Is NCT06819176 recruiting in Bethesda, MD?

Yes, NCT06819176 is currently recruiting participants at its Bethesda, MD location. This human immunodeficiency virus clinical trial is actively enrolling qualified participants.

How do I join the human immunodeficiency virus clinical trial in Bethesda?

To join this clinical trial in Bethesda, 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 Bethesda 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.

Human Immunodeficiency Virus Clinical Trial in Bethesda, MD

About This Human Immunodeficiency Virus Study in Bethesda

Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART. Objective: To test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART. Eligibility: People aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART. Design: Participants will have 13 clinic visits over 2 years. Participants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study. Participants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube. Two-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study. ...

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

Who Can Participate

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

Able to provide informed consent.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Aged 18 years to 75 years.

In generally good health with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider while participating in the study.

Confirmed HIV-1 infection.

Total HIV DNA reservoir size greater than 300 copies/106 CD4+ T cells.

CD4+ T cell count \>200 cells/mm\^3 at screening.

Documentation of continuous ART treatment \>3 years with suppression of plasma viral level below the limit of quantitation (\<40 copies/mL). Individuals with \<= 2 blips (\>40 copies/mL) over 48 weeks prior to screening may be included provided they satisfy the following criteria:

The blips are \<=200 copies/mL.

Succeeding viral levels return to below the limit of quantification (\<40 copies/mL) on subsequent testing.

For individuals who can become pregnant (ie, participants who have not been postmenopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy), must have a negative pregnancy test at screening and within 48 hours prior to day 0. Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy.

Participants who can become pregnant must agree to use 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy from 10 days prior to the first dose of lenacapavir through study follow up. Acceptable methods of contraception include the following:

Contraceptive subdermal implant.

Intrauterine device or intrauterine system.

Combined estrogen and progestogen oral contraceptive.

Injectable progestogen.

Contraceptive vaginal ring.

Percutaneous contraceptive patches.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

History of AIDS-defining illness within 3 years prior to enrollment.

History of systemic corticosteroids (eg, an equivalent dose of prednisone of \>20 mg daily for \>14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the principal investigator within the last 6 months.

Any clinically significant acute or chronic medical condition (eg, autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation.

Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen or hepatitis C virus (HCV) RNA in blood. NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible.

Pregnancy or lactation.

Any licensed vaccine (eg, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to the study enrollment.

Receipt of other investigational study agents within 28 days of enrollment and at any time during the study, including any experimental non-HIV vaccination within 2 weeks prior to enrollment.

Systemic immunosuppressive medications received within 3 months prior to enrollment. The following are not excluded:

Corticosteroid nasal spray or inhaler.

Topical corticosteroids for mild, uncomplicated dermatitis.

Oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy 10 days, with completion in 30 days prior to enrollment).

Cyclosporine eye drops

Active drug or alcohol abuse or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.

Laboratory abnormalities in the parameters listed below:

Absolute neutrophil count \<1,000 cells/mm\^3

Hemoglobin \<10 g/dL

Platelet count \<100,000 cells/mm\^3

ALT \>1.5 x ULN

AST \>1.5 x ULN

Total bilirubin \>1.5 x ULN

Estimated glomerular filtration rate \<30 mL/min/1.73m\^2

Inability to undergo leukapheresis due to poor venous access or other medical conditions.

Concurrent treatment with any of the medications listed below:

Antiarrhythmics: digoxin

Anticoagulants: direct oral anticoagulants (DOACs), rivaroxaban, dabigatran, edoxaban

Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin

Antiretroviral Agents: atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, tipranavir/ritonavir

Antimycobacterials: Rifabutin, rifampin, rifapentine

Corticosteroids (systemic): dexamethasone, hydrocortisone/cortisone

Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine

Herbal products: St. John's wort c (Hypericum perforatum)

HMG-CoA reductase inhibitors: lovastatin simvastatin

Narcotic analgesics metabolized by CYP3A: fentanyl, oxycodone

Narcotic analgesic for treatment of opioid dependence: buprenorphine, methadone

Opioid antagonist: naloxegol

Phosphodiesterase-5 (PDE-5) inhibitors: sildenafil, tadalafil, vardenafil

Sedatives/Hypnotics: midazolam (oral), triazolam

Past or current medical findings that are not listed above, which, in the opinion of the investigator, may pose additional risk from participation in the study, may interfere with the individual's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study. Co-enrollment guidelines: Co-enrollment in other trials or protocols involving apheresis is restricted, other than enrollment on observational studies. Co-enrollment in an interventional trial will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.

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 Bethesda?

Yes, this clinical trial (NCT06819176) has an active research site in Bethesda, MD 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.

Human Immunodeficiency Virus Treatment Options in Bethesda, MD

If you're searching for human immunodeficiency virus treatment options in Bethesda, MD, this clinical trial (NCT06819176) 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 Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced human immunodeficiency virus 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 human immunodeficiency virus clinical trials near you to find additional studies recruiting in your area.

Human Immunodeficiency Virus Clinical Trial in Bethesda, MD

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