NCT05823779

A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Global Research Institute · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is an observational, cohort, prospective study looking at the frequency of Herpes Simplex Virus (HSV) 1 and or 2 outbreaks in HIV positive patients who's HIV virus is controlled on highly active anti-retroviral therapy. We will be enrolling fifty (50) patients.

Detailed description

We will be confirming that the patients are HIV positive and has antibodies to either HSV 1 or HSV 2 as part of the screening process. If so, we will then obtain patient baseline HIV-PCR, CD4, medial history including medications on day one. Whether the patient is on any or no herpes controlling medication. If the patient has what they feel is a flare up of HSV, they will come into clinic where the lesion will be culture and the patient's HIV-PCR and CD4 will also be obtained. Otherwise, the patient will receive phone follow ups every three months to see if there has been and change in their health or medications. The main endpoint is to see if there is a correlation between outbreaks in HIV patients and their CD4 cells and/or HIV and/or Herpes medication.

Conditions

• HIV Disease
• Herpes Simplex 1
• Herpes Simplex 2

Interventions

Type	Name	Description
OTHER	Blood draw	We will be drawing blood for verify HIV status, HSV 1 or 2 antibodies, CD4 and HIV-PCR

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-12-31
• Completion: 2025-04-01
• First posted: 2023-04-21
• Last updated: 2023-04-21

Locations

1 site across 1 country: United States