NCT05584397Enrolling by invitation
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV (PWH) on Tenofovir-containing Versus NRTI-sparing ART
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
The goal of the project is to determine the difference in immune activation and HIV reservoir size between People living with HIV (PWH) on tenofovir-containing antiretroviral therapy (ART) versus PWH on nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART. Tenofovir (TFV), a phosphonated nucleoside reverse transcriptase inhibitor (NRTI), is being used for oral pre-exposure prophylaxis (PrEP). The investigators will test this hypothesis: tenofovir, and perhaps NRTIs in general, stimulate a type I/III interferon also in PWH who take these drugs. Because chronic interferon stimulation may promote the survival and proliferation of cells with integrated provirus, the investigators also hypothesize that these drugs antagonize decay of the HIV latent reservoir in PWH on ART. Consequently, the researchers hypothesize that PWH who have switched from NRTI-containing ART to NRTI-sparing ART exhibit lower type I/III interferon pathway activation and lower latent HIV reservoir size. The investigators also hypothesize that independently of treatment, the extent of type I/III interferon activation correlates with latent HIV reservoir size. Thus, the proposed study seeks to answer these two questions. Can the gastrointestinal epithelium be impacted by ART, and contribute to chronic immune activation and expansion of the HIV-1 reservoir? If so, what therapeutic approaches can the investigators implement to reduce the HIV-1 proviral load? The data will reveal pathways that can be targeted therapeutically to treat chronic immune activation in PWH. The findings of this study will immediately translate to optimize the standard of care in PWH.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 5 Oct 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- University of Washington
- Diseases
- HIV
- NCT number
- NCT05584397
What you commit to
- Study type: Observational
- Planned participants: 40
- From 1 Sept 2022 to the primary completion date, 30 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active malignancy including myelodysplastic syndrome, or myeloproliferative disease within 24 weeks prior to study entry
- Prior organ or bone marrow transplantation
- Medical need for ongoing treatment with an immunosuppressive drug
- Using disallowed medications:
- Systemic corticosteroids
- Other immunosuppressive medications (e.g., cyclosporine, sirolimus, tacrolimus, pimecrolimus, tofacitinib)
Other illness
- Diagnosed autoimmune disease
- Active opportunistic infection
- History of medical non-compliance
Lab values
- Diagnosis of AIDS (defined as any AIDS-defining opportunistic infection or cancer, or a history of blood CD4+ T cell count \< 200/μL)
- 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
Other
- Vomiting or diarrhea which prohibits consistent use of ART
- Pregnant or breastfeeding
- Excessive ingestion of ethanol determined by an AUDIT score of \>8
- Substance abuse
- BMI \> 40
- Pulmonary dysfunction.
- Use of narcotics.
Who the study is looking for
- Confirmed HIV infection, by two different positive antibody tests and/or detectable plasma HIV RNA on two different dates
- ≥18 and ≤65 years of age
- Stable use of ART medication for ≥ 1 year
- No switch of ART regimen within the past 180 days
- CD4 \> 350/mm3 within the past 180 days
- HIV RNA \<40 copies / mL on ≥ 2 occasions during continuous ART of ≥ 1 years, with no blip of \>1000 HIV RNA copies / mL
- Karnofsky score ≥80
- Willingness and ability to provide informed consent for study participation
- Willingness to undergo all required study procedures
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Positive Research and the Gastroenterology Clinic at Harborview Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.