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Co-receptor Tropism Determination of HIV-1 Subtype A Spread in the Russian Federation Using V3-based Genotyping Tools (CoTrAST)

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ClinicalTrials.gov Identifier: NCT01823614
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : March 20, 2014
Last Update Posted : March 20, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dmitry Kireev, Central Institute of Epidemiology, Moscow, Russia

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition HIV Infection
Enrollment 943
Recruitment Details Enrollment of patients will be conducted during 4 months of study. Patients will be selected from the AIDS centers and the Republican Clinical Hospital for Infectious Diseases, which are participants of the study. Totally there will be 12 AIDS centers. Expected number of patients will be 70 people per participant.
Pre-assignment Details Patient exclusion criteria: Pregnancy at the time of obtaining of biological material for women, patients receiving cytotoxic agents, patients receiving immunomodulatory drugs, pParticipation in clinical trials with experimental drugs, experience of using of CCR5-antagonists.
Arm/Group Title Naïve Patients, >500 Naïve Patients, 350-500 Naïve Patients, <350 ARVT <6 Months ARVT From 6 Months to 3 Years ARVT >3 Years
Hide Arm/Group Description The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3 The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3 The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3 The group contains patients who have ARVT experience and obtain ART treatment less than 6 months The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
Period Title: Overall Study
Started 179 140 176 122 172 154
Completed 179 140 176 122 172 154
Not Completed 0 0 0 0 0 0
Arm/Group Title Naïve Patients, >500 Naïve Patients, 350-500 Naïve Patients, <350 ARVT <6 Months ARVT From 6 Months to 3 Years ARVT >3 Years Total
Hide Arm/Group Description The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3 The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3 The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3 The group contains patients who have ARVT experience and obtain ART treatment less than 6 months The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years The group contains patients who have ARVT experience and obtain ART treatment more than 3 years Total of all reporting groups
Overall Number of Baseline Participants 179 140 176 122 172 154 943
Hide Baseline Analysis Population Description
The overall number of naive patients should be more than number of treatment-experienced patients.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 179 participants 140 participants 176 participants 122 participants 172 participants 154 participants 943 participants
32
(18 to 60)
33
(18 to 63)
35
(22 to 64)
35
(18 to 65)
36
(21 to 68)
37
(24 to 73)
35
(18 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 179 participants 140 participants 176 participants 122 participants 172 participants 154 participants 943 participants
Female
105
  58.7%
79
  56.4%
96
  54.5%
61
  50.0%
95
  55.2%
73
  47.4%
509
  54.0%
Male
74
  41.3%
61
  43.6%
80
  45.5%
61
  50.0%
77
  44.8%
81
  52.6%
434
  46.0%
Nadir CD4 cell count  
Median (Full Range)
Unit of measure:  Cells/µl
Number Analyzed 179 participants 140 participants 176 participants 122 participants 172 participants 154 participants 943 participants
664
(501 to 1716)
413
(351 to 499)
33
(15 to 349)
288
(5 to 1276)
350
(23 to 2112)
394
(10 to 1201)
380
(5 to 2112)
1.Primary Outcome
Title Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naïve Patients, >500 Naïve Patients, 350-500 Naïve Patients, <350 ARVT <6 Months ARVT From 6 Months to 3 Years ARVT >3 Years
Hide Arm/Group Description:
The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
Overall Number of Participants Analyzed 161 116 159 110 141 126
Measure Type: Number
Unit of Measure: participants
R5-tropic 123 85 114 78 86 82
X4-tropic 38 31 45 32 55 44
2.Secondary Outcome
Title Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD4 Cell Count > 500 CD4 Cell Count 350-500 CD4 Cell Count < 350
Hide Arm/Group Description:
Group which contains patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
Group which contains patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
Group which contains patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
Overall Number of Participants Analyzed 243 216 364
Measure Type: Number
Unit of Measure: participants
R5-tropic 179 160 239
X4-tropic 64 56 125
3.Other Pre-specified Outcome
Title Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD4 Cell Count > 500 CD4 Cell Count 350-500 CD4 Cell Count < 350
Hide Arm/Group Description:
Group which contains naive patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
Group which contains naive patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
Group which contains naive patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
Overall Number of Participants Analyzed 161 116 159
Measure Type: Number
Unit of Measure: participants
R5-tropic 123 85 114
X4-tropic 38 31 45
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naïve Patients, >500 Naïve Patients, 350-500 Naïve Patients, <350 ARVT <6 Months ARVT From 6 Months to 3 Years ARVT >3 Years
Hide Arm/Group Description The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3 The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3 The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3 The group contains patients who have ARVT experience and obtain ART treatment less than 6 months The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
All-Cause Mortality
Naïve Patients, >500 Naïve Patients, 350-500 Naïve Patients, <350 ARVT <6 Months ARVT From 6 Months to 3 Years ARVT >3 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naïve Patients, >500 Naïve Patients, 350-500 Naïve Patients, <350 ARVT <6 Months ARVT From 6 Months to 3 Years ARVT >3 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/179 (0.00%)   0/140 (0.00%)   0/176 (0.00%)   0/122 (0.00%)   0/172 (0.00%)   0/154 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naïve Patients, >500 Naïve Patients, 350-500 Naïve Patients, <350 ARVT <6 Months ARVT From 6 Months to 3 Years ARVT >3 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/179 (0.00%)   0/140 (0.00%)   0/176 (0.00%)   0/122 (0.00%)   0/172 (0.00%)   0/154 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dmitry Kireev
Organization: Central Research Institute for Epidemiology
Phone: +74959749646 ext 2227
Responsible Party: Dmitry Kireev, Central Institute of Epidemiology, Moscow, Russia
ClinicalTrials.gov Identifier: NCT01823614     History of Changes
Other Study ID Numbers: WS2041679
First Submitted: March 30, 2013
First Posted: April 4, 2013
Results First Submitted: February 4, 2014
Results First Posted: March 20, 2014
Last Update Posted: March 20, 2014