HIV-1-infectionNCT05584397
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
An observational study of HIV-1-infection and HIV Disease Progression, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1-infection, HIV Disease Progression, Inflammation
- What is being tested?
- Venipuncture, Targeted physical medical exam and Urine pregnancy test
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 28 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 9Show fewer
- Karnofsky score ≥80
- Willingness and ability to provide informed consent for study participation
- Willingness to undergo all required study procedures
Who cannot join
- Active malignancy including myelodysplastic syndrome, or myeloproliferative disease within 24 weeks prior to study entry
- Prior organ or bone marrow transplantation
- Diagnosed autoimmune disease
- Medical need for ongoing treatment with an immunosuppressive drug
- Diagnosis of AIDS (defined as any AIDS-defining opportunistic infection or cancer, or a history of blood CD4+ T cell count < 200/μL)
- Active opportunistic infection
Show all 22Show fewer
- 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
- History of medical non-compliance
- 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
- Using disallowed medications:
- Systemic corticosteroids
- Other immunosuppressive medications (e.g., cyclosporine, sirolimus, tacrolimus, pimecrolimus, tofacitinib)
- BMI > 40
- Pulmonary dysfunction.
- Use of narcotics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Washington Positive Research and the Gastroenterology Clinic at Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV (PWH) on Tenofovir-containing Versus NRTI-sparing ART
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.
Read more
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.
Read the detailed description
The study will be open-label, cross-sectional, two-cohort study (20 participants per cohort will be recruited).
Cohort 1: Tenofovir-containing ART (tenofovir disoproxil fumarate [TDF] OR tenofovir alafenamide [TAF] PLUS any other ART drugs) prescribed for daily use by participants' primary care providers.
Cohort 2: NRTI-sparing ART (specifically: rilpivirine PLUS dolutegravir OR rilpivirine PLUS cabotegravir) prescribed for daily use by participants' primary care providers.
The investigators plan to test type I/III IFN (interferon) pathway activation using Crystal digital PCR (Crystal-dPCR) to quantify mRNA copy numbers of ISG15 (ISG15 ubiquitin-like modifier), MX1 (MX dynamin like GTPase 1) and IFI6 (interferon alpha inducible protein 6). RNA will be isolated from the rectal and duodenal biopsies stored in RNALater using the RNeasy Fibrous Tissue Mini Kit (Qiagen) and from the PBMC using the RNeasy Plus Mini Kit (Qiagen). Crystal-dPCR will be performed on a 6-color Naica Crystal digital PCR instrument (Stilla Technologies).
The latent HIV reservoir will be measured in DNA derived from peripheral blood mononuclear cells (PBMCs) using a novel intact/defective proviral HIV DNA Crystal-dPCR assay developed jointly by the Hladik and Jerome groups in Seattle.
- Conditions
- HIV-1-infection, HIV Disease Progression, Inflammation, HIV
- Being tested
- Venipuncture, Targeted physical medical exam, Urine pregnancy test, Anoscopy, Esophagogastroduodenoscopy (EGD)
- Keywords
- HIV reservoir, Interferon Stimulated Genes, Tenofovir, Interferon, Duodenum, Blood, Rectum, NRTI
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenipunctureProcedure or surgery
Also called Peripheral blood draw by phlebotomy
Draw of peripheral blood (about 20 ml and 40 ml, during the screening and procedure visits, respectively).
Targeted physical medical examProcedure or surgery
Study participants will be undergoing a physical exam where vitals will be recorded (e.g. temperature, blood pressure, heart rate). The registered nurse (RN) will also perform auscultation of heart and lungs.
Study participants will be also asked to fill out a survey with questions related to his/her medical history, current use of medications, sexual history and substance abuse.
Urine pregnancy testProcedure or surgery
Women of childbearing potential will be asked to run an urine pregnancy test during the second (procedure) visit. Pregnant women will not be allowed to participate in the study.
AnoscopyProcedure or surgery
The anoscopy is an examination using a small, rigid, tubular instrument called anoscope (also called an anal speculum). This is inserted a few inches into the rectum in order to collect some small samples of mucosal tissue. We will collect 5 rectum biopsy samples and one cytobrush.
Esophagogastroduodenoscopy (EGD)Procedure or surgery
Also called Upper endoscopy
The EGD involves looking at the esophagus, stomach, and first and second portion of the duodenum. This procedure involves the use of an endoscope to remove small tissue samples. This procedure uses conscious sedation drugs given by a vein in the arm. The procedure takes about 1½-2 hours, including time for recovery. We will collect 5 duodenal biopsies and one cytobrush.
