Long-Acting Antiretroviral Therapy for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you must not require any medication that is prohibited with the study medication, so it's best to discuss your current medications with the study team.
Is long-acting antiretroviral therapy for HIV safe for humans?
Long-acting antiretroviral therapy using cabotegravir (CAB-LA) and rilpivirine (RPV-LA) has been generally well-tolerated in clinical trials, with safety profiles similar to placebo, meaning they did not cause more side effects than a non-active treatment. These treatments have been approved for use in people with HIV who have their virus under control, and further studies are ongoing to confirm their safety in broader populations.12345
How is the long-acting antiretroviral therapy for HIV different from other treatments?
What data supports the effectiveness of the long-acting antiretroviral therapy for HIV?
Who Is on the Research Team?
Aadia Rana, M.D.
Principal Investigator
Alabama CTU
Are You a Good Fit for This Trial?
This trial is for adults with HIV who've struggled to stick to their oral ART medication. They must have a recent history of poor viral control or missed clinic visits, no resistance to certain HIV drugs, and acceptable blood test results. Pregnant or breastfeeding individuals, those with allergies to study drugs, chronic hepatitis C requiring treatment during the study, active hepatitis B infection, or conditions affecting drug injections are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive a SOC oral ART regimen with conditional economic incentives for up to 24 weeks
Randomization and Treatment
Participants are randomized to either LA ART or SOC. LA ART involves oral RPV + CAB for 4 weeks (optional) followed by RPV-LA + CAB-LA every 4 weeks. SOC continues for 52 weeks.
Continuation/Crossover
Participants on LA ART continue for 52 weeks. SOC participants may cross over to LA ART if criteria are met.
Observation
Participants are followed on locally sourced oral ART for up to 52 weeks. Option to restart LA ART if available.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- CAB-LA Loading Dose
- CAB-LA Maintenance Dose
- Oral CAB
- Oral RPV
- RPV-LA Loading Dose
- RPV-LA Maintenance Dose
- Standard of Care (SOC) Oral ART
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
ViiV Healthcare
Industry Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration