- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02184299
Study of Nevirapine and Prednisone to Determine the Safety and Effectiveness in Preventing Nevirapine Associated Rash in Human Immunodeficiency Virus (HIV) Infected Patients
A Multicenter, Randomized, Open-label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of This Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Male or female patients of any ethnic group between the ages of 18 and 65 years of age
- Women of childbearing potential had to utilize adequate birth control to prevent pregnancy for study duration. Due to possibility that study drugs could alter the effectiveness of oral contraceptives or depo-progesterone, oral contraceptives or depo-progesterone were not to be used as the sole form of birth control for the duration of this study
- Women of childbearing potential had to have a negative serum human chorionic gonadotropin (b-hCG) within 14 days prior to initiation of study therapy
- Presence of HIV-1 infection as documented by any licensed Enzyme-Linked Immunosorbent Assay (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 at any time prior to study entry
- A CD4+ cell count of 100 cells/mm³ documented within 30 days of baseline visit. If a patient had a history of a clinical AIDS defining event, i.e. Pneumocystis carinii pneumonia (PCP), Kaposi sarcoma, etc, his/her CD4+ cell count had to be >= 200 cells/mm³
Patients could have either a) no prior antiretroviral therapy or b) prior antiretroviral therapy but no Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) therapy. Antiretroviral experienced patients eligible to enroll in this study were patients who had any of the following characteristics
- Switching Patients: Patients with two consecutive ultra-sensitive HIV-RNA assay results below the limit of quantification (BLQ) at least one week apart
- Patients Optimizing Therapy: Patients who had responded with substantial drops in HIV-RNA counts without reaching BLQ or patients who had failed their current regimen and needed to change to a new drug regimen
- Patients Re-starting Therapy: Patients who were antiretroviral experienced but had not received antiretroviral therapy in the previous three months before enrolling in this study All antiretroviral experienced patients had to have been on a stable regimen or for at least three months immediately prior to their enrollment or they had to have been on no antiretroviral therapy for at least three months immediately prior to their enrollment
- Ability and willingness to give written informed consent and comply with study requirements
- Patients must have had an ambulatory performance score of >= 80 on the Karnofsky scale
Exclusion Criteria:
- Female patients who were pregnant or breast-feeding
- Patients with an acute and/or active AIDS defining illness
- History of any illness or drug allergy that in the opinion of the Investigator could confound the results of the study or pose additional risk in administering nevirapine to the patient
- Patients with active invasive infections including pneumonia, septicemia, meningitis and encephalitis; not including upper respiratory infections, dermatologic infection, oral infection and urinary tract infection
- Patients who where currently taking any prescription or non-prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor could interfere with either the absorption, distribution or metabolism of nevirapine or prednisone
The following laboratory parameters documented within 30 days prior to baseline visit:
- Hemoglobin < 9.1 g/dL for men; < 8.9 g/dL for women
- Absolute neutrophil counts < 750 cells/mm³
- Platelet counts < 50000 platelets/mm³
- AST (SGOT)/ALT (SGPT) > five times upper limit of normal range (ULN)
- Creatinine > two times ULN
- Documented or suspected acute hepatitis within 30 days prior to baseline visit irrespective of Aspartate Aminotransferase (AST) Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Alanine Aminotransferase (ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) values that were five times ULN
- Unexplained temperature > 38.5 °C for any seven days or chronic diarrhea defined as more than three stools per day that persisted for 15 days within 30 days prior to baseline visit
- History of illnesses that contraindicated the use of prednisone such as hypertension, diabetes and diseases of the adreno-pituitary axis. Any chronic gastrointestinal conditions that could interfere with study drug absorption
Receipt of the following
- Any NNRTI therapy at anytime prior to baseline visit
- Interferons, interleukins or any vaccine including HIV vaccine within 30 days prior to baseline visit
- Any investigational agents that needed to be continued during the study
- Abacavir
- Patients who would be taking known inhibitors or inducers of P450 metabolic enzymes including ketoconazole, itraconazole, rifampin and phenytoin were not enrolled. In addition the following drugs were not allowed during the study: cytochrome P450 3A4 substrates such a terfenadine, astemizole, cisapride, triazolam and midazolam. Non-nucleoside reverse transcriptase inhibitors other than study-provided nevirapine were not allowed
- The presence of skin rash or mucosal lesions that in the opinion of the Investigator could compromise the wellbeing of the patient or confound that assessment of a nevirapine-associated rash. Localized skin rashes (e.g. facial folliculitis or contact dermatitis) were not to be the only basis for exclusion from this trial
- Presence of occult (microscopic) or frank (macroscopic) blood in the stools
- Any medical condition which in the opinion of the Investigators would interfere with the patient's ability to participate in or adhere to the requirements of this protocol
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Nevirapine + Prednisone
week 1-2: Nevirapine + Prednisone week 3-24: Nevirapine alone |
|
Aktiver Komparator: Nevirapine
week 1-24: Nevirapine
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Incidence of rash
Zeitfenster: up to 42 days after initiation of nevirapine
|
up to 42 days after initiation of nevirapine
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Severity of rash
Zeitfenster: up to 42 days after initiation of nevirapine
|
up to 42 days after initiation of nevirapine
|
Change in Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) count
Zeitfenster: up to 24 weeks
|
up to 24 weeks
|
Number of patients with adverse events
Zeitfenster: up to 198 days
|
up to 198 days
|
Change in Lymphocytes expressing CD4+ Surface Marker (CD4+) count
Zeitfenster: up to 24 weeks
|
up to 24 weeks
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
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
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Reverse-Transkriptase-Inhibitoren
- Inhibitoren der Nukleinsäuresynthese
- Enzym-Inhibitoren
- Anti-HIV-Agenten
- Antiretrovirale Mittel
- Entzündungshemmende Mittel
- Antineoplastische Mittel
- Glukokortikoide
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Antineoplastische Mittel, hormonell
- Cytochrom P-450-Enzyminduktoren
- Cytochrom P-450 CYP3A-Induktoren
- Nevirapin
- Prednison
Andere Studien-ID-Nummern
- 1100.1286
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 .
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