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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
  Purpose

To date, all work related to the study of HIV tropism, was performed on HIV B and C subtypes. In the studied samples, HIV variants of subtype A were virtually absent. However, the existence has been shown previously of some differences in the nucleotide sequences in the V3 loop of env region of subtype A from other subtypes of virus. In the Russian Federation the subtype A of HIV-1 is predominant, and, according to some estimates, accounts for about 89% of all newly diagnosed cases of HIV infection. Thus, it seems interesting and effective to study the characteristics of HIV-1 subtype A, associated with the tropism, in the Russian Federation.

The primary objective is determination of the prevalence of R5 (chemokine receptor 5), X4 (chemokine receptor 4), and R5X4-tropic variants of HIV in HIV-infected population in Russia, and analysis of the possible features of tropism of viruses belonging to subtype A.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epidemiological Study of the Co-receptor Tropism of HIV-1 Subtype A Spread in the Russian Federation Among naïve and ART-experienced Patients Using V3-based Genotyping Tools

Resource links provided by NLM:


Further study details as provided by Dmitry Kireev, Central Institute of Epidemiology, Moscow, Russia:

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

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

Other Outcome Measures:
  • Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients [ Time Frame: 24 weeks ]

Biospecimen Retention:   Samples With DNA
plasma peripheral blood mononuclear cells

Enrollment: 943
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • Patients with confirmed HIV infection
  • Confirmation of informed consent provided in writing
  • Russian Federation citizenship
  • Age 18 years and older
  • Absence of pregnancy at the time of obtaining of biological material
  • Availability of data about the date of 1st positive immune blot test, date of diagnosis and formulation of the clinical diagnosis, the result of viral load analysis performed in the previous 3 months, measuring of CD4 cell count performed in the previous 3 months, information about the ongoing ARV therapy for patients receiving antiretroviral therapy

Exclusion Criteria:

  • Pregnancy at the time of obtaining of biological material
  • Patients receiving cytotoxic agents due to chemotherapy of cancer
  • Patients receiving immunomodulatory drugs
  • Participation in clinical trials with experimental drugs
  • Experience of using of CCR5-antagonists
  • Any condition which in the opinion of the investigator may affect the evaluation of the study results
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823614


Locations
Russian Federation
Central Research Institute for Epidemiology
Moscow, Russian Federation, 111123
Sponsors and Collaborators
Dmitry Kireev
Pfizer
Investigators
Principal Investigator: Dmitry Kireev, PhD Central Research Institute for Epidemiology
  More Information

Responsible Party: Dmitry Kireev, scientific researcher, 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
Last Verified: February 2014

Keywords provided by Dmitry Kireev, Central Institute of Epidemiology, Moscow, Russia:
HIV infection
tropism determination
genotypic methodic
R5-tropic variant
X4-tropic variant

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases