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CTNPT 016: Herpesvirus shedding among HIV inpatients

Assessing feasibility of collecting repeated blood and swab samples for herpesviruses in HIV-infected individuals hospitalized with acute illness

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About the study

This study will enroll people living with HIV who have been admitted to hospital with an acute illness or opportunistic infection and study whether common viruses like herpes simplex virus type 2 (HSV-2) and cytomegalovirus (CMV) could contribute to their hospital outcomes even without causing symptoms. Between 55 to 85 per cent of people living with HIV in Canada are infected with these viruses. Study researchers will quantify the shedding of herpes viruses in distinct anatomic sites (oral mucosa, genital mucosa, anal mucosa, blood), and compare the association between the shedding of virus with length of stay in the hospital.

The primary objective of this pilot study is to determine the feasibility of running a larger clinical study on this research question, and ultimately a trial of valacyclovir or valganciclovir for this population. Both are antiviral drugs that slow the growth and spread of herpes viruses. The researchers will accomplish this by measuring the feasibility of collecting repeated blood and mucosal samples from participants and comparing the amount of virus shedding to the total length of stay in the hospital. In total, study researchers are looking to approach 80 people for the study.

About the Condition

Co-infection with herpes viruses such as herpes simplex virus type 2 (HSV-2) and cytomegalovirus (CMV) is common for adults living with HIV. These viruses can cause lifelong illness with periodic reactivation and may contribute to poor health outcomes. The reactivation or outbreak of the virus can occur in the respiratory tract, the blood, and many other tissues and has been linked to increased health risks. As such, HIV patients hospitalized with opportunistic infections and illnesses represent a subgroup at particular risk for adverse short-term health outcomes.

Study Approach

Potential participants will first be approached and asked whether they consent to specimen collection. Patients that consent will undergo repeated collection of blood and mucosal specimens for HSV/ CMV testing.

Eligibility criteria

Individuals will be eligible for the study if they meet the following inclusion criteria:

Inclusion Criteria

  • Adult aged 18 years or older
  • Documented HIV-1 infection
  • Admitted to an acute care hospital for confirmed or suspected acute opportunistic infection or other acute illness

Exclusion Criteria

  • Use of systemic medication with anti-HSV or CMV activity at time of admission (i.e., acyclovir, valacyclovir, famciclovir, ganciclovir, valganciclovir, cidofovir, foscarnet)
  • Clinical indication for any systemic medication with anti-HSV or CMV activity during hospital stay
  • Any manifestation of HSV or CMV as reason for hospital admission
  • Inability to communicate fluently with study personnel due to language or other communication barriers

Sites

Ontario

Dr. Darrell Tan
St. Michael’s Hospital, Toronto
Ph: 416-864-5568

Additional Information

If you would like more information on this clinical study, please refer to a participating site.

Principal Investigator

Dr. Darrell Tan
St. Michael’s Hospital, Toronto
Ph: 416-864-5568

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