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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Disease Herpes Simplex 1 Herpes Simplex 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood draw

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

Intervention Type OTHER

Eligibility Criteria

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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.