- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00336778
Phase 1 Pilot Study of an ART Bridging Regimen in Highly Experienced Patients Unable to Achieve Viral Suppression
A Phase I Pilot Study Of An Antiretroviral Bridging Regimen In Highly Experienced Patients Unable To Achieve Viral Suppression.
We hypothesize that a simple bridging ARV regimen that tends to select for virus with a low replicative capacity may tend to stabilize CD4 cell counts and HIV viral load and might be an option to consider in patients with MDR HIV.
This strategy will provide them with the bridge they desperately need so that they can await the development of new therapies that when used in combination will give them the best chance in achieving complete virologic suppression.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Bridge is a pilot, single-arm, open-label, study to assess the ability of 3 FDA approved anti-retroviral drugs to decrease replication capacity of HIV virus in order to stabilize CD4 cell count and HIV RNA viral loads . All subjects will be prescribed the three-drug combination of lamivudine (3TC) + tenofovir disoproxil fumarate (TDF) + nelfinavir (NLV)The "Bridge Study" is a pilot, study to assess the ability of 3 FDA approved anti-retroviral drugs to decrease replication capacity of HIV virus in order to stabilize CD4 cell count and HIV RNA viral loads. All subjects will receive the three-drug combination of lamivudine (3TC)+tenofovir disoproxil fumarate(TDF)+nelfinavir (NLV)
The study will enroll 12 subjects for a 48 week study. Major entry criteria include: HIV+ Men and women 18 years of age who are currently failing antiretroviral(ARV)therapy with an HIV-1 RNA VL > 10,000 and have failed multiple treatment regimens due to resistance and/or intolerance. Genotype must demonstrate resistance to 3 major classes of ARV's - PI's, NNRTI's, and NRTI's.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21201
- University of Maryland Baltimore, Institute of Human Virology
-
Baltimore, Maryland, Vereinigte Staaten, 21210
- University of Maryland, Institute of Human Virology
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Men and women age > 18 years of age.
- Ability and willingness to give written informed consent.
- HIV-1 infection as documented by any licensed ELISA test kit and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA prior to study entry.
- Patient failed multiple treatment regimens due to development of viral resistance/and or intolerance.
- Patient's provider feels that patient has exhausted currently available treatment options and that it is highly unlikely that a regimen (including one that contains T-20) could be constructed that would result in sustained virologic suppression at this time.
- Evidence of MDR virus (broad 3 class resistance) based on the results of the MDR-HIV qualifying screening genotypic resistance test or a history of a previous genotypic resistance test.
The following screening laboratory values obtained within 30 days prior to study entry:
- HIV-1 RNA or BDNA > 10,000 copies/mL
Exclusion Criteria:
- Active drug or alcohol abuse or dependence which, in the opinion of the investigator, would interfere with adherence to study requirements.
- History of any illness that, in the opinion of the study investigators, might confound the results of the study or pose additional risk in administering study drugs to the subject.
Acute therapy for a serious infection or other serious medical illnesses that are potentially life threatening and require systemic therapy and/or hospitalization.
NOTE: Subjects with a serious infection or serious medical illness must complete acute therapy at least 7 days prior to study entry. Subjects with all other infections or medical illnesses (e.g., vaginitis, folliculitis, bronchitis, pharyngitis, thrush) must receive appropriate therapy prior to study entry (no time restriction).
- Significant Renal Insufficiency - calculated creatinine clearance < 50
- Upon reviewing medication history and genotypic resistance testing, study investigators feel that would be inappropriate to enroll patient in this protocol.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in replication capacity over time from baseline to week 48.
Zeitfenster: 48 weeks
|
Change in viral replication capacity
|
48 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in viral load from baseline to week 48.
Zeitfenster: 48 weeks
|
Change in viral load
|
48 weeks
|
Change in CD4 cell count from baseline to week 48.
Zeitfenster: 48 weeks
|
Change in CD4
|
48 weeks
|
Time to first Grade 3 sign, symptom, or lab abnormality,and/or OI that is at least a grade higher than baseline or a significant increase in viral load from baseline or a greater than 50% decline in CD4 cell count
Zeitfenster: 48 weeks
|
Grade 3 sign, symptom, lab abnormality, OI that has exacerbated.
Or a significant increase in viral load from baseline or a greater than 50% decline in CD4
|
48 weeks
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Robert R Redfield, MD, University of Maryland, College Park
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
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
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
Andere Studien-ID-Nummern
- H-22675
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
-
University of MalayaTeleflexRekrutierungCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Johns Hopkins UniversityAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionVereinigte Staaten
-
National Taiwan University HospitalAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
University of ZurichNoch keine RekrutierungCentral Line-associated Bloodstream Infection (CLABSI) | Katheterbedingte Blutstrominfektion
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandNutricia FoundationAktiv, nicht rekrutierendWachstumsfehler | CLABSI – Central Line Associated Bloodstream InfectionPolen
Klinische Studien zur 3TC, TDF, NLV
-
Gilead SciencesAbgeschlossen
-
Peking Union Medical CollegeUnbekannt
-
The HIV Netherlands Australia Thailand Research...National Health Security Office, Thailand; Swiss HIV Cohort StudyAbgeschlossen
-
University Health Network, TorontoMerck Canada Inc.Anmeldung auf Einladung
-
Juan A. ArnaizUnbekannt
-
International Antiviral Therapy Evaluation CenterGilead SciencesAbgeschlossen
-
National Center for AIDS/STD Control and Prevention...Gilead SciencesAbgeschlossen
-
The HIV Netherlands Australia Thailand Research...Mylan LaboratoriesAbgeschlossen
-
Yu-Jay Corp.Abgeschlossen
-
Peking Union Medical CollegeMinistry of Science and Technology of the People´s Republic of ChinaUnbekanntHIV-Infektionen | Erworbenes ImmunschwächesyndromChina