- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00993148
Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 (MIDAS)
26 augusti 2014 uppdaterad av: Babafemi Taiwo, Northwestern University
Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile
The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1.
The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
25
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna
- Quest Clinical Research
-
-
Florida
-
Miami, Florida, Förenta staterna
- University of Miami
-
-
Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Chicago, Illinois, Förenta staterna, 60612
- CORECenter
-
-
Nebraska
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Omaha, Nebraska, Förenta staterna
- University of Nebraska
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry
- Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtained within 90 days prior to study entry
- Exclusive R5 tropism based on enhanced sensitivity Trofile assay done within 90 days prior to entry
- CD4 cell count > 100 cells/mm3 within 90 days prior to study entry
- HIV genotype (for RT and protease) performed at any time before study entry (Subjects with single or combination NNRTI or NRTI RAM(s) at screening are permitted)
- ARV drug-naïve, defined as no previous ARV treatment at any time prior to study entry
- Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
- Negative result from a hepatitis C antibody test performed within 90 days prior to study entry
Laboratory values obtained within 30 days prior to study entry:
- ANC >=750/mm3
- Hemoglobin >=10 g/dL
- Platelets >=50,000/mm3
- AST (SGOT), ALT (SGPT), and alkaline phosphatase <=5 x ULN
- Calculated creatinine clearance (CrCl) >=30 mL/min, as estimated by the Cockcroft-Gault equation*
- Negative serum or urine pregnancy test within 48 hours prior to study entry for women with reproductive potential
- If participating in sexual activity that could lead to pregnancy, the study subjects with reproductive potential must use one form of contraceptive while receiving protocol-specified medications and for 60 days after stopping the medications.
- Men and women age >=18 years
- Ability and willingness of subject or legal guardian/representative to provide informed consent
Exclusion Criteria:
- Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry
- Screening HIV genotype obtained any time prior to study entry with any DRV RAM (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)
- Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy. NOTE: Subjects receiving stable physiologic glucocorticoid doses (defined as prednisone ≤10 mg/day [or equivalent] as a stable or tapering dose) are permitted. Subjects receiving corticosteroids for acute therapy for PCP or asthma exacerbation, or receiving a short course (defined as ≤2 weeks of pharmacologic glucocorticoid therapy) are permitted
- Breast-feeding
- Requirement for any medication that is prohibited with a study medication
- Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion
- Active drug or alcohol use or dependence that could interfere with adherence to study requirements
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Maraviroc plus darunavir/ritonavir
Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
|
150 mg tab by mouth once daily for 96 weeks
Andra namn:
800 mg tab by mouth once daily for 96 weeks
Andra namn:
100 mg capsule by mouth once daily for 96 weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants With Plasma HIV-1 RNA >50
Tidsram: 24 weeks
|
Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL
|
24 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants With Virologic Failure or Off Study Treatment Regimen
Tidsram: 24 weeks
|
Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)
|
24 weeks
|
Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL
Tidsram: 48 weeks
|
Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
|
48 weeks
|
Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher
Tidsram: 96 weeks
|
Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen
|
96 weeks
|
Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES
Tidsram: At study entry and at the time of virologic failure
|
At study entry and at the time of virologic failure
|
|
Drug Adherence, Number of Participants With Missed Doses
Tidsram: Week 24
|
Drug adherence, assessed as number of participants with missed doses over four-day recall
|
Week 24
|
Trough Concentrations (Ctrough) of Maraviroc
Tidsram: 24 hours
|
Average trough concentration (Ctrough) of maraviroc
|
24 hours
|
Median CD4 Count Change From Baseline
Tidsram: 96 weeks
|
Median changes from baseline in peripheral CD4+ T-cell count
|
96 weeks
|
Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL
Tidsram: 96 weeks
|
Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
|
96 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Babafemi Taiwo, MD, Northwestern University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2010
Primärt slutförande (Faktisk)
1 april 2013
Avslutad studie (Faktisk)
1 april 2013
Studieregistreringsdatum
Först inskickad
8 oktober 2009
Först inskickad som uppfyllde QC-kriterierna
9 oktober 2009
Första postat (Uppskatta)
12 oktober 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2014
Senast verifierad
1 augusti 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Sjukdomsegenskaper
- Infektioner
- Smittsamma sjukdomar
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Proteashämmare
- Cytokrom P-450 CYP3A-hämmare
- Cytokrom P-450 enzymhämmare
- HIV-proteashämmare
- Virala proteashämmare
- HIV-fusionshämmare
- Virala fusionsproteinhämmare
- CCR5-receptorantagonister
- Ritonavir
- Maraviroc
- Darunavir
Andra studie-ID-nummer
- MIDAS
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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