Trial · NCT00665561
Prospective Observational Epidemiologic Study of Maraviroc's Safety
NCT00665561, Completed, ViiV Healthcare; results first posted 2020-04-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Prospective Observational Epidemiologic Study of Maraviroc's Safety. Trials, record NCT00665561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00665561
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Observational Epidemiologic Study of Maraviroc's Safety
- NCT number
- NCT00665561
- Status
- Completed
- Enrollment
- 2,500 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Maraviroc along with an optimized background antiretroviral drug regimen, Optimized background antiretroviral drug regimen without maraviroc
- First posted
- 2008-04-24
- Last updated
- 2022-10-18
- Other registries' IDs
- eudract:2007-006148-24
- Results first posted
- 2020-04-07
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI). |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Liver Failure | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported. |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported. |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Primary | Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | Up to 5 years following enrollment | Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. |
| Primary | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections | Up to 5 years following enrollment | Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Liver Failure | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
| PRIMARY | Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections | Up to 5 years following enrollment | Safety analysis set included all participants who were enrolled in the study. | events per 1000 participant-years | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections | Maraviroc Exposed | 22.28 | 95% Confidence Interval 18.57 to 26.73 | events per 1000 participant-years | |
| Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections | Maraviroc Unexposed | 41.77 | 95% Confidence Interval 36.09 to 48.34 | events per 1000 participant-years | |
| Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis | Maraviroc Exposed | 0.38 | 95% Confidence Interval 0.10 to 1.54 | events per 1000 participant-years | |
| Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis | Maraviroc Unexposed | 0.46 | 95% Confidence Interval 0.12 to 1.86 | events per 1000 participant-years | |
| Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Maraviroc Exposed | All Malignancies | 12.87 | 95% Confidence Interval 10.13 to 16.35 | events per 1000 participant-years |
| Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Maraviroc Unexposed | All Malignancies | 13.69 | 95% Confidence Interval 10.61 to 17.67 | events per 1000 participant-years |
| Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Maraviroc Exposed | AIDS defining Malignancies | 2.31 | 95% Confidence Interval 1.31 to 4.06 | events per 1000 participant-years |
| Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Maraviroc Unexposed | AIDS defining Malignancies | 3.71 | 95% Confidence Interval 2.27 to 6.06 | events per 1000 participant-years |
| Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Maraviroc Exposed | Non-AIDS defining Malignancies | 10.56 | 95% Confidence Interval 8.11 to 13.76 | events per 1000 participant-years |
| Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) | Maraviroc Unexposed | Non-AIDS defining Malignancies | 9.98 | 95% Confidence Interval 7.40 to 13.45 | events per 1000 participant-years |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Maraviroc Exposed | 1,316 | |
| Overall Study | STARTED | Maraviroc Unexposed | 1,130 | |
| Overall Study | COMPLETED | Maraviroc Exposed | 814 | |
| Overall Study | COMPLETED | Maraviroc Unexposed | 596 | |
| Overall Study | NOT COMPLETED | Maraviroc Exposed | 502 | |
| Overall Study | NOT COMPLETED | Maraviroc Unexposed | 534 |
Source ClinicalTrials.gov
Adverse events1,494
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 | Maraviroc Exposed | 32 | 1,316 | |
| other | Diarrhoea | Gastrointestinal disorders | Maraviroc Unexposed | 14 | 1,130 | |
| other | Nausea | Gastrointestinal disorders | Maraviroc Exposed | 18 | 1,316 | |
| other | Nausea | Gastrointestinal disorders | Maraviroc Unexposed | 5 | 1,130 | |
| other | Fatigue | General disorders | Maraviroc Exposed | 15 | 1,316 | |
| other | Fatigue | General disorders | Maraviroc Unexposed | 6 | 1,130 | |
| other | Bronchitis | Infections and infestations | Maraviroc Exposed | 18 | 1,316 | |
| other | Bronchitis | Infections and infestations | Maraviroc Unexposed | 5 | 1,130 | |
| other | Nasopharyngitis | Infections and infestations | Maraviroc Exposed | 16 | 1,316 | |
| other | Nasopharyngitis | Infections and infestations | Maraviroc Unexposed | 0 | 1,130 |
1 to 10 of 1,494Source ClinicalTrials.gov
See all 1,494 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maraviroc Exposed | 75 | 1,316 |
| Total, all-cause mortality | Maraviroc Unexposed | 79 | 1,130 |
| Total, other adverse events | Maraviroc Exposed | 111 | 1,316 |
| Total, other adverse events | Maraviroc Unexposed | 34 | 1,130 |
| Total, serious adverse events | Maraviroc Exposed | 435 | 1,316 |
| Total, serious adverse events | Maraviroc Unexposed | 352 | 1,130 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Maraviroc Exposed vs Maraviroc Unexposed: deaths from any cause | Trial comparisons |
| Maraviroc Exposed vs Maraviroc Unexposed: 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00665561
GET https://conductscience.org/api/trials/v1/NCT00665561/results?page=2