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir-containing ART | Cohort 1: Tenofovir-containing ART (tenofovir disoproxil fumarate [TDF] OR tenofovir alafenamide [TAF] PLUS any other ART drugs) prescribed for daily use by participants' primary care providers. Receives: Procedure: Venipuncture; Procedure: Targeted physical medical exam; Procedure: Urine pregnancy test; Procedure: Anoscopy; Procedure: Esophagogastroduodenoscopy (EGD) | |
| NRTI-sparing ART | Cohort 2: NRTI-sparing ART (specifically: rilpivirine PLUS dolutegravir OR rilpivirine PLUS cabotegravir) prescribed for daily use by participants' primary care providers. Receives: Procedure: Venipuncture; Procedure: Targeted physical medical exam; Procedure: Urine pregnancy test; Procedure: Anoscopy; Procedure: Esophagogastroduodenoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type I/III Interferon pathway activation
Quantification of the mRNA copy number of the following Interferon-Stimulated Genes (ISGs): ISG15 (ISG15 ubiquitin-like modifier), MX1 (MX dynamin-like GTPase 1) and IFI6 (interferon alpha inducible protein 6). Copy numbers will be determined by Crystal digital PCR (dPCR), using the levels of UBC (Ubiquitin C) mRNA copies as normalizers.
Measured: Biopsy samples to assess interferon pathway activation will be collected during surgery. The assessment of this outcome (the determination of mRNA copy number) will be done around within one year of completing sample collection.
Size of the latent intact proviral HIV reservoir in cell-associated HIV DNA (Ca-DNA)
Determination of size (copy number) of the HIV proviral intact reservoir using a recently published assay the Hladik's lab conjointly with Jerome's lab developed (reference: Levy et al., 2021, Cell Reports Medicine 2, 100243). This outcome will be expressed as intact HIV copy numbers (found in cell-associated HIV DNA) per 10^6 T cells. We will use a multiplexed digital PCR (dPCR) assay that simultaneously quantifies likely intact HIV-1 proviruses and T lymphocytes. We designed two triplex droplet digital PCR assays, each with 2 unique targets and 1 in common, and normalize the results to PCR-based T cell counts. Both HIV assays are specific, sensitive, and reproducible. Together, they estimate the number of proviruses containing all five primer-probe regions.
Measured: Blood samples to assess the latent HIV reservoir will be collected during surgery. The assessment of this outcome (the determination of HIV copy number) will be done around within one year of completing sample collection.
Size of the latent defective proviral HIV reservoir in cell-associated HIV DNA (Ca-DNA)
Determination of size (copy number) of the HIV proviral defective reservoir using a recently published assay the Hladik's lab conjointly with Jerome's lab developed (reference: Levy et al., 2021, Cell Reports Medicine 2, 100243). This outcome will be expressed as defective HIV copy numbers (found in cell-associated HIV DNA) per 10^6 T cells.
Measured: Blood samples to assess the latent HIV reservoir will be collected during surgery. The assessment of this outcome (the determination of HIV copy number) will be done around within one year of completing sample collection.
Secondary outcomes (1)
Composition of gastrointestinal microbiota
We will do 16s RNA sequencing in rectum and duodenum cytobrush samples to identify, classify and quantify gut microbiota.
Measured: Cytobrush samples to assess gut microbiota will be collected during surgery. The assessment of this outcome (the determination of 16s repertoire) will be done around within one year of completing sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Sep 2022
- Primary completion30 Jul 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, German Gornalusse, University of Washington
- Investigators
- German G Gornalusse, PhD, MSc, Principal investigator, University of WashingtonFlorian Hladik, MD, PhD, Principal investigator, University of WashingtonRomel D Mackelprang, PhD, MSc, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584397
- Sponsor's protocol ID
- STUDY00011699
- Other IDs
- R01AI134293, KL2TR002317
- Status last verified
- Apr 2026
- First submitted
- 5 Oct 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We may share information encompassing global transcriptome analysis (e.g. RNA-Seq data) derived from biopsy or peripheral blood mononuclear cells (PBMC) mRNA, DNA sequencing of the bacterial 16S RNA gene from cytobrush material (to determine microbial composition in duodenum or rectum) and HIV proviral sequencing (to characterize the HIV reservoir). HIV status and the size/structure of the HIV reservoir will be data that will be shared. Direct identifiers (e.g., names, telephone numbers, emails, social security numbers, medical record numbers, etc.) will not be shared. Data will be submitted to the National Institute of Health (NIH) Genomic Data repository, with unrestricted access (i.e. data will be made accessible to anyone via a public website). The data will be coded or anonymized prior to submission to NIH such that the identities of subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users.
Publications
Hughes SM, Levy CN, Calienes FL, Stekler JD, Pandey U, Vojtech L, Berard AR, Birse K, Noel-Romas L, Richardson B, Golden JB, Cartwright M, Collier AC, Stevens CE, Curlin ME, Holtz TH, Mugo N, Irungu E, Katabira E, Muwonge T, Lama JR, Baeten JM, Burgener A, Lingappa JR, McElrath MJ, Mackelprang R, McGowan I, Cranston RD, Cameron MJ, Hladik F. Treatment with Commonly Used Antiretroviral Drugs Induces a Type I/III Interferon Signature in the Gut in the Absence of HIV Infection. Cell Rep Med. 2020 Sep 22;1(6):100096. doi: 10.1016/j.xcrm.2020.100096.
