Lenacapavir for HIV
Trial Summary
Will I have to stop taking my current medications?
The trial requires you to stop taking certain medications, including specific antiarrhythmics, anticoagulants, anticonvulsants, antiretroviral agents, antimycobacterials, systemic corticosteroids, ergot derivatives, herbal products like St. John's wort, certain cholesterol medications, some narcotic analgesics, opioid dependence treatments, opioid antagonists, PDE-5 inhibitors, and certain sedatives. If you are on any of these, you may need to stop them to participate in the trial.
What data supports the effectiveness of the drug Lenacapavir for HIV treatment?
Lenacapavir has been shown to be effective in treating HIV, especially in people with multidrug-resistant HIV who have limited treatment options. Clinical trials demonstrated its ability to work well when combined with other HIV medications, and it was approved by the U.S. Food and Drug Administration for this purpose.12345
Is Lenacapavir safe for humans?
What makes the drug Lenacapavir unique for treating HIV?
Lenacapavir is unique because it is a first-in-class capsid inhibitor, which means it targets a different part of the HIV virus than other drugs. It can be given as an injection every six months, reducing the need for daily pills, which is especially helpful for people with multidrug-resistant HIV.14689
What is the purpose of this trial?
Pending...
Research Team
Chuen-Yen C Lau, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
This trial is for adults aged 18-75 with HIV who are in good health, have been on antiretroviral therapy (ART) for over 3 years with a suppressed viral load, and have a CD4+ T cell count above 200. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include recent illness, drug abuse, certain medication use, other infections like hepatitis B/C, and inability to undergo leukapheresis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenacapavir intensification or continue ART alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lenacapavir
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor