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

NCT05823779 | Unknown

• 1 other identifier: GlobalResearch
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Disease; Herpes Simplex 1; Herpes Simplex 2

Keywords

HIV, Herpes Simplex 1, Herpes Simplex 2

Outcome Measures

Primary Outcomes (1)

• Epidemiology

  The frequency of HSV outbreaks in HIV positive patients.

  48 weeks

Secondary Outcomes (1)

• Co Morbidity

  48 weeks

Interventions

Blood draw OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subject must be 18 years or older at the time of screening
• Males, Females, Transgender Male and Transgender Females
• HIV positive
• Positive antibody to HSV- 1/and or HSV-2
• If Female of child baring potential, documented negative pregnancy test at the time of screening.

You may not qualify if:

• Active opportunistic infection
• Current chemotherapy
• Unable to give informed consent

Sponsors & Collaborators

• Global Research Institute: lead
• Rational Vaccines Inc: collaborator

Study Sites (1)

Global Research Institute

Los Angeles, California, 90036, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We are retaining patient serum

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jorge E Rodriguez, M.D.

CONTACT

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

Michael S Gottlieb, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 21, 2023
• Study Start: April 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: April 1, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At conclusion of the study
• Access Criteria: Total Access

Locations

US (1)