HIV drug comparison study seeks clues to shrink hidden virus
NCT ID NCT05584397
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 40 people with HIV to see if a common drug, tenofovir, causes more immune system activation and helps the virus hide better in the body. Participants are already on stable HIV treatment and will provide blood and gut samples. The goal is to find ways to reduce the hidden HIV reservoir and improve long-term health.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
People living with HIV (PWH) on stable use of antiretroviral therapy (ART). They will be between 18 and 65 years of age. Children less than 18 years of age are excluded. Women of childbearing potential should not be pregnant to participate.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Confirmed HIV infection, by two different positive antibody tests and/or detectable plasma HIV RNA on two different dates 2. ≥18 and ≤65 years of age 3. Stable use of ART medication for ≥ 1 year 4. No switch of ART regimen within the past 180 days 5. CD4 \> 350/mm3 within the past 180 days 6. HIV RNA \<40 copies / mL on ≥ 2 occasions during continuous ART of ≥ 1 years, with no blip of \>1000 HIV RNA copies / mL 7. Karnofsky score ≥80 8. Willingness and ability to provide informed consent for study participation 9. Willingness to undergo all required study procedures Exclusion Criteria: 1. Active malignancy including myelodysplastic syndrome, or myeloproliferative disease within 24 weeks prior to study entry 2. Prior organ or bone marrow transplantation 3. Diagnosed autoimmune disease 4. Medical need for ongoing treatment with an immunosuppressive drug 5. Diagnosis of AIDS (defined as any AIDS-defining opportunistic infection or cancer, or a history of blood CD4+ T cell count \< 200/μL) 6. Active opportunistic infection 7. Vomiting or diarrhea which prohibits consistent use of ART 8. Pregnant or breastfeeding 9. Excessive ingestion of ethanol determined by an AUDIT score of \>8 10. Substance abuse 11. History of medical non-compliance 12. The following laboratory values (\< 30 days before enrollment): * Hemoglobin \< 8.5 mg/dL * Platelet count \< 100,000/μL * Coagulation (PT/PTT) tests above the normal reference * Creatinine clearance \< 60 mL/min 13. Using disallowed medications: * Systemic corticosteroids * Other immunosuppressive medications (e.g., cyclosporine, sirolimus, tacrolimus, pimecrolimus, tofacitinib) 14. BMI \> 40 15. Pulmonary dysfunction. 16. Use of narcotics.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Washington Positive Research and the Gastroenterology Clinic at Harborview Medical Center
Seattle, Washington, 98104, United States
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