Dasatinib for HIV-1 Reservoir Reduction

NCT07342491 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: A5413
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV "reservoir." It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Adults 18 years or older who have been on ART for at least 48 months and have had a suppressed HIV-1 viral load for at least 36 months may be able to join. People will be randomly assigned to take dasatinib 100 mg by mouth once a day or a look-alike substance with no drug, called a placebo, for 12 weeks. Neither participants nor researchers will know who gets which (double-blind). The study team will do regular health checks and blood tests to track safety, tolerability, the HIV reservoir, and changes in immune cells. The study lasts 36 weeks total: 12 weeks of treatment and 24 weeks of follow-up, with clinic visits and possible phone calls. Fourteen people will take part; eight will get dasatinib and six will get placebo. Dasatinib may lower the HIV reservoir, but this is not guaranteed. All medicines can cause side effects, called adverse events (AE). The study team will watch closely and provide medical support. Joining is your choice, and you can leave at any time. If you leave, the team will talk with you about next steps for your care.

Conditions

HIV Infections

Keywords

Antiretroviral Therapy (ART); Viral Persistence; HIV

Outcome Measures

Primary Outcomes (2)

• Change in intact HIV-1 reservoir size

  Change in the intact HIV-1 reservoir from baseline to week 12, measured by the Intact Proviral DNA Assay (IPDA), or the best available assay at the time of testing if IPDA is not available.

  Baseline and week 12

• Number of Study treatment-related adverse events

  Occurrence of any study treatment-related serious adverse event (SAE), any Grade 2 or higher adverse event (AE), or any AE that leads to permanent discontinuation of study treatment, regardless of grade.

  From first dose through week 36

Secondary Outcomes (4)

• Anti-proliferative effects after 1 week of dasatinib

  Baseline and week 1

• Changes in T cell subset composition and cellular Ki-67 expression

  Baseline to week 12

• Changes in HIV-1 cell-associated RNA transcripts in total CD4+ T cells

  Baseline to week 12

• Changes in low-level plasma viremia (single-copy assay)

  Baseline to week 12

Study Arms (2)

Arm 1: dasatinib

EXPERIMENTAL

100 mg by mouth daily

Drug: Dasatinib

Arm 2: Placebo

PLACEBO COMPARATOR

Placebo for dasatinib

Other: Placebo

Interventions

Dasatinib DRUG

will be administered as one 100 mg capsule (over-encapsulated tablet) orally once daily for 12 weeks

Arm 1: dasatinib

Placebo OTHER

Placebo for dasatinib will be administered as one placebo capsule (over-encapsulated tablet) orally once daily for 12 weeks

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection
• Active antiretroviral therapy received continuously for 48 months (or longer)
• CD4+ cell count \>450 cells/mm3 obtained within 12 months prior to study entry
• Plasma HIV-1 RNA level below the lower limit of quantification within 90 days prior to study entry
• Plasma HIV-1 RNA levels below the lower limit of quantification for \>36 months at time of study entry
• The following laboratory values obtained within 90 days prior to entry:
• Absolute neutrophil count (ANC) above the lower limit of normal
• Hemoglobin above the lower limit of normal
• Platelet count above the lower limit of normal
• Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase \<1.5 x ULN
• Total bilirubin \<1.5 x ULN
• Negative hepatitis B virus (HBV) surface antigen (HBsAg)
• Negative HBV core antibody with one exception: individuals with positive HBV core antibody and HBV surface antibody are eligible for enrollment
• Negative hepatitis C virus (HCV) antibody (anti-HCV) or, if the anti-HCV is positive, a negative HCV RNA PCR
• Estimated glomerular filtration rate (eGFR) \>70 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) 2021 equation or serum creatinine \<1.2 x ULN

You may not qualify if:

• Pre-ART viral load known to be \<2000 copies/mL (HIV controller)
• Known to have initiated ART during acute HIV infection
• Presence of a drug-resistant virus with no alternative ART regimens available in the event that current ART regimen becomes compromised as a result of this study
• Current pregnancy or breastfeeding or pregnancy planning during study participation
• Recent hospitalization or surgery within 90 days prior to entry
• Recent infection requiring intravenous antibiotics within 90 days prior to entry
• Any evidence of hepatic impairment
• Any known prior (lasting \>180 days) or current history of gastrointestinal-related diseases
• Active malignancy including myelodysplastic syndrome or myeloproliferative disease.
• Any known prior (lasting \>180 days) or current history of hematologic illness
• Any known prior (lasting \>180 days) or current history of cardiac-related diseases
• Untreated hypothyroidism
• Treatment for TB within the past 90 days.
• Current respiratory disease requiring supplemental oxygen
• Exposure to any systemic immunomodulatory drug (including maraviroc) in the 16 weeks prior to study entry

Sponsors & Collaborators

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

Study Sites (3)

Northwestern University CRS (Site # 2701)

Chicago, Illinois, 60611, United States

Location

2501, Case CRS

Cleveland, Ohio, 44106, United States

Location

1401, University of Washington Positive Research CRS

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 15, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): May 12, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.
• Access Criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections). * For what types of analyses? To achieve aims in the proposal approved by the ACTG. * By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.

Locations

US (3)