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- Klinische proef NCT01134939
Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Time Perspective:
retro- and prospective
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Aachen, Duitsland
- Boehringer Ingelheim Investigational Site 23
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 10
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 11
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 14
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 19
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 26
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 28
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 33
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 4
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 5
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 8
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Berlin, Duitsland
- Boehringer Ingelheim Investigational Site 9
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Chemnitz, Duitsland
- Boehringer Ingelheim Investigational Site 31
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Dortmund, Duitsland
- Boehringer Ingelheim Investigational Site 29
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Düsseldorf, Duitsland
- Boehringer Ingelheim Investigational Site 27
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Frankfurt, Duitsland
- Boehringer Ingelheim Investigational Site 17
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Frankfurt, Duitsland
- Boehringer Ingelheim Investigational Site 1
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Freiburg, Duitsland
- Boehringer Ingelheim Investigational Site 2
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Giessen, Duitsland
- Boehringer Ingelheim Investigational Site 34
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Hamburg, Duitsland
- Boehringer Ingelheim Investigational Site 22
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Hamburg, Duitsland
- Boehringer Ingelheim Investigational Site 6
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Hannover, Duitsland
- Boehringer Ingelheim Investigational Site 12
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Hannover, Duitsland
- Boehringer Ingelheim Investigational Site 16
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Karlsruhe, Duitsland
- Boehringer Ingelheim Investigational Site 32
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Koblenz, Duitsland
- Boehringer Ingelheim Investigational Site 15
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Köln, Duitsland
- Boehringer Ingelheim Investigational Site 25
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Leipzig, Duitsland
- Boehringer Ingelheim Investigational Site 21
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München, Duitsland
- Boehringer Ingelheim Investigational Site 20
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München, Duitsland
- Boehringer Ingelheim Investigational Site 24
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München, Duitsland
- Boehringer Ingelheim Investigational Site 3
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München, Duitsland
- Boehringer Ingelheim Investigational Site 7
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Münster, Duitsland
- Boehringer Ingelheim Investigational Site 13
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Osnabrück, Duitsland
- Boehringer Ingelheim Investigational Site 18
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Stuttgart, Duitsland
- Boehringer Ingelheim Investigational Site 30
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion criteria:
The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC
Exclusion criteria:
The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
Cohorten en interventies
Groep / Cohort |
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HIV-infected women and men
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Patients With Virologic Response (VR) After 36 Months
Tijdsspanne: 36 months
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VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. |
36 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes in the Viral Load After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months.
Therefore, a negative change represents a decrease in viral load.
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Baseline and 36 months
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Changes in the CD4+ Cell Count After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase in CD4+ cell count.
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Baseline and 36 months
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Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data ( ALT) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (AST) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
Tijdsspanne: Baseline and 36 months
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The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months.
Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .
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Baseline and 36 months
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- 1100.1536
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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Klinische onderzoeken op HIV-infecties
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthWervingHiv | HIV-testen | Hiv-koppeling naar zorg | HIV-behandelingVerenigde Staten
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur du Cameroun en andere medewerkersOnbekendHiv | HIV-niet-geïnfecteerde kinderen | Kinderen blootgesteld aan HIVKameroen
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationVoltooidPartner hiv-testen | HIV-counseling voor koppels | Paar communicatie | HIV-incidentieKameroen, Dominicaanse Republiek, Georgië, Indië
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University of MinnesotaIngetrokkenHIV-infecties | Hiv/aids | Hiv | AIDS | Aids/Hiv probleem | AIDS en infectiesVerenigde Staten
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Erasmus Medical CenterNog niet aan het wervenHIV-infecties | Hiv | HIV-1-infectie | HIV I-infectieNederland
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University of Maryland, BaltimoreIngetrokkenHiv | Niertransplantatie | HIV-reservoir | CCR5Verenigde Staten
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... en andere medewerkersWervingHiv | HIV-testen | Koppeling aan zorgZuid-Afrika
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Hospital Clinic of BarcelonaVoltooidIntegrase-remmers, HIV; HIV PROTEASE INHIBSpanje
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National Taiwan UniversityWerving
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Helios SaludViiV HealthcareOnbekendHiv | HIV-1-infectieArgentinië