Comparison · NCT04840199-6864cb70
Letermovir vs No Anti-CMV Treatment: Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Letermovir vs No Anti-CMV Treatment: Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure. Trial comparisons, record NCT04840199-6864cb70. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04840199-6864cb70
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.263 | 0.118 | 0.488 | wilson | |
| Risk in group 2 | 0.0909 | 0.0253 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0.172 | -0.0646 | 0.406 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.89 | 0.633 | 13.2 | log | |
| Odds ratio, group 1 over group 2 | 3.57 | 0.604 | 21.1 | log | |
| Number needed to treat, for one more participant with the outcome on Letermovir than on No Anti-CMV Treatment | 5.81 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Letermovir | Participants randomized to letermovir for 48 weeks followed by 12 weeks off letermovir~Letermovir Oral Tablet: 480 mg administered orally once daily with or without food | 5 | 19 | OG000 |
| Group 2 | No Anti-CMV Treatment | Participants randomized to no study intervention for 60 weeks | 2 | 22 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure
- Description
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.~Confirmed virologic failure was defined as two consecutive HIV-1 RNA levels ≥200 copies/mL by real-time HIV-1 RNA testing. Participants with a plasma HIV-1 RNA ≥200 copies/mL at any visit had a confirmatory viral load obtained as soon as possible but within 14 days after the first sample was drawn, if possible. If the consecutive measurement of HIV-1 RNA was also ≥200 copies/mL, the participant was considered to have confirmed virologic failure.
- Time frame
- Measured from study entry through Week 48
- Population
- Modified intent to treat population: all eligible, randomized participants excluding letermovir arm participants who did not initiate study treatment.
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
- NCT number
- NCT04840199
- Phases
- PHASE2
- Conditions
- HIV Infections, Cytomegalovirus, CMV
- Interventions
- Letermovir Oral Tablet
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2025-03-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04840199?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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