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New treatment option for Human Immunodeficiency Virus
Official title Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
ClinicalTrials.gov ID: NCT06819176
What this study is testing
What is Lenacapavir?
Lenacapavir is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for human immunodeficiency virus.
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
- Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- Any clinically significant acute or chronic medical condition (eg, autoimmune diseases, cirrhosis, active malignancy that may require systemic...
- 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...
- Pregnancy or lactation.
See the full eligibility criteria
Who can join
- 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...
- 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) over 48 weeks prior to screening may be included provided they satisfy the...
- 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...
- 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...
- Contraceptive subdermal implant.
- Intrauterine device or intrauterine system.
- Combined estrogen and progestogen oral contraceptive.
- Injectable progestogen.
- Contraceptive vaginal ring.
- Percutaneous contraceptive patches.
What rules you out
- 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...
- 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...
- 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...
- 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
- Tramadol
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 2 years 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.