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Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA)

NCT03092505 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2026-04-24

No results posted yet for this 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.

Conditions

  • Herpes Virus-Related Illnesses

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Steven J Reynolds, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2021-02-01
Completion
2021-02-04

Countries

  • United States
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092505 on ClinicalTrials.gov