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HIV meds may stir up herpes: new study investigates

NCT ID NCT03092505

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 14 times

Summary

This study looked at 190 HIV-positive women starting HIV medicines to see how often herpes virus symptoms appear or get worse. Researchers collected blood, urine, and vaginal samples over a year to track virus activity. The goal was to understand why some women have herpes flare-ups after starting HIV treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

190 people

The number who actually took part.

Started

Jun 2018

Finished

Feb 2021

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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 (\<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) 2. On acyclovir, valacyclovir, valganciclovir, or ganciclovir treatment 3. Pregnancy or intent to become pregnant during the study period 4. Intrauterine device (IUD) use 5. Inability to follow study instructions, according to the investigator's judgment 6. 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 7. Malignancies requiring chemotherapy 8. Therapy with systemic corticosteroids, immunosuppressants or immunomodulating agents 9. Any condition that, in the investigator s opinion, may put the participant at undue risk or compromise the study's scientific objectives

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Conditions

The condition(s) this trial relates to.

Herpesviridae infectious disease HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Herpes virus-related illnesses

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Rakai, Kalisizo, and Villa Maria Hospital

    Kalisizo, Uganda

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