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NCT01910402 · ClinicalTrials.gov registry record · Phase 3
A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 499
- Enrollment target
NCT01910402 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 499 participants.
The verdict
NCT01910402, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 499 participants
- Enrollment target
Study Summary
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)
Interventions
- DRUG Ritonavir
- DRUG Atazanavir
- DRUG Dolutegravir/abacavir/lamivudine FDC
- DRUG Tenofovir/emtricitabine FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2013-08-22 |
| Est. Completion | 2022-08-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01910402
The ClinicalTrials.gov registry entry for NCT01910402 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 499 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 4 interventions - of which Ritonavir is the first listed.
NCT01910402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01910402 about?
NCT01910402 is a clinical study titled "A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)". This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve w...
What is the current status of trial NCT01910402?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 499 participants. The study started on 2013-08-22. Estimated completion is 2022-08-18.
What interventions are being tested in trial NCT01910402?
The interventions under investigation include: Ritonavir (DRUG), Atazanavir (DRUG), Dolutegravir/abacavir/lamivudine FDC (DRUG), Tenofovir/emtricitabine FDC (DRUG).
Who is sponsoring clinical trial NCT01910402?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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