Cabotegravir + Rilpivirine Injections for HIV/AIDS
What You Need to Know Before You Apply
What is the purpose of this trial?
The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it involves switching from your current HIV treatment to a new regimen of cabotegravir and rilpivirine injections. You may need to stop your current antiretroviral therapy if you are selected to switch to the new treatment.
Is the combination of Cabotegravir and Rilpivirine safe for humans?
Cabotegravir and Rilpivirine injections are generally considered safe for humans, with studies showing they are well-tolerated despite frequent injection-site reactions. These injections have been tested in clinical trials for HIV treatment, and while they are effective, some challenges like managing missed doses and drug interactions remain.12345
What makes the Cabotegravir + Rilpivirine treatment unique for HIV/AIDS?
What data supports the effectiveness of the drug Cabotegravir + Rilpivirine for HIV/AIDS?
Research shows that the combination of cabotegravir and rilpivirine as long-acting injections is effective in maintaining HIV-1 viral suppression, similar to traditional oral therapies. It is particularly beneficial for people who have trouble sticking to daily oral medication, as it requires less frequent dosing.13456
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
ViiV Healthcare
Are You a Good Fit for This Trial?
Adults over 18 with HIV-1 who've been on a stable antiretroviral regimen for at least 6 months, showing viral suppression. They must not be pregnant or breastfeeding and agree to use effective contraception. Excluded are those with certain medical conditions, history of specific drug use, or participation in other trials.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral CAB 30 mg + RPV 25 mg once daily for 4 weeks, followed by monthly CAB LA + RPV LA injections
Extension
Participants who continued their current ART regimen have the option to switch to CAB LA + RPV LA injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cabotegravir
- Rilpivirine
Cabotegravir is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
ViiV Healthcare
Lead 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
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Pharmaceuticals
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University