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Completed
NCT03092505
Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA)
Conditions: Herpes Virus-Related Illnesses
Sex: Female
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 190
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: National Institutes of Health Clinical Center Bethesda Maryland
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.
Eligibility Criteria
* INCLUSION CRITERIA:
1. At least 18 years of age
2. Female
3. Weight \>40 kilograms
4. A diagnosis of HIV infection as documented by any positive serological test (ELISA, HIV rapid test, or Western Blot)
5. Participants in Uganda must be eligible for ART by current clinical guidelines in Uganda
6. Willingness to begin ART
7. Will allow storage of biological sample
EXCLUSION CRITERIA:
1. Previous exposure to ART (participants with a brief exposure (\
Source: ClinicalTrials.gov (NCT03092505). StuddyBuddy aggregates publicly available trial information.