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OpenTrials
Completed

NCT Number: NCT01275625

Combivir And Maraviroc In Antiretroviral Naive Subjects 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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional Center on AIDS and Infectious Diseases Prophylaxis and Control, Krasnoyarsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIV therapy

Drug

Combivir one tablet BD with maraviroc 300mg BD for 48 weeks

Other names: Selzentry, Celsentri

Primary outcomes

  1. Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.

    Time frame: 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.

Secondary outcomes

  1. Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.

    Time frame: 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.

  2. Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.

    Time frame: 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.

  3. Virologic Response: Rate of Virologic Failure at Week 48.

    Time frame: 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.

  4. Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)

    Time frame: Week 48

    Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count

  5. Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)

    Time frame: Week 48

    Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count

  6. Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)

    Time frame: Week 48

    Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.

  7. Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)

    Time frame: Week 48

    Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.

  8. Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.

    Time frame: Week 48

    Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.

  9. Number of Participants With Genotypic Resistance.

    Time frame: 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.

  10. Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 12, 2011
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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