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New treatment option for HIV Infections
Official title Dasatinib for HIV-1 Reservoir Reduction
ClinicalTrials.gov ID: NCT07342491
What this study is testing
What is Dasatinib?
Dasatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 36 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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
See the full eligibility criteria
- 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
- QTc interval \<450 milliseconds on EKG performed at screening visit
- Women who are able to become pregnant must have a negative serum or urine pregnancy test at screening and within 48 hours prior to study entry
- Individuals (male or female) who are having sex that could lead to pregnancy, must agree to use at least two effective means of contraception when engaging in sexual activities that can result in pregnancy, from the...
- Able to swallow pills without difficulty.
- Ability and willingness of participant or legally authorized representative to provide informed consent
- Ability and willingness of participant to continue same ART regimen throughout the study
- 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
- Exposure to anticoagulant or anti-platelet medications in the 16 weeks prior to study entry
- Active use of medications known to prolong the QT interval
- Known family history of Long QT Syndrome in a first-degree relative (i.e., parent, offspring, or sibling)
- Active use of medications known to moderately or strongly induce or inhibit CYP3A4, including ART regimens that contain protease inhibitors, efavirenz, etravirine, or cobicistat at the time of screening or study entry
- Current substance use which is likely to interfere with the conduct of the study
- Anticipated conflict or inability to attend and complete all protocol-scheduled study visits and assessments
- Known allergy/sensitivity or any hypersensitivity to components of dasatinib or its formulation
- Active use of azithromycin, Ondansetron, Pentamidine at study entry
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Cleveland, Ohio, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Cleveland, Ohio, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.