Clinical trial NCT01275625: Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: maraviroc
naive
hiv
zidovudine
lamivudine
combivir
Clade A
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2011-01-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
timeFrame: 48 weeks
Secondary outcomes:
measure: Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
measure: Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
measure: Virologic Response: Rate of Virologic Failure at Week 48.
timeFrame: 48 weeks
measure: Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
timeFrame: Week 48
measure: Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
timeFrame: Week 48
measure: Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
timeFrame: Week 48
measure: Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
timeFrame: Week 48
measure: Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.
timeFrame: Week 48
measure: Number of Participants With Genotypic Resistance.
timeFrame: Screening to Week 48 or Time of treatment Failure
measure: Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.
timeFrame: Screening to Week 48 or Time of treatment Failure
Other outcomes:
Locations:
city: Krasnoyarsk
country: Russian Federation
facility: Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
city: Moscow
country: Russian Federation
facility: Federal scientific and methodological center on AIDS prophylaxis and control
city: Moscow
country: Russian Federation
facility: Moscow regional center on AIDS and infectious diseases prophylaxis and control
city: Nizhnij Novgorod
country: Russian Federation
facility: Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Institution Republican clinical infectious hospital of Roszdrav
city: Smolensk
country: Russian Federation
facility: Smolensk Center on AIDS and infectious diseases prophylaxis and control
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lewis ME, Jubb B, Simpson P, Lopatukhin A, Kireev D, Bobkova M, Craig C, van der Ryst E, Westby M, Butler SL. Highly prevalent Russian HIV-1 V3-loop sequence variants are susceptible to maraviroc. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211025156. doi: 10.1177/20402066211025156.