Is NCT07342491 recruiting in Cleveland, OH?

Yes, NCT07342491 is currently enrolling participants at its Cleveland, OH location. This hiv infections clinical trial is accepting qualified participants.

How do I join the hiv infections clinical trial in Cleveland?

To join this clinical trial in Cleveland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cleveland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV Infections Clinical Trial in Cleveland, OH: Dasatinib (Phase 1)

About This HIV Infections Study in Cleveland

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.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion 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 time of enrollment through 60 days following the last dose of dasatinib

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

Exclusion Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT07342491) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV Infections Treatment Options in Cleveland, OH

If you're searching for hiv infections treatment options in Cleveland, OH, this clinical trial (NCT07342491) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced hiv infections specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv infections clinical trials near you to find additional studies recruiting in your area.

HIV Infections Clinical Trial in Cleveland, OH

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