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

Recruiting

• Conditions: HIV Disease; Herpes Simplex 1; Herpes Simplex 2

• Registration Number: NCT05823779
• Lead Sponsor: Global Research Institute

Brief 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.

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-04-09
• Last Update Submitted: 2023-04-09
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2024-12-31
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Subject must be 18 years or older at the time of screening
2. Males, Females, Transgender Male and Transgender Females
3. HIV positive
4. Positive antibody to HSV- 1/and or HSV-2
5. If Female of child baring potential, documented negative pregnancy test at the time of screening.

Exclusion Criteria

1. Active opportunistic infection
2. Current chemotherapy
3. Unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiology	48 weeks	The frequency of HSV outbreaks in HIV positive patients.

Secondary Outcome Measures

Name	Time	Method
Co Morbidity	48 weeks	Correlation of HSV outbreak with patient CD4 count and/or HIV-PCR

Trial Locations

Locations (1)

Global Research Institute; 🇺🇸 Los Angeles, California, United States