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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:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dmitry Kireev, Central Institute of Epidemiology, Moscow, Russia
ClinicalTrials.gov Identifier:
NCT01823614
First received: March 30, 2013
Last updated: February 4, 2014
Last verified: February 2014
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dmitry Kireev, scientific researcher, Central Institute of Epidemiology, Moscow, Russia
ClinicalTrials.gov Identifier: NCT01823614     History of Changes
Other Study ID Numbers: WS2041679
Study First Received: March 30, 2013
Results First Received: February 4, 2014
Last Updated: February 4, 2014
Health Authority: Russia: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 19, 2014