N/A
Completed N=2,446
Prospective Observational Epidemiologic Study of Maraviroc's Safety
Source: ClinicalTrials.gov NCT00665561 ↗Enrolled (actual)
2,446
Serious AEs
32.2%
Results posted
Apr 2020
Primary outcomePrimary: Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections — 22.28; 41.77 events per 1000 participant-years
Summary
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections |
22.28; 41.77 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis |
0.38; 0.46 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) |
12.87; 13.69; 2.31; 3.71; 10.56; 9.98 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Liver Failure |
2.50; 2.55 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' |
4.80; 5.34 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' |
8.26; 7.43 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis |
0.77; 0.70 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause |
0.77; 1.16 | — |
| PRIMARY Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause |
14.41; 18.33 | — |
| PRIMARY Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections |
22.36; 28.70 | — |
| PRIMARY Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) |
12.49; 13.54; 2.31; 3.31; 9.87; 9.86 | — |
| PRIMARY Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' |
2.08; 3.37 | — |
| PRIMARY Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' |
5.65; 5.99 | — |
| PRIMARY Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause |
14.39; 15.64 | — |
| PRIMARY Percentage of Participants With All-Cause Mortality |
5.7; 7.0 | 0.6225 |
Eligibility Criteria
Inclusion Criteria
- Treatment experienced, HIV-1 infected patients
- 18 years or older
- Receive an approved assay for determination of HIV-1 tropism
Exclusion Criteria
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc
Data sourced from ClinicalTrials.gov (NCT00665561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.