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NCT01328041 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 183
- Enrollment target
NCT01328041 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 183 participants.
The verdict
NCT01328041, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 183 participants
- Enrollment target
Study Summary
The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.
Interventions
- DRUG dolutegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01328041
The ClinicalTrials.gov registry entry for NCT01328041 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which dolutegravir is the first listed.
NCT01328041 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01328041 about?
NCT01328041 is a clinical study titled "A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.". The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg...
What is the current status of trial NCT01328041?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 183 participants. The study started on 2011-05. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01328041?
The interventions under investigation include: dolutegravir (DRUG).
Who is sponsoring clinical trial NCT01328041?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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