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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05823779

Acronym

HSVHIV

Enrollment

Registered

2023-04-21

Start date

2022-04-01

Completion date

2025-04-01

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex 1, Herpes Simplex 2, HIV Disease

Keywords

HIV, Herpes Simplex 1, Herpes Simplex 2

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.

Interventions

OTHERBlood draw

We will be drawing blood for verify HIV status, HSV 1 or 2 antibodies, CD4 and HIV-PCR

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

Primary ContactJorge E Rodriguez, M.D.

2jrodmd@gmail.com(323) 934-3690

Backup ContactMichael S Gottlieb, M.D.

drmichael.gottlieb@gmail.com(323) 215-1725

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026