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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03048422
The ClinicalTrials.gov registry entry for NCT03048422 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 643 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dolutegravir is the first listed.
NCT03048422 reports 0 study locations.
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.
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