Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Thigh Injections of Cabotegravir + Rilpivirine in Virally Suppressed Adults With HIV-1: A Substudy of the Phase 3b ATLAS-2M Study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Accelerating Low-Barrier Use of Long-Acting Antiretroviral Therapy to Maximize Impact in People with HIV and Viremia or Adherence Challenges.Current HIV/AIDS reports · 2026Review
- Facilitators and Barriers to Home-Based Long-Acting Injectable Antiretroviral Therapy: Clinician Perspectives from the INVITE-Home Study.AIDS and behavior · 2026Article
- Strategies to Manage Dosing Deviations and Interruptions of Cabotegravir Long-Acting Intramuscular Injections.Clinical pharmacology in drug development · 2026Article
- Comparing Interest in Thigh Administration of Long-acting Cabotegravir/Rilpivirine Among Hypothetical Users, Early Adopters, and Trial Participants With Experience.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Article
Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
backgroundCabotegravir + rilpivirine (CAB + RPV) administered via intramuscular gluteal injections is the first complete long-acting regimen for maintaining human immunodeficiency virus type 1 (HIV-1) virologic suppression. We present substudy results on short-term repeat intramuscular CAB + RPV long-acting thigh injections in participants with ≥3 years of experience with gluteal administration during the ATLAS-2M study.
methodsSubstudy phases included screening, thigh injection (day 1-week 16), and return to gluteal injection (week 16-week 24). The injection schedule was unchanged from the main study. Outcomes included pharmacokinetics, safety, tolerability, efficacy, and patient-reported outcomes. Pharmacokinetic parameters were determined using noncompartmental analysis and mixed-effects modeling. Population pharmacokinetic simulations were performed.
resultsThere were 118 participants. In the arm that received injections every 2 months (Q2M), first CAB thigh injection including area under the concentration-time curve and maximum observed concentration (Cmax) and first RPV thigh injection Cmax and all last RPV thigh injection parameters were statistically higher vs gluteal injections (paired comparison). No significant differences occurred with once-monthly (QM) dosing. No participants had HIV-1 RNA ≥50 copies/mL after thigh injections. Overall, 4%-7% of injection site reactions (ISRs) were grade 3. Five participants withdrew due to an ISR or injection intolerability. Overall, 30% preferred thigh vs gluteal injections. Simulations demonstrated the potential for chronic/continuous QM or ≤2 consecutive Q2M thigh injections.
conclusionsThese data demonstrate the potential use of chronic/continuous QM and rotational/short-term QM or Q2M (≤4 months of continuous dosing), CAB + RPV long-acting intramuscular thigh administration for HIV-1 treatment.
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