Trial reportThe lancet. HIV2026
Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study.
Trial report in The lancet. HIV, 2026. 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 3 papers.
What it found
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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
3 citing papers in PubMed.
- Trial
- Long-Acting Injectable Antiretroviral Therapies for HIV Treatment and Prevention: Clinical Pharmacology, Recent Advances and Future Opportunities.Journal of clinical pharmacology · 2026Review
- A turning point for youth HIV care in the United States: tailored strategies for adolescents and young adults.Critical public health · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors.
Funding
Abstract
backgroundCombined intramuscular long-acting cabotegravir-rilpivirine is the first long-acting combination antiretroviral therapy regimen approved for adults with HIV. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT 2017)-More Options for Children and Adolescents (MOCHA) study assessed safety, acceptability, tolerability, antiviral activity, and pharmacokinetics of these drugs in adolescents with HIV-1. Here we present secondary outcome data up to week 48.
methodsIn this phase 1/2, open-label, non-comparative, dose-finding trial conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA, virologically suppressed (HIV-1 RNA <50 copies per mL) adolescents (aged 12-17 years; weight ≥35 kg) with HIV-1 switched prestudy antiretrovirals to 4 weeks of daily oral 30 mg cabotegravir and 25 mg rilpivirine, followed by 600 mg cabotegravir and 900 mg rilpivirine long-acting intramuscular (3 mL each) injections in the contralateral gluteus medius at week 4 and week 8, and then every 8 weeks. Secondary outcomes assessed here were grade 3 or worse adverse event, virological failure (including HIV-1 RNA ≥50 copies per mL and ≥200 copies per mL per the US Food and Drug Administration snapshot algorithm), and pharmacokinetic measures including cabotegravir and rilpivirine predose concentration assessment. This trial is registered with ClinicalTrials.gov, NCT03497676.
findingsBetween July 26, 2021, and Aug 27, 2022, 44 of 55 participants who had participated in cohort 1 and 100 of 115 screened study-naive participants were enrolled into cohort 2 of the study. 74 (51%) of 144 participants were female and 70 (49%) male, median age was 15 years (range 12-17), BMI 19·5 kg/m
interpretationWeek 48 data from the first virologically suppressed adolescents with HIV-1 who switched from daily oral to intramuscular cabotegravir and intramuscular rilpivirine every 8 weeks showed favourable safety, pharmacokinetics, and virological suppression informing both real-world use, where approved, and ongoing regulatory submissions, where approval is pending.
fundingNational Institutes of Health and ViiV Healthcare.
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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.