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

Completed

Conditions studied: Herpes Virus-Related Illnesses

In brief

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. ...

Key facts

Study ID

NCT03092505

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

190

Starts

2018-06-15

Expected to finish

2021-02-04

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Previous exposure to ART (participants with a brief exposure (<3 months) that occurred greater thatn or equal to 6 months prior to screening will be eligible to enroll if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol)
• On acyclovir, valacyclovir, valganciclovir, or ganciclovir treatment
• Pregnancy or intent to become pregnant during the study period
• Intrauterine device (IUD) use
• Inability to follow study instructions, according to the investigator's judgment
• Active, serious infections other than HIV infection that may interfere with study participation (eg, severe cerebral toxoplasmosis or cryptococcal meningitis) during the 2 weeks prior to enrollment
• Malignancies requiring chemotherapy
• Therapy with systemic corticosteroids, immunosuppressants or immunomodulating agents
• Any condition that, in the investigator s opinion, may put the participant at undue risk or compromise the study's scientific objectives

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• Rakai, Kalisizo, and Villa Maria Hospital — Kalisizo, Uganda

Full record on ClinicalTrials.gov

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