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

HIV Disease Clinical Trial

— HSVHIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823779
• Other study ID #: GlobalResearch
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2023
• Source: Global Research Institute
• Contact: Jorge E Rodriguez, M.D.
• Phone: (323) 934-3690
• Email: 2jrodmd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex 1
• Herpes Simplex 2
• HIV Disease

Intervention

Other:
• Blood draw
We will be drawing blood for verify HIV status, HSV 1 or 2 antibodies, CD4 and HIV-PCR

Locations

Country	Name	City	State
United States	Global Research Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Global Research Institute	Rational Vaccines Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiology	The frequency of HSV outbreaks in HIV positive patients.	48 weeks
Secondary	Co Morbidity	Correlation of HSV outbreak with patient CD4 count and/or HIV-PCR	48 weeks