If 1 or more of these 3 additional patients has Grade 3 or 4 toxicity, escalation stops. If none of these 3 additional patients has Grade 3 or 4 toxicity, patients are escalated to the next dose level.
Part 2 provides additional data on the safety, toxicity and pharmacokinetics of CD4-IgG2 when given in multiple doses. Patients receive the highest safe dose (MTD) as established in Part 1. Treatment is given intravenously once weekly at Weeks 0, 1, 2, and 3. If insufficient activity is seen at this dose level, 6 additional patients will be enrolled at a higher dose level. Patients who participate in Part 1 may enroll in Part 2 provided they are followed for at least 3 months and meet inclusion criteria for Part 2. If any patient experiences a life-threatening condition due to CD4-IgG2, the study will stop. [AS PER AMENDMENT 4/25/00: Cohort II receives twice the dose of Cohort I intravenously once weekly at Weeks 0, 1, 2 and 3. Pharmacokinetic samples are obtained at pre-dose and 1 hour after the doses are administered at Weeks 0, 1, and 2; and pre-dose, 1 hour, 24 hours, and Days 3, 7, and 14 after the dose are administered at Week 3. An overnight stay in the hospital is recommended for the first 24 hours. At Weeks 0, 1, 2, and 3, virology testing including HIV-1 RNA is performed with each infusion of CD4-IgG. Follow-up monitoring of patients is done once a month for 4 months for patients in Cohort II.]
Studientyp
Einschreibung
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
California
-
Long Beach, California, Vereinigte Staaten, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
-
Los Angeles, California, Vereinigte Staaten, 900276016
- Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
-
Los Angeles, California, Vereinigte Staaten, 90090-1752
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
-
Orange, California, Vereinigte Staaten, 92868
- Children's Hosp. of Orange County
-
San Francisco, California, Vereinigte Staaten, 941430105
- UCSF Pediatric AIDS CRS
-
-
District of Columbia
-
Washington, District of Columbia, Vereinigte Staaten, 20010-2970
- Children's National Med. Ctr. Washington DC NICHD CRS
-
-
Florida
-
Jacksonville, Florida, Vereinigte Staaten, 32209
- Univ. of Florida Jacksonville NICHD CRS
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- Texas Children's Hosp. CRS
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
Children may be eligible for this study if they:
- Are HIV-positive.
- Are 2-12 years old and have consent of parent or legal guardian.
- Have HIV levels of 10,000 copies/ml or more on at least 2 occasions and 30 days apart (Part 2 only).
- Have been on stable, unchanged anti-HIV therapy for 3 months before study entry.
Exclusion Criteria
Children will not be eligible for this study if they:
- Have an active opportunistic (HIV-related) infection.
- Are pregnant.
- Are taking certain medications.
- Have received any vaccinations within 30 days prior to study entry.
- Have a heart problem that would affect their ability to take part in the study. (This study has been changed. The original version didn't mention heart problems.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Maskierung: Keine (Offenes Etikett)
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Stuart Starr
- Studienstuhl: William Shearer
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
- Physiologische Wirkungen von Arzneimitteln
- Immunologische Faktoren
- CD4-Immunadhäsine
Andere Studien-ID-Nummern
- PACTG 351
- 10699 (DAIDS ES Registry Number)
- ACTG 351
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur HIV-Infektionen
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
University of MalayaTeleflexRekrutierungCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
Johns Hopkins UniversityAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionVereinigte Staaten
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
National Taiwan University HospitalAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandNutricia FoundationAktiv, nicht rekrutierendWachstumsfehler | CLABSI – Central Line Associated Bloodstream InfectionPolen
-
Boston Children's HospitalSterileCare Inc.Anmeldung auf EinladungZentrale Linienkomplikation | Central Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
Klinische Studien zur CD4-IgG2
-
Genentech, Inc.AbgeschlossenHIV-InfektionenVereinigte Staaten
-
Singh, Ranjan Kumar, M.D.AbgeschlossenHIV-Infektionen | Tuberkulose | Kryptokokkose | Leishmaniose | Candidiasis, Ösophagus | ToxoplasmoseIndien
-
Genentech, Inc.AbgeschlossenHIV-InfektionenVereinigte Staaten
-
iCell Gene TherapeuticsPeking University Shenzhen Hospital; iCAR Bio Therapeutics Ltd.RekrutierungRefraktäres T-Zell-Lymphom | T-Zell-Lymphom im RückfallChina
-
University of PennsylvaniaAbgeschlossen
-
Genentech, Inc.AbgeschlossenHIV-Infektionen | Immunthrombozytopenische Purpura ( ITP )Vereinigte Staaten
-
National Institute of Allergy and Infectious Diseases...Genentech, Inc.Abgeschlossen
-
Bacchetta, Rosa, MDFood and Drug Administration (FDA); California Institute for Regenerative Medicine...Rekrutierung
-
National Institute of Allergy and Infectious Diseases...Genentech, Inc.Abgeschlossen
-
Assiut UniversityUnbekanntImmunthrombozytopenie