PubMed 33015651
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV (PWH) on Tenofovir-containing Versus NRTI-sparing ART
- ClinicalTrials.gov ID
- NCT05584397
- Acronym / sponsor ID
- STUDY00011699
- Conditions
- HIV-1-infection, HIV Disease Progression, Inflammation, HIV
- Keywords
- HIV reservoir, Interferon Stimulated Genes, Tenofovir, Interferon, Duodenum, Blood, Rectum, NRTI
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be open-label, cross-sectional, two-cohort study (20 participants per cohort will be recruited).
Cohort 1: Tenofovir-containing ART (tenofovir disoproxil fumarate [TDF] OR tenofovir alafenamide [TAF] PLUS any other ART drugs) prescribed for daily use by participants' primary care providers.
Cohort 2: NRTI-sparing ART (specifically: rilpivirine PLUS dolutegravir OR rilpivirine PLUS cabotegravir) prescribed for daily use by participants' primary care providers.
The investigators plan to test type I/III IFN (interferon) pathway activation using Crystal digital PCR (Crystal-dPCR) to quantify mRNA copy numbers of ISG15 (ISG15 ubiquitin-like modifier), MX1 (MX dynamin like GTPase 1) and IFI6 (interferon alpha inducible protein 6). RNA will be isolated from the rectal and duodenal biopsies stored in RNALater using the RNeasy Fibrous Tissue Mini Kit (Qiagen) and from the PBMC using the RNeasy Plus Mini Kit (Qiagen). Crystal-dPCR will be performed on a 6-color Naica Crystal digital PCR instrument (Stilla Technologies).
The latent HIV reservoir will be measured in DNA derived from peripheral blood mononuclear cells (PBMCs) using a novel intact/defective proviral HIV DNA Crystal-dPCR assay developed jointly by the Hladik and Jerome groups in Seattle.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir-containing ART | – | Procedure: Venipuncture, Procedure: Targeted physical medical exam, Procedure: Urine pregnancy test, Procedure: Anoscopy, Procedure: Esophagogastroduodenoscopy (EGD)Cohort 1: Tenofovir-containing ART (tenofovir disoproxil fumarate [TDF] OR tenofovir alafenamide [TAF] PLUS any other ART drugs) prescribed for daily use by participants' primary care providers. |
| NRTI-sparing ART | – | Procedure: Venipuncture, Procedure: Targeted physical medical exam, Procedure: Urine pregnancy test, Procedure: Anoscopy, Procedure: Esophagogastroduodenoscopy (EGD)Cohort 2: NRTI-sparing ART (specifically: rilpivirine PLUS dolutegravir OR rilpivirine PLUS cabotegravir) prescribed for daily use by participants' primary care providers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- Active malignancy including myelodysplastic syndrome, or myeloproliferative disease within 24 weeks prior to study entry
- Prior organ or bone marrow transplantation
- Diagnosed autoimmune disease
- Medical need for ongoing treatment with an immunosuppressive drug
- Diagnosis of AIDS (defined as any AIDS-defining opportunistic infection or cancer, or a history of blood CD4+ T cell count < 200/μL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenipunctureAlso: Peripheral blood draw by phlebotomyDraw of peripheral blood (about 20 ml and 40 ml, during the screening and procedure visits, respectively). | Procedure or surgery | NRTI-sparing ART, Tenofovir-containing ART |
| Targeted physical medical examStudy participants will be undergoing a physical exam where vitals will be recorded (e.g. temperature, blood pressure, heart rate). The registered nurse (RN) will also perform auscultation of heart and lungs. Study participants will be also asked to fill out a survey with questions related to his/her medical history, current use of medications, sexual history and substance abuse. | Procedure or surgery | NRTI-sparing ART, Tenofovir-containing ART |
| Urine pregnancy testWomen of childbearing potential will be asked to run an urine pregnancy test during the second (procedure) visit. Pregnant women will not be allowed to participate in the study. | Procedure or surgery | NRTI-sparing ART, Tenofovir-containing ART |
| AnoscopyThe anoscopy is an examination using a small, rigid, tubular instrument called anoscope (also called an anal speculum). This is inserted a few inches into the rectum in order to collect some small samples of mucosal tissue. We will collect 5 rectum biopsy samples and one cytobrush. | Procedure or surgery | NRTI-sparing ART, Tenofovir-containing ART |
| Esophagogastroduodenoscopy (EGD)Also: Upper endoscopyThe EGD involves looking at the esophagus, stomach, and first and second portion of the duodenum. This procedure involves the use of an endoscope to remove small tissue samples. This procedure uses conscious sedation drugs given by a vein in the arm. The procedure takes about 1½-2 hours, including time for recovery. We will collect 5 duodenal biopsies and one cytobrush. | Procedure or surgery | NRTI-sparing ART, Tenofovir-containing ART |
Primary outcome
Type I/III Interferon pathway activation
Time frame: Biopsy samples to assess interferon pathway activation will be collected during surgery. The assessment of this outcome (the determination of mRNA copy number) will be done around within one year of completing sample collection.
