HIV DiseaseHSVHIVNCT05823779
A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects
An observational study of HIV Disease and Herpes Simplex 1, run by Global Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Disease, Herpes Simplex 1, Herpes Simplex 2
- What is being tested?
- Blood draw
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are positive for HIV antibodies and IgG or IgM antibodies to Herpes Simplex Virus 1 or Herpes Simplex Virus 2
Who may be able to join
- 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.
Who cannot join
- Active opportunistic infection
- Current chemotherapy
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Global Research Institute
Los Angeles, California, 90036
Jorge E Rodrigiuez, MD, 323-934-3690 ext. 4, 2jrodmd@gmail.com
Michael S Gottlieb, M.D., (323) 215-1725, drmichael.gottlieb@gmail.com
About this study
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.
Read the 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.
- Conditions
- HIV Disease, Herpes Simplex 1, Herpes Simplex 2
- Being tested
- Blood draw
- Keywords
- HIV, Herpes Simplex 1, Herpes Simplex 2
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
We will be drawing blood for verify HIV status, HSV 1 or 2 antibodies, CD4 and HIV-PCR
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology
The frequency of HSV outbreaks in HIV positive patients.
Measured: 48 weeks
Secondary outcomes (1)
Co Morbidity
Correlation of HSV outbreak with patient CD4 count and/or HIV-PCR
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rational Vaccines Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823779
- Sponsor's protocol ID
- GlobalResearch
- Acronym
- HSVHIV
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share with Rational Vaccine
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects
- ClinicalTrials.gov ID
- NCT05823779
- Acronym / sponsor ID
- HSVHIV / GlobalResearch
- Conditions
- HIV Disease, Herpes Simplex 1, Herpes Simplex 2
- Keywords
- HIV, Herpes Simplex 1, Herpes Simplex 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Global Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Rational Vaccines Inc
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are positive for HIV antibodies and IgG or IgM antibodies to Herpes Simplex Virus 1 or Herpes Simplex Virus 2
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Active opportunistic infection
- Current chemotherapy
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawWe will be drawing blood for verify HIV status, HSV 1 or 2 antibodies, CD4 and HIV-PCR | Other | – |
Primary outcome
Epidemiology
Time frame: 48 weeks
The frequency of HSV outbreaks in HIV positive patients.
1 secondary outcome
Co Morbidity
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Yes. Share with Rational Vaccine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Disease and Herpes Simplex 1, run by Global Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge E Rodriguez, M.D. ((323) 934-3690 ext. 4, 2jrodmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.