N/A N=2,446

Prospective Observational Epidemiologic Study of Maraviroc's Safety

Human Immunodeficiency Virus

Bottom Line

View on ClinicalTrials.gov: NCT00665561 ↗

Enrolled (actual)

2,446

Serious AEs

32.2%

Results posted

Apr 2020

Primary outcome: 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 events per 1000 participant-years

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Maraviroc along with an optimized background antiretroviral drug regimen (Drug); Optimized background antiretroviral drug regimen without maraviroc (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ViiV Healthcare
Primary completion: Feb 2019

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

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.

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

View full record on ClinicalTrials.gov →

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.