N/A N=943

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

HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT01823614 ↗

Enrolled (actual)

943

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia — 123; 85; 114; 78 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dmitry Kireev
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia	123; 85; 114; 78; 86; 82	—
SECONDARY Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count	179; 160; 239; 64; 56; 125	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01823614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.