A5351s: Immune-modularity drugs and CMV replication

Effect of Immune-Modulatory Interventions on Cytomegalovirus Replication during Suppressive Antiretroviral Therapy

Study Description
Cytomegalovirus (CMV) is a relatively common kind of herpes virus that is usually harmless but is capable of producing severe problems for individuals with compromised immune systems, such as people who are HIV-1 infected.  Recent studies suggest that even when no symptoms are present, when CMV replicates (makes more copies of itself), it could contribute to the inflammation in the body.

This observational substudy is designed to evaluate the effects of immune-modulatory treatment (drugs designed to reduce inflammation in blood) on CMV replication in the genital tract and mouth. 

Why is this study being done?
The purpose of this substudy is to measure whether drugs designed to reduce inflammation in blood might also have an effect on the amount of CMV in the genital tract and in the mouth.  

Who can join?
Participation in this substudy is limited to individuals participating in another, ie. “parent”,  ACTG study of an immune-modulatory treatment who are:

  • Willing to donate genital secretions and oral swabs
  • Willing to refrain from sexual activity for at least 48 hours prior to each study visit.

What do I need to do in the study?
Genital secretions, oral swabs and urine will be collected in addition to blood collected at parent study visits.    

What treatments or drugs are involved with this study?
Treatment as defined by the parent study. 

 

Study Status: