- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00993148
Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 (MIDAS)
26. august 2014 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
San Francisco, California, Forente stater
- Quest Clinical Research
-
-
Florida
-
Miami, Florida, Forente stater
- University of Miami
-
-
Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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Chicago, Illinois, Forente stater, 60612
- CORECenter
-
-
Nebraska
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Omaha, Nebraska, Forente stater
- University of Nebraska
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
Andre navn:
800 mg tab by mouth once daily for 96 weeks
Andre navn:
100 mg capsule by mouth once daily for 96 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Plasma HIV-1 RNA >50
Tidsramme: 24 weeks
|
Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Virologic Failure or Off Study Treatment Regimen
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 24
|
Drug adherence, assessed as number of participants with missed doses over four-day recall
|
Week 24
|
Trough Concentrations (Ctrough) of Maraviroc
Tidsramme: 24 hours
|
Average trough concentration (Ctrough) of maraviroc
|
24 hours
|
Median CD4 Count Change From Baseline
Tidsramme: 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
Tidsramme: 96 weeks
|
Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
|
96 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Babafemi Taiwo, MD, Northwestern University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2010
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. april 2013
Datoer for studieregistrering
Først innsendt
8. oktober 2009
Først innsendt som oppfylte QC-kriteriene
9. oktober 2009
Først lagt ut (Anslag)
12. oktober 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. september 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2014
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdomsattributter
- Infeksjoner
- Smittsomme sykdommer
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Proteasehemmere
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- HIV-proteasehemmere
- Virale proteasehemmere
- HIV-fusjonshemmere
- Virale fusjonsproteinhemmere
- CCR5-reseptorantagonister
- Ritonavir
- Maraviroc
- Darunavir
Andre studie-ID-numre
- MIDAS
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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