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

NCT01823614 | Completed Results

• 1 other identifier: WS2041679
• Study Type: observational
• Target: 943
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infection

Keywords

HIV infection; tropism determination; genotypic methodic; R5-tropic variant; X4-tropic variant

Outcome Measures

Primary Outcomes (1)

• Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia

  24 weeks

Secondary Outcomes (1)

• Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count

  24 weeks

Other Outcomes (1)

• Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients

  24 weeks

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dmitry Kireev: lead
• Pfizer: collaborator

Study Sites (1)

Central Research Institute for Epidemiology

Moscow, 111123, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma peripheral blood mononuclear cells

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dmitry Kireev
• Organization: Central Research Institute for Epidemiology

dmitry.kireev@pcr.ru

+74959749646

Study Officials

• Dmitry Kireev, PhD

  Central Research Institute for Epidemiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: scientific researcher

Study Record Dates

• First Submitted: March 30, 2013
• First Posted: April 4, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 20, 2014
• Results First Posted: March 20, 2014

Record last verified: 2014-02

Locations

RU (1)