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NCT00993148 · ClinicalTrials.gov registry record · Phase 2
Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
A Phase 2 study of HIV Infections and HIV-1-infection, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 5
- Study locations
NCT00993148: Completed Phase 2 study of HIV Infections and HIV-1-infection, sponsored by Northwestern University.
NCT00993148 is a Phase 2 study of HIV Infections and HIV-1-infection that has completed, run by Northwestern University. The registered enrollment target is 25 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00993148, a Phase 2 study of HIV Infections and HIV-1-infection, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 5
- Study locations
Study Summary
The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.
Primary Outcome
Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL
Conditions Studied
Interventions
- DRUG ritonavir
- DRUG darunavir
- DRUG maraviroc
Study Locations (5)
Illinois
- Northwestern University - Chicago
- CORECenter - Chicago
California
- Quest Clinical Research - San Francisco
Florida
- University of Miami - Miami
Nebraska
- University of Nebraska - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT00993148 record still lists
NCT00993148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which ritonavir is the first listed.
NCT00993148 lists 5 locations in 4 states (Illinois, California, Florida).
Frequently Asked Questions
What is clinical trial NCT00993148 about?
NCT00993148 is a clinical study titled "Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1". The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tro...
What is the current status of trial NCT00993148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2010-05. Estimated completion is 2013-04.
What conditions does trial NCT00993148 study?
This clinical trial studies the following conditions: HIV Infections, HIV-1-infection.
What interventions are being tested in trial NCT00993148?
The interventions under investigation include: ritonavir (DRUG), darunavir (DRUG), maraviroc (DRUG).
Who is sponsoring clinical trial NCT00993148?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00993148 being conducted?
This trial has 5 study locations across California, Florida, Illinois, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00993148's enrollment target sits among peer trials
25 461st of 542 higher than 74 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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