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

• Sponsor: Global Research Institute (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05823779
• Collaborator: Rational Vaccines Inc (Industry)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Disease; Herpes Simplex 1; Herpes Simplex 2	Other: Blood draw

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Apr 1, 2025

Outcome Measures

Primary Outcome Measures

1. Epidemiology [48 weeks]

   The frequency of HSV outbreaks in HIV positive patients.

Secondary Outcome Measures

1. Co Morbidity [48 weeks]

   Correlation of HSV outbreak with patient CD4 count and/or HIV-PCR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Global Research Institute	Los Angeles	California	United States	90036

Sponsors and Collaborators

• Global Research Institute
• Rational Vaccines Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Global Research Institute
• ClinicalTrials.gov Identifier: NCT05823779
• Other Study ID Numbers: GlobalResearch
• First Posted: Apr 21, 2023
• Last Update Posted: Apr 21, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Global Research Institute: HIV, Herpes Simplex 1, Herpes Simplex 2
• Additional relevant MeSH terms: Herpes Simplex

Study Results

No Results Posted as of Apr 21, 2023