Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiret… (NCT03048422) | Clinical Trial Compass
CompletedPhase 3
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
United States, Botswana, Brazil643 participantsStarted 2018-01-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Mother is able to provide written informed consent for her and her infant's participation in this study
* Mother has confirmed HIV-1 infection based on documented testing of two samples collected at different time points:
* Sample #1 may be tested using any of the following:
* Two rapid antibody tests from different manufacturers or based on different principles and epitopes
* One enzyme immunoassay (EIA) OR Western blot OR immunofluorescence assay OR chemiluminescence assay
* One HIV DNA polymerase chain reaction (PCR)
* One quantitative HIV RNA PCR (above the limit of detection of the assay)
* One qualitative HIV RNA PCR
* One total HIV nucleic acid test
* Sample #2 may be tested using any of the following:
* One rapid antibody test. If this option is used in combination with two rapid tests for Sample #1, at least one of the three rapid tests must be FDA-approved and the third rapid test must be from a third manufacturer or based on a third principle or epitope.
* One EIA OR Western blot OR immunofluorescence assay OR chemiluminescence assay
* One HIV DNA PCR
* One quantitative HIV RNA PCR (above the limit of detection of the assay)
* One qualitative HIV RNA PCR
* One total HIV nucleic acid test.
* See the protocol for more information on this inclusion criterion.
* At screening, mother is ART-naive, defined as having not received prior antiretroviral therapy other than ARVs received during prior pregnancies or prior pe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
Timeframe: Delivery
2
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome
Timeframe: Delivery
3
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
Timeframe: From randomization up to 74 weeks
4
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
Timeframe: From birth through Week 50 postpartum
Trial details
NCT IDNCT03048422
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)