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NCT03092505 · ClinicalTrials.gov registry record
Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA)
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 190
- Enrollment target
NCT03092505: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03092505 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 190 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03092505 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 190 participants
- Enrollment target
Study Summary
Background: Herpes virus can cause sores on the body. It can cause flu-like symptoms like fever and muscle aches, and even a type of cancer. Many people with HIV also have infections with herpes virus. When these people start taking HIV medicines, their herpes virus symptoms can suddenly start or become worse. Researchers want to find out more about how often this happens and why. Objective: To study the effects of HIV treatment in women who may have herpes virus infections. Eligibility: Women age 18 years and older who have been diagnosed with HIV infection. Design: Participants will be screened with a physical exam, medical history, and blood and urine tests. Participants will have about 8 study visits. Each will take about 1-2 hours. Participants will return to the clinic 1-2 weeks after the screening visit to receive their antiretroviral (ART) medicine. They will get instructions for taking it. Participants will have 6 more study visits over 1 year. During study visits, participants will have blood and urine tests, vaginal fluid collected, and an oral swab. They may have an external genital exam. They will get their next supply of ART medicine. Some participants may have a chest x-ray. Participants may have leukapheresis. Blood will be removed through a needle in an arm. It will be run through a machine that separates out the white blood cells. The rest of the blood will be returned through a needle in the other arm. The total time participants will be in the study is about 1 year. ...
Primary Outcome
viral shedding of HSV-1 and 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2021-02-04 |
What the finished NCT03092505 record still lists
NCT03092505 is an observational study that tracks outcomes without assigning an intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03092505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03092505 about?
NCT03092505 is a clinical study titled "Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA)". Background: Herpes virus can cause sores on the body. It can cause flu-like symptoms like fever and muscle aches, and even a type of cancer. Many people with HIV also have infections with herpes virus. When these people start taking HIV medicines, their herpes virus symptoms can suddenly start or b...
What is the current status of trial NCT03092505?
This trial is currently completed. The enrollment target is 190 participants. The study started on 2018-06-15. Estimated completion is 2021-02-04.
Who is sponsoring clinical trial NCT03092505?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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