Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
13 januari 2014 uppdaterad 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
98
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Krasnoyarsk, Ryska Federationen, 660049
- Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Moscow, Ryska Federationen, 105275
- Federal scientific and methodological center on AIDS prophylaxis and control
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Moscow, Ryska Federationen, 129110
- Moscow regional center on AIDS and infectious diseases prophylaxis and control
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Nizhnij Novgorod, Ryska Federationen, 603005
- Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Saint-Petersburg, Ryska Federationen, 190103
- Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
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Saint-Petersburg, Ryska Federationen, 196645
- Federal State Institution Republican clinical infectious hospital of Roszdrav
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Smolensk, Ryska Federationen, 214006
- Smolensk Center on AIDS and infectious diseases prophylaxis and control
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Volgograd, Ryska Federationen, 400040
- Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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-
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:
- 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
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: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Treatment
Single arm study of combivir and maraviroc for 48 weeks
|
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Tidsram: 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.
|
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.
Tidsram: 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.
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Week 48
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Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.
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Week 48
|
|
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
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Användbara länkar
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 juni 2011
Primärt slutförande (Faktisk)
1 oktober 2012
Avslutad studie (Faktisk)
1 juli 2013
Studieregistreringsdatum
Först inskickad
11 januari 2011
Först inskickad som uppfyllde QC-kriterierna
11 januari 2011
Första postat (Uppskatta)
12 januari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
3 mars 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 januari 2014
Senast verifierad
1 januari 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A4001101
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 .