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CTN 294: The LAGHDA Study

Longitudinal Analysis of HIV Genetic Diversification under Antiretroviral therapy (LAHGDA)

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About the study (objectives)

The LAGHDA Study is a retrospective pilot study that will measure the genetic evolution of HIV DNA in adults with controlled viral loads and how this evolution is affected by different types of antiretroviral regimens.

About the disease/condition (background/context)

HIV that is successfully and continually suppressed by antiretroviral therapy (ART) can continue to evolve and mutate within viral reservoirs and immune cells throughout the body. Integrase inhibitors are a class of ART drugs that include raltegravir, elvitegravir, dolutegravir, and bictegravir. Integrase inhibitor-based ART regimens are effective at suppressing HIV replication; however, these drugs may also be more effective at preventing the evolution of HIV DNA, compared to other types of treatments. Understanding which treatments are more effective at limiting viral evolution is valuable to clinicians and people living with HIV by helping to inform treatment decisions and importantly, may lead to clues about the mechanisms associated with HIV replication and persistence.

Study Approach (methodology)

This study is retrospective, meaning it will analyze and interpret existing samples from people who previously consented to have their data used for future studies. Historical samples for a 12-month period from three different groups of people will be used: samples from 10 people who were successfully treated with dolutegravir, from 10 who were treated with elvitegravir, and 10 with a non-integrase inhibitor ART. Through DNA sequencing, researchers will compare the extent of the genetic evolution of the viruses collected in each group of people and determine which ART regimen was most effective for this purpose.

Eligibility criteria 

Required:

  • Adult > 18 years old male/female/transgender
  • HIV-positive
  • Successfully treated with first-line antiretroviral therapy for more than 6 months (viral load <50 RNA copies/ml for more than 6 months) with either dolutegravir-, elvitegravir- or non-INSTI-based therapy
  • Taking the same first-line antiretroviral therapy for less than 5 years
  • Blips previous to enrolment are allowed
  • Any background regimen allowed

Not Allowed:

  • Use of raltegravir-based regimens (likely rare since we are seeking participants using first-line therapy; third group is non-INSTI-based regimens)
  • Change in antiretroviral treatment for any personal or medical reason
  • Viral load >500 copies/ml at any visit since HIV replication during blips may contribute to HIV genetic diversification
  • Previous use of antiretroviral treatment other than current one (switch)
  • Resistance against any drug part of current antiretroviral regimen

Participating Sites

McGill University AIDS Centre
Lady Davis Institute for Medical Research Jewish General Hospital
3755 Ch. Côte-Ste-Catherine, Montreal
H3T1E2

Additional Information

If you would like more information on this clinical study, please contact the principal investigator.

Principal Investigator:

Thibault Mesplède, MSc, PhD
Assistant Professor, McGill Department of Microbiology & Immunology
Montreal, Quebec
Email: thibault.mesplede@mcgill.ca

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