Trial · NCT03048422
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
NCT03048422, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2021-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants. Trials, record NCT03048422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03048422
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
- NCT number
- NCT03048422
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 643 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- Dolutegravir, Emtricitabine/tenofovir alafenamide, Emtricitabine/tenofovir disoproxil fumarate, Efavirenz/emtricitabine/tenofovir disoproxil fumarate
- First posted
- 2017-02-09
- Last updated
- 2026-07-31
- Results first posted
- 2021-11-10
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | Delivery | 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) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication. |
| Primary | Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome | Delivery | Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile by INTERGROWTH 21st Standards) |
| Primary | Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event | From randomization up to 74 weeks | The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks. |
| Primary | Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event | From birth through Week 50 postpartum | The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. |
| Secondary | Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory | Delivery | Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory |
| Secondary | Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum | 50 weeks postpartum | Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories |
| Secondary | Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery | Randomization to delivery | Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories |
| Secondary | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm | Delivery | Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories |
| Secondary | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm | 50 weeks postpartum | Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories |
| Secondary | Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome | Delivery | Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile per INTERGROWTH 21st Standards) |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | Delivery | Women who had plasma HIV-1 RNA viral load data available at delivery | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome | Delivery | Mother-infant pairs with pregnancy outcome evaluated on study. | percentage of mother-infant pairs | NUMBER |
| PRIMARY | Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event | From randomization up to 74 weeks | Enrolled women. | Cumulative probability per 100 persons | NUMBER |
| PRIMARY | Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event | From birth through Week 50 postpartum | Live born infants | Cumulative probability per 100 persons | NUMBER |
| SECONDARY | Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory | Delivery | Women with viral load data available from central laboratory | percentage of participants | NUMBER |
| SECONDARY | Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum | 50 weeks postpartum | Women with viral load data available. | percentage of participants | NUMBER |
| SECONDARY | Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery | Randomization to delivery | Women with viral load data available. | weeks | MEAN |
| SECONDARY | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm | Delivery | Enrolled women | percentage of participants | NUMBER |
| SECONDARY | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm | 50 weeks postpartum | Enrolled women | percentage of participants | NUMBER |
| SECONDARY | Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome | Delivery | Mother-infant pairs with pregnancy outcome evaluated on study | percentage of mother-infant pairs | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Intention-to-Treat Analysis | 97.5 | Percentage of participants | |
| Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | Arm 3: Maternal EFV/FTC/TDF | Intention-to-Treat Analysis | 91.0 | Percentage of participants | |
| Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Per-Protocol Analysis | 97.5 | Percentage of participants | |
| Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | Arm 3: Maternal EFV/FTC/TDF | Per-Protocol Analysis | 91.4 | Percentage of participants | |
| Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome | Arm 1: Maternal DTG+FTC/TAF | 24.1 | percentage of mother-infant pairs | ||
| Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome | Arm 2: Maternal DTG+FTC/TDF | 32.9 | percentage of mