Trial reportThe lancet. HIV2024
Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study.
Trial report in The lancet. HIV, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03497676 (Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents), which is not on this map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents
Who cites it
17 citing papers in PubMed, 26 citations in OpenAlex.
- Sustained Virologic Suppression After Discontinuation of Long-acting Cabotegravir/Rilpivirine: A Two-case Series Highlighting Unexpected Heterogeneity in Pharmacokinetics and Viral Control.Open forum infectious diseases · 2026Trial
- Trial
- Trial
- Safety, tolerability, and acceptability of long-acting injectable cabotegravir for HIV prevention in cisgender female adolescents (HPTN 084-01): a single-arm, open-label, phase 2b trial.The lancet. HIV · 2025Trial
- Trial
- Narrative Review of Two-Drug Regimens in Modern HIV Care: Driving Innovation, Flexibility, and Quality of Life.Infectious diseases and therapy · 2026Review
- Long-Acting Therapeutics in Pediatric Health: Bridging Innovation and Access.Clinical pharmacology and therapeutics · 2026Review
- External Evaluation of Population Pharmacokinetic Models of Cabotegravir, During Its Oral and Intramuscular Administration in HIV-Infected Patients.CPT: pharmacometrics & systems pharmacology · 2026Observational
- Implementation of Long-Acting Cabotegravir/Rilpivirine in US HIV Care Settings: Results From a National Survey of Frontline Clinicians.Open forum infectious diseases · 2026Article
- Review
- Long-Acting Cabotegravir and Rilpivirine in Patients With HIV With Solid Organ Transplantation: A Case Series.Open forum infectious diseases · 2025Article
- Attitudes and eligibility of long-acting cabotegravir/rilpivirine treatment among youth living with HIV in a clinical and national cohort in Thailand: a cross-sectional study.AIDS research and therapy · 2025Article
- The cumulative prevalence of HIV-1 drug resistance in perinatal HIV.AIDS (London, England) · 2025Observational
- The Meandrous Route of Rilpivirine in the Search for the Miraculous Drug to Treat HIV Infections.Viruses · 2025Article
- Mucosal immunity in acute HIV: a review of recent work.Current opinion in HIV and AIDS · 2025Review
- Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control.AIDS research and treatment · 2025Review
- Optimising Paediatric HIV Treatment: Recent Developments and Future Directions.Paediatric drugs · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 18 institutions in 7 countries.
Funding
Abstract
backgroundCombined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents.
methodsIn this phase 1/2, multicentre, open-label, non-comparative, dose-finding study, virologically suppressed adolescents (aged 12-17 years; weight ≥35 kg; BMI ≤31·5 kg/m
findingsBetween March 19, 2019, and Nov 25, 2021, 55 participants were enrolled: 30 in cohort 1C and 25 in cohort 1R. At week 16, 28 (97%, 95% CI 82-100) of the 29 dose-evaluable participants in cohort 1C and 21 (91%; 72-99) of the 23 dose-evaluable participants in cohort 1R had reported at least one adverse event, with the most common being injection-site pain (nine [31%] in cohort 1C; nine [39%] in cohort 1R; none were severe). One (4%, 95% CI 0-22) participant in cohort 1R had an adverse event of grade 3 or higher, leading to treatment discontinuation, which was defined as acute rilpivirine-related allergic reaction (self-limiting generalised urticaria) after the first oral dose. No deaths or life-threatening events occurred. In cohort 1C, the week 2 median cabotegravir AUC
interpretationStudy data support using long-acting cabotegravir or long-acting rilpivirine, given every 4 weeks or 8 weeks, per the adult dosing regimens, in virologically suppressed adolescents aged 12 years and older and weighing at least 35 kg.
fundingThe National Institutes of Health and ViiV Healthcare.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.