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

NCT03092505 | Completed

• 2 other identifiers: 17007217-I-0072
• Study Type: observational
• Target: 190
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

HSV; Uganda; Sample; Natural History

Outcome Measures

Primary Outcomes (1)

• Compare the prevalence of herpetic disease, demonstrated by viral shedding of HSV-1 and 2 in the vaginal secretions of HIV-positive women prior to and 4 and 8 weeks after ART initiation.

  viral shedding of HSV-1 and 2

  prior to and at 4 and 8 weeks after inititian of antiretroviral treatment

Secondary Outcomes (1)

• 1. To estimate the associations of viral shedding or clinical herpetic disease post-ART at weeks 4 or 8 with concurrent and baseline measurement of systemic inflammation (IL-6, CRP, TNF or sCD14). [ Time Frame: 8 weeks post enrollment ]

  at week 4 and at week 8

Study Arms (1)

Females

Females participants who are about to start first line antiretroviral therapy.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 200 women initiating ART as part of standard HIV care will be recruited at four sites, the NIH Clinical Center (approximately 30-40), the RHSP/ICER , the Villa Maria Hospital and the Kalisizo sites in Uganda (approximately 160-170). Women will be recruited regardless of CD4+ T-cell count, presence of opportunistic infections and co-infection status. Participants taking antibiotics for co-infections and prophylaxis will be able to participate in the study and antibiotic use will be captured in study data. Participants may co-enroll in other non-interventional studies. Pregnant women will be excluded.

You may qualify if:

• At least 18 years of age
• Female
• Weight \>40 kilograms
• A diagnosis of HIV infection as documented by any positive serological test (ELISA, HIV rapid test, or Western Blot)
• Participants in Uganda must be eligible for ART by current clinical guidelines in Uganda
• Willingness to begin ART
• Will allow storage of biological sample

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Rakai, Kalisizo, and Villa Maria Hospital

Kalisizo, Uganda

Location

Related Publications (1)

• Schaftenaar E, Verjans GM, Getu S, McIntyre JA, Struthers HE, Osterhaus AD, Peters RP. High seroprevalence of human herpesviruses in HIV-infected individuals attending primary healthcare facilities in rural South Africa. PLoS One. 2014 Jun 10;9(6):e99243. doi: 10.1371/journal.pone.0099243. eCollection 2014.

  PMID: 24914671 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Steven J Reynolds, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: June 15, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 4, 2021
• Last Updated: June 5, 2026

Record last verified: 2025-08-12

Locations

US (1); UG (1)