Trial · NCT04840199
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.
NCT04840199, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2025-03-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04840199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04840199
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections, Cytomegalovirus, CMV
- Interventions
- Letermovir Oral Tablet
- First posted
- 2021-04-09
- Last updated
- 2025-03-04
- Results first posted
- 2025-03-04
- Limitations and caveats
- Limitations include the open-label design and the premature study closure leading to a small sample size and differential time in the treatment phase between the two arms.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change (Absolute) in sTNFRII | Measured at Baseline and Weeks 46 and 48 | The absolute change in sTNFRII from Baseline (average of study entry and treatment initiation visits) to Week 46/48 (average of Week 46 and Week 48), or the latest result in the treatment phase. Linear regression was used to estimate the mean change. The covariates were study arm and the gender and CD4 stratification factors. |
| Secondary | Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure | Measured from study entry through Week 48 | 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. |
| Secondary | Rate of Change in Odds of Oral CMV DNA Detection | Measured at Baseline and Weeks 8, 46, 48, 52 and 60 | When the number of detection outcomes was sufficient, binary repeated oral CMV DNA detection (yes/no) was modeled with generalized estimating equations (GEE) to estimate the weekly rate of change (slope). The covariates were study arm and the gender and CD4 stratification factors, as well as a three-level period effect (early treatment phase \[through Week 8\], late treatment phase, post-treatment phase) and its interaction with the study arm. Due to the small sample size and small number of detectable CMV DNA results, the GEE model was not able to provide estimates. Cross-sectional CMV DNA detection summaries have been provided instead. |
| Secondary | Rate of Change in Odds of Genital CMV DNA Detection | Measured at Baseline and Weeks 8, 46, 48, 52 and 60 | When the number of detection outcomes was sufficient, binary repeated genital CMV DNA detection (yes/no) was modeled with generalized estimating equations (GEE) to estimate the weekly rate of change (slope). The covariates were study arm and the gender and CD4 stratification factors, as well as a three-level period effect (early treatment phase \[through Week 8\], late treatment phase, post-treatment phase) and its interaction with the study arm. The model estimates do not reflect the odds of detection, but rather, the change in the odds of detection per week on the multiplicative scale. |
| Secondary | Rate of Change in Odds of Rectal CMV DNA Detection | Measured at Baseline and Weeks 8, 48 and 60 | When the number of detection outcomes was sufficient, binary repeated rectal CMV DNA detection (yes/no) was modeled with generalized estimating equations (GEE) to estimate the weekly rate of change (slope). The covariates were study arm and the gender and CD4 stratification factors, as well as a three-level period effect (early treatment phase \[through Week 8\], late treatment phase, post-treatment phase) and its interaction with the study arm. Due to the small sample size and small number of detectable CMV DNA results, the GEE model was not able to provide estimates. Cross-sectional CMV DNA detection summaries have been provided instead. |
| Secondary | Rate of Change in Odds of Plasma CMV DNA Detection | Measured at Baseline and Weeks 8, 46, 48, 52 and 60 | When the number of detection outcomes was sufficient, binary repeated plasma CMV DNA detection (yes/no) was modeled with generalized estimating equations (GEE) to estimate the weekly rate of change (slope). The covariates were study arm and the gender and CD4 stratification factors, as well as a three-level period effect (early treatment phase \[through Week 8\], late treatment phase, post-treatment phase) and its interaction with the study arm. Due to the small sample size and small number of detectable CMV DNA results, the GEE model was not able to provide estimates. Cross-sectional CMV DNA detection summaries have been provided instead. |
| Secondary | Rate of Change in sCD163 | Measured at Baseline and Weeks 8, 24, 46, 48, 52 and 60 | Repeated, continuous sCD163 was modeled with generalized estimating equations (GEE) to estimate the weekly rate of change (slope). The covariates were study arm and the gender and CD4 stratification factors, as well as a three-level period effect (early treatment phase \[through Week 8\], late treatment phase, post-treatment phase) and its interaction with the study arm. |
| Secondary | Rate of Change in sTNFRII | Measured at Baseline and Weeks 8, 24, 46, 48, 52 and 60 | Repeated, continuous sTNFRII was modeled with generalized estimating equations (GEE) to estimate the weekly rate of change (slope). The covariates were study arm and the gender and CD4 stratification factors, as well as a three-level period effect (early treatment phase \[through Week 8\], late treatment phase, post-treatment phase) and its interaction with the study arm. