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Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

13. januar 2014 opdateret af: ViiV Healthcare

A Multicenter, Open Label Study Of Maraviroc, Zidovudine And Lamivudine Twice Daily For The Treatment Of Antiretroviral Naïve HIV-Infected Patients With R5 HIV-1 In Russia

One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

98

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Den Russiske Føderation
      • Krasnoyarsk, Den Russiske Føderation, 660049
        • Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
      • Moscow, Den Russiske Føderation, 105275
        • Federal scientific and methodological center on AIDS prophylaxis and control
      • Moscow, Den Russiske Føderation, 129110
        • Moscow regional center on AIDS and infectious diseases prophylaxis and control
      • Nizhnij Novgorod, Den Russiske Føderation, 603005
        • Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
      • Saint-Petersburg, Den Russiske Føderation, 190103
        • Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
      • Saint-Petersburg, Den Russiske Føderation, 196645
        • Federal State Institution Republican clinical infectious hospital of Roszdrav
      • Smolensk, Den Russiske Føderation, 214006
        • Smolensk Center on AIDS and infectious diseases prophylaxis and control
      • Volgograd, Den Russiske Føderation, 400040
        • Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Over 18 years of age.
  • R5 HIV infection on screening tropism test.
  • Viral load >1,000 copies/mL.
  • Never previously treated with anti-HIV medicines.

Exclusion Criteria:

  • Previously treated with anti-HIV medicines.
  • Hepatitis B co-infection.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment
Single arm study of combivir and maraviroc for 48 weeks
Medicin: HIV therapy
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Andre navne:
  • Selzentry, Celsentri

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
Tidsramme: 48 weeks
Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
48 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Tidsramme: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Tidsramme: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Virologic Response: Rate of Virologic Failure at Week 48.
Tidsramme: 48 weeks
Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.
48 weeks
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Tidsramme: Week 48
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count
Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Tidsramme: Week 48
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count
Week 48
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Tidsramme: Week 48
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.
Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Tidsramme: Week 48
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.
Week 48
Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.
Tidsramme: Week 48
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
Week 48
Number of Participants With Genotypic Resistance.
Tidsramme: Screening to Week 48 or Time of treatment Failure
The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.
Screening to Week 48 or Time of treatment Failure
Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.
Tidsramme: Screening to Week 48 or Time of treatment Failure
Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).
Screening to Week 48 or Time of treatment Failure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ViiV Healthcare

Samarbejdspartnere

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2011

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

11. januar 2011

Først indsendt, der opfyldte QC-kriterier

11. januar 2011

Først opslået (Skøn)

12. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A4001101

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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