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NCT03092505
Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA)
trial in Herpes Virus-Related Illnesses in 190 participants. Completed in 4 February 2021.
1 February 2021
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 190 |
| Start date | 15 June 2018 |
| Primary completion | 1 February 2021 |
| Estimated completion | 4 February 2021 |
| Sites | 2 locations across United States, Uganda |
Conditions studied
- Herpes Virus-Related Illnesses — all drugs for Herpes Virus-Related Illnesses →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 99, female only, with Herpes Virus-Related Illnesses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Herpesviruses Reactivation and Systemic Inflammation Before and After Initiating Antiretroviral Therapy Among Women with HIV in Rakai, Uganda.
Ssempijja V, Callier V, Nason M, Anok A, et al · · 2025 · PMID 41141442 · DOI 10.1093/ofid/ofaf603
Verify or expand the search:
- PubMed search for NCT03092505
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03092505 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03092505.
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