Trial reportAIDS (London, England)2026
Efficacy and safety of doravirine/islatravir in heavily treatment-experienced participants living with HIV-1: results from a randomized trial.
Trial report in AIDS (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04233216 (A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir), which is not on this map. Cited by 2 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.
A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
Who cites it
2 citing papers in PubMed.
- Doravirine/Islatravir: First Approval.Drugs · 2026Article
- Doravirine and islatravir for HIV-1 treatment: A systematic review and meta-analysis with GRADE assessment.Therapeutic advances in infectious diseaseArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study evaluated the efficacy (day 8) and safety (week 49) of doravirine/islatravir (DOR/ISL; 100 mg/0.75 mg) plus baseline antiretroviral therapy (ART) and optimized background therapy (OBT) in heavily treatment-experienced (HTE) adults living with detectable HIV-1 RNA. DESIGN AND
methodsHTE adults with confirmed plasma viral load more than 500 copies/ml receiving a stable ART regimen for at least 3 months were randomly assigned 1 : 2 : 1 : 1 to receive once-daily ISL alone, DOR alone, DOR/ISL, or matching placebo for 7 days; at day 8, baseline ART was optimized and all participants received DOR/ISL and OBT through week 49. The primary efficacy endpoint was percentage of participants receiving DOR/ISL achieving at least 0.5 log 10 decline in viral load from baseline (day 1) to day 8. Secondary efficacy endpoints included HIV-1 RNA levels and CD4 + T-cell counts through week 49.
resultsThirty-five of the planned 100 participants were enrolled; most were White (57.1%) and men (77.1%) with median age of 50 years. From days 1 to 8, an at least 1.0 log 10 decrease in HIV-1 RNA was achieved in 85.7% of the DOR/ISL group compared with 0 in the placebo group. At week 49, HIV-1 RNA less than 50 copies/ml was achieved in 22 participants (71%) and the mean increase in CD4 + T-cell count was 87 cells/μl. Adverse events were reported in 29 participants (82.9%) through week 49; 9 (25.7%) were considered related to DOR/ISL.
conclusionDOR/ISL plus OBT improved HIV-1 suppression in HTE adults living with HIV-1 and was generally well tolerated. CLINICALTRIALSGOV: NCT04233216.
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