Quantification of the mRNA copy number of the following Interferon-Stimulated Genes (ISGs): ISG15 (ISG15 ubiquitin-like modifier), MX1 (MX dynamin-like GTPase 1) and IFI6 (interferon alpha inducible protein 6). Copy numbers will be determined by Crystal digital PCR (dPCR), using the levels of UBC (Ubiquitin C) mRNA copies as normalizers.
Size of the latent intact proviral HIV reservoir in cell-associated HIV DNA (Ca-DNA)
Time frame: Blood samples to assess the latent HIV reservoir will be collected during surgery. The assessment of this outcome (the determination of HIV copy number) will be done around within one year of completing sample collection.
Determination of size (copy number) of the HIV proviral intact reservoir using a recently published assay the Hladik's lab conjointly with Jerome's lab developed (reference: Levy et al., 2021, Cell Reports Medicine 2, 100243). This outcome will be expressed as intact HIV copy numbers (found in cell-associated HIV DNA) per 10^6 T cells. We will use a multiplexed digital PCR (dPCR) assay that simultaneously quantifies likely intact HIV-1 proviruses and T lymphocytes. We designed two triplex droplet digital PCR assays, each with 2 unique targets and 1 in common, and normalize the results to PCR-based T cell counts. Both HIV assays are specific, sensitive, and reproducible. Together, they estimate the number of proviruses containing all five primer-probe regions.
Size of the latent defective proviral HIV reservoir in cell-associated HIV DNA (Ca-DNA)
Time frame: Blood samples to assess the latent HIV reservoir will be collected during surgery. The assessment of this outcome (the determination of HIV copy number) will be done around within one year of completing sample collection.
Determination of size (copy number) of the HIV proviral defective reservoir using a recently published assay the Hladik's lab conjointly with Jerome's lab developed (reference: Levy et al., 2021, Cell Reports Medicine 2, 100243). This outcome will be expressed as defective HIV copy numbers (found in cell-associated HIV DNA) per 10^6 T cells.
1 secondary outcome
Composition of gastrointestinal microbiota
Time frame: Cytobrush samples to assess gut microbiota will be collected during surgery. The assessment of this outcome (the determination of 16s repertoire) will be done around within one year of completing sample collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 33015651Hughes SM, Levy CN, Calienes FL, Stekler JD, Pandey U, Vojtech L, Berard AR, Birse K, Noel-Romas L, Richardson B, Golden JB, Cartwright M, Collier AC, Stevens CE, Curlin ME, Holtz TH, Mugo N, Irungu E, Katabira E, Muwonge T, Lama JR, Baeten JM, Burgener A, Lingappa JR, McElrath MJ, Mackelprang R, McGowan I, Cranston RD, Cameron MJ, Hladik F. Treatment with Commonly Used Antiretroviral Drugs Induces a Type I/III Interferon Signature in the Gut in the Absence of HIV Infection. Cell Rep Med. 2020 Sep 22;1(6):100096. doi: 10.1016/j.xcrm.2020.100096.
- Individual participant dataSharing planned: Yes. We may share information encompassing global transcriptome analysis (e.g. RNA-Seq data) derived from biopsy or peripheral blood mononuclear cells (PBMC) mRNA, DNA sequencing of the bacterial 16S RNA gene from cytobrush material (to determine microbial composition in duodenum or rectum) and HIV proviral sequencing (to characterize the HIV reservoir). HIV status and the size/structure of the HIV reservoir will be data that will be shared. Direct identifiers (e.g., names, telephone numbers, emails, social security numbers, medical record numbers, etc.) will not be shared. Data will be submitted to the National Institute of Health (NIH) Genomic Data repository, with unrestricted access (i.e. data will be made accessible to anyone via a public website). The data will be coded or anonymized prior to submission to NIH such that the identities of subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
German G Gornalusse, PhD, MSc principal investigator
University of Washington
Florian Hladik, MD, PhD principal investigator
University of Washington
Romel D Mackelprang, PhD, MSc principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and HIV Disease Progression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type I/III Interferon pathway activation (time frame: Biopsy samples to assess interferon pathway activation will be collected during surgery. The assessment of this outcome (the determination of mRNA copy number) will be done around within one year of completing sample collection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05584397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.