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

April 9, 2023 updated by: Global Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jorge E Rodriguez, M.D.
  • Phone Number: 4 (323) 934-3690
  • Email: 2jrodmd@gmail.com

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90036
        • Recruiting
        • Global Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge E Rodriguez, MD
        • Sub-Investigator:
          • Michael S. Gottlieb, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who are positive for HIV antibodies and IgG or IgM antibodies to Herpes Simplex Virus 1 or Herpes Simplex Virus 2

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiology
Time Frame: 48 weeks
The frequency of HSV outbreaks in HIV positive patients.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co Morbidity
Time Frame: 48 weeks
Correlation of HSV outbreak with patient CD4 count and/or HIV-PCR
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Research Institute

Collaborators

Rational Vaccines Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

April 9, 2023

First Submitted That Met QC Criteria

April 9, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlobalResearch

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share with Rational Vaccine

IPD Sharing Time Frame

At conclusion of the study

IPD Sharing Access Criteria

Total Access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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