Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT01910402 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 499 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\<vs. \>100,000 c/mL) and CD4+ cell count (=\<350 cells per millimeter cube (cells/mm\^3) or \>350 cells/mm\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of
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 |
What the finished NCT01910402 record still lists
NCT01910402 is an interventional study that assigns participants to a tested intervention. The registered 499 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.
NCT01910402 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01910402's enrollment target sits among peer trials
499 775th of 2000 higher than 1,226 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04137900 · 499 participants · Phase 1
Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies
- NCT06733480 · 499 participants · NA
Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue
- NCT00001230 · 500 participants
Host Response to Infection and Treatment in Filarial Diseases
- NCT00001529 · 500 participants
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI