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NCT00665561 · ClinicalTrials.gov registry record
Prospective Observational Epidemiologic Study of Maraviroc's Safety
A clinical trial, sponsored by ViiV Healthcare.
- Completed
- Registry status
- 2,500
- Enrollment target
NCT00665561: Completed study, sponsored by ViiV Healthcare.
NCT00665561 is a clinical trial that has completed, run by ViiV Healthcare. The registered enrollment target is 2,500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665561 has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- 2,500 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Maraviroc along with an optimized background antiretroviral drug regimen
- DRUG Optimized background antiretroviral drug regimen without maraviroc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2008-03-31 |
| Est. Completion | 2019-02-14 |
What the finished NCT00665561 record still lists
NCT00665561 is an observational study that tracks outcomes without assigning an intervention. Its 2,500 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Maraviroc along with an optimized background antiretroviral drug regimen is the first listed.
NCT00665561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00665561 about?
NCT00665561 is a clinical study titled "Prospective Observational Epidemiologic Study of Maraviroc's Safety". 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.
What is the current status of trial NCT00665561?
This trial is currently completed. The enrollment target is 2,500 participants. The study started on 2008-03-31. Estimated completion is 2019-02-14.
What interventions are being tested in trial NCT00665561?
The interventions under investigation include: Maraviroc along with an optimized background antiretroviral drug regimen (DRUG), Optimized background antiretroviral drug regimen without maraviroc (DRUG).
Who is sponsoring clinical trial NCT00665561?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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