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NCT01345630 · ClinicalTrials.gov registry record · Phase 3
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
A Phase 3 study, sponsored by ViiV Healthcare.
- Terminated
- Registry status
- Phase 3
- Development phase
- 813
- Enrollment target
NCT01345630: Clinical Trial Phase 3 study, sponsored by ViiV Healthcare.
NCT01345630 is a Phase 3 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 813 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01345630, a Phase 3 study, was terminated before completion, sponsored by ViiV Healthcare.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 813 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.
Primary Outcome
The proportion of participants who achieved HIV-1 RNA \<50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a
Interventions
- DRUG Maraviroc
- DRUG Emtricitabine/tenofovir
- DRUG darunavir/ritonavir 800/100 mg
- DRUG placebo for emtricitabine/tenofovir
- DRUG placebo for maraviroc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
Why NCT01345630 stopped before completion
NCT01345630 is an interventional study that assigns participants to a tested intervention. The registered 813 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Maraviroc is the first listed.
NCT01345630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01345630 about?
NCT01345630 is a clinical study titled "Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1". The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.
What is the current status of trial NCT01345630?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 813 participants. The study started on 2011-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01345630?
The interventions under investigation include: Maraviroc (DRUG), Emtricitabine/tenofovir (DRUG), darunavir/ritonavir 800/100 mg (DRUG), placebo for emtricitabine/tenofovir (DRUG), placebo for maraviroc (DRUG).
Who is sponsoring clinical trial NCT01345630?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01345630's enrollment target sits among peer trials
813 407th of 2000 higher than 1,593 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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