The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH

ConditionsHiv AIDS CD4 Deficiency ART Treatment Resistant Disorders Treatment-Sensitive HIV Infection

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-100

SponsorMedical University of Warsaw

About this trial

Since the reasons for differential immune reconstitution in HIV-infected patients are still not fully understood, we considered it reasonable to investigate whether the presence of primary HIV drug resistance mutations could be one of the factors of inadequate immune reconstitution.

Evaluation of unfavorable factors of immune reconstitution can help identify patients at risk of persistently low CD4 cell counts and CD4:CD8 ratios and requiring careful monitoring for progression to AIDS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV-1 confirmed infection

ART naive patients > 18 years

virological suppression after 6 months of ART

available results of HIV genotyping before the start of ART

Disqualifiers

hematologic neoplasms

use of chemotherapy, immunosuppressive drugs and other myelotoxic agents

lack of patient's consent to participate in the study

Trial population

Patients who will meet the inclusion and not the exclusion criteria will be divided into the 2 groups: with and without DRMs, depending on the results of HIV genotyping. In cohorts subsequent CD4 count and CD4/CD8 ratio will be assessed every 6-12 months in the 4 -year period. Differences in the increase in CD4+ lymphocyte count and CD4:CD8 ratio between patients with primary drug resistance mutations and those without these mutations were taken as the endpoint.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

differences in CD4 reconstruction
Other intervention
Differences in the increase in CD4 lymphocyte count and CD4:CD8 ratio between patients with primary drug resistance mutations and those without these mutations.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: DRM negative1 intervention

Group B: DRM positive1 intervention

Trial outcomes

Primary outcomes

Differences in CD4 recovery regarding the presence of HIV DRM

Differences in the increase in CD4+ lymphocyte (cells/µL) count and CD4:CD8 ratio between patients with primary drug resistance mutations and those without these mutations were taken as the endpoint.

Time frame

4 years

Locations

This trial has no locations.

Sponsors and contacts

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Medical University of Warsaw

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: