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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823614
First Posted: April 4, 2013
Last Update Posted: March 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dmitry Kireev, Central Institute of Epidemiology, Moscow, Russia
Results First Submitted: February 4, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: HIV Infection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Naïve Patients, >500 The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
Naïve Patients, 350-500 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
Naïve Patients, <350 The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
ARVT <6 Months The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
ARVT From 6 Months to 3 Years The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
ARVT >3 Years The group contains patients who have ARVT experience and obtain ART treatment more than 3 years

Participant Flow:   Overall Study
    Naïve Patients, >500   Naïve Patients, 350-500   Naïve Patients, <350   ARVT <6 Months   ARVT From 6 Months to 3 Years   ARVT >3 Years
STARTED   179   140   176   122   172   154 
COMPLETED   179   140   176   122   172   154 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The overall number of naive patients should be more than number of treatment-experienced patients.

Reporting Groups
  Description
Naïve Patients, >500 The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
Naïve Patients, 350-500 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
Naïve Patients, <350 The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
ARVT <6 Months The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
ARVT From 6 Months to 3 Years The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
ARVT >3 Years The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
Total Total of all reporting groups

Baseline Measures
   Naïve Patients, >500   Naïve Patients, 350-500   Naïve Patients, <350   ARVT <6 Months   ARVT From 6 Months to 3 Years   ARVT >3 Years   Total 
Overall Participants Analyzed 
[Units: Participants]
 179   140   176   122   172   154   943 
Age 
[Units: Years]
Mean (Full Range)
 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) 
Gender 
[Units: Participants]
             
Female   105   79   96   61   95   73   509 
Male   74   61   80   61   77   81   434 
Nadir CD4 cell count 
[Units: Cells/µl]
Median (Full Range)
 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) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia   [ Time Frame: 24 weeks ]

2.  Secondary:   Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count   [ Time Frame: 24 weeks ]

3.  Other Pre-specified:   Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: dmitry.kireev@pcr.ru



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