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change (Absolute) in sTNFRII | Measured at Baseline and Weeks 46 and 48 | Per-protocol population: All mITT participants who did not prematurely discontinue study product prior to Week 8, had self-reported adherence \>50% (letermovir arm only) and did not have a confirmed HIV-1 virologic failure during the treatment phase. | log10 pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure | Measured from study entry through Week 48 | Modified intent to treat population: all eligible, randomized participants excluding letermovir arm participants who did not initiate study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Change in Odds of Oral CMV DNA Detection | Measured at Baseline and Weeks 8, 46, 48, 52 and 60 | Per-protocol population: All mITT participants who did not prematurely discontinue study product prior to Week 8, had self-reported adherence \>50% (letermovir arm only) and did not have a confirmed HIV-1 virologic failure during the treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Change in Odds of Genital CMV DNA Detection | Measured at Baseline and Weeks 8, 46, 48, 52 and 60 | Per-protocol population: All mITT participants who did not prematurely discontinue study product prior to Week 8, had self-reported adherence \>50% (letermovir arm only) and did not have a confirmed HIV-1 virologic failure during the treatment phase. | change in odds of detection per week | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Change in Odds of Rectal CMV DNA Detection | Measured at Baseline and Weeks 8, 48 and 60 | Per-protocol population: All mITT participants who did not prematurely discontinue study product prior to Week 8, had self-reported adherence \>50% (letermovir arm only) and did not have a confirmed HIV-1 virologic failure during the treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Change in Odds of Plasma CMV DNA Detection | Measured at Baseline and Weeks 8, 46, 48, 52 and 60 | Per-protocol population: All mITT participants who did not prematurely discontinue study product prior to Week 8, had self-reported adherence \>50% (letermovir arm only) and did not have a confirmed HIV-1 virologic failure during the treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Change in sCD163 | Measured at Baseline and Weeks 8, 24, 46, 48, 52 and 60 | Per-protocol population: All mITT participants who did not prematurely discontinue study product prior to Week 8, had self-reported adherence \>50% (letermovir arm only) and did not have a confirmed HIV-1 virologic failure during the treatment phase. | log10 ng/mL/week | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Change in sTNFRII | Measured at Baseline and Weeks 8, 24, 46, 48, 52 and 60 | Per-protocol population: All mITT participants who did not prematurely discontinue study product prior to Week 8, had self-reported adherence \>50% (letermovir arm only) and did not have a confirmed HIV-1 virologic failure during the treatment phase. | log10 pg/mL/week | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change (Absolute) in sTNFRII | Letermovir | -0.028 | 95% Confidence Interval -0.064 to 0.008 | log10 pg/mL | |
| Change (Absolute) in sTNFRII | No Anti-CMV Treatment | 0.003 | 95% Confidence Interval -0.029 to 0.036 | log10 pg/mL | |
| Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure | Letermovir | 5 | Participants | ||
| Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure | No Anti-CMV Treatment | 2 | Participants | ||
| Rate of Change in Odds of Oral CMV DNA Detection | Letermovir | Baseline / Detected | 2 | Participants | |
| Rate of Change in Odds of Oral CMV DNA Detection | No Anti-CMV Treatment | Baseline / Detected | 1 | Participants | |
| Rate of Change in Odds of Oral CMV DNA Detection | Letermovir | Baseline / Not detected | 15 | Participants | |
| Rate of Change in Odds of Oral CMV DNA Detection | No Anti-CMV Treatment | Baseline / Not detected | 20 | Participants | |
| Rate of Change in Odds of Oral CMV DNA Detection | Letermovir | Baseline / No result | 0 | Participants | |
| Rate of Change in Odds of Oral CMV DNA Detection | No Anti-CMV Treatment | Baseline / No result | 1 | Participants |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Letermovir | 21 | |
| Overall Study | STARTED | No Anti-CMV Treatment | 23 | |
| Overall Study | COMPLETED | Letermovir | 10 | |
| Overall Study | COMPLETED | No Anti-CMV Treatment | 11 | |
| Overall Study | NOT COMPLETED | Letermovir | 11 | |
| Overall Study | NOT COMPLETED | No Anti-CMV Treatment | 12 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Letermovir | 3 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | No Anti-CMV Treatment | 0 | 22 | |
| other | Fatigue | General disorders | Letermovir | 1 | 19 | |
| other | Fatigue | General disorders | No Anti-CMV Treatment | 0 | 22 | |
| other | COVID-19 | Infections and infestations | Letermovir | 3 | 19 | |
| other | COVID-19 | Infections and infestations | No Anti-CMV Treatment | 4 | 22 | |
| other | Soft tissue injury | Injury, poisoning and procedural complications | Letermovir | 1 | 19 | |
| other | Soft tissue injury | Injury, poisoning and procedural complications | No Anti-CMV Treatment | 0 | 22 | |
| other | CD4 lymphocytes decreased | Investigations | Letermovir | 1 | 19 | |
| other | CD4 lymphocytes decreased | Investigations | No Anti-CMV Treatment | 1 | 22 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Letermovir | 0 | 19 |
| Total, all-cause mortality | No Anti-CMV Treatment | 0 | 22 |
| Total, other adverse events | Letermovir | 9 | 19 |
| Total, other adverse events | No Anti-CMV Treatment | 5 | 22 |
| Total, serious adverse events | Letermovir | 1 | 19 |
| Total, serious adverse events | No Anti-CMV Treatment | 1 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Letermovir vs No Anti-CMV Treatment: Occurrence of Grade ≥3 AEs or Confirmed HIV-1 Virologic Failure | Trial comparisons |
| Letermovir vs No Anti-CMV Treatment: deaths from any cause | Trial comparisons |
| Letermovir vs No Anti-CMV Treatment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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