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NCT03048422 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
NCT03048422: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03048422 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 643 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03048422, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 643 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.
Primary Outcome
Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) bef
Interventions
- DRUG Dolutegravir
- DRUG Emtricitabine/tenofovir disoproxil fumarate
- DRUG Emtricitabine/tenofovir alafenamide
- DRUG Efavirenz/emtricitabine/tenofovir disoproxil fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2018-01-19 |
| Est. Completion | 2020-10-03 |
| Phase | Phase 3 |
What the finished NCT03048422 record still lists
NCT03048422 is an interventional study that assigns participants to a tested intervention. The registered 643 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 (17% lower).
The record links to 0 conditions, and to 4 interventions - of which Dolutegravir is the first listed.
NCT03048422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03048422 about?
NCT03048422 is a clinical study titled "Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants". The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregna...
What is the current status of trial NCT03048422?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2018-01-19. Estimated completion is 2020-10-03.
What interventions are being tested in trial NCT03048422?
The interventions under investigation include: Dolutegravir (DRUG), Emtricitabine/tenofovir disoproxil fumarate (DRUG), Emtricitabine/tenofovir alafenamide (DRUG), Efavirenz/emtricitabine/tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT03048422?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03048422's enrollment target sits among peer trials
643 573rd of 2000 higher than 1,427 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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