Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
13. januar 2014 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
98
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Krasnoyarsk, Den russiske føderasjonen, 660049
- Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Moscow, Den russiske føderasjonen, 105275
- Federal scientific and methodological center on AIDS prophylaxis and control
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Moscow, Den russiske føderasjonen, 129110
- Moscow regional center on AIDS and infectious diseases prophylaxis and control
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Nizhnij Novgorod, Den russiske føderasjonen, 603005
- Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Saint-Petersburg, Den russiske føderasjonen, 190103
- Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
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Saint-Petersburg, Den russiske føderasjonen, 196645
- Federal State Institution Republican clinical infectious hospital of Roszdrav
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Smolensk, Den russiske føderasjonen, 214006
- Smolensk Center on AIDS and infectious diseases prophylaxis and control
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Volgograd, Den russiske føderasjonen, 400040
- Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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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:
- 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Treatment
Single arm study of combivir and maraviroc for 48 weeks
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Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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48 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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.
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Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
|
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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
|
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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.
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48 weeks
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Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Tidsramme: Week 48
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Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count
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Week 48
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Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Tidsramme: Week 48
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Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count
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Week 48
|
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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.
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Week 48
|
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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
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Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.
Tidsramme: Week 48
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Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
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Week 48
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Number of Participants With Genotypic Resistance.
Tidsramme: Screening to Week 48 or Time of treatment Failure
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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.
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Screening to Week 48 or Time of treatment Failure
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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
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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).
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Screening to Week 48 or Time of treatment Failure
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
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Hjelpsomme linker
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. juni 2011
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
11. januar 2011
Først innsendt som oppfylte QC-kriteriene
11. januar 2011
Først lagt ut (Anslag)
12. januar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. januar 2014
Sist bekreftet
1. januar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A4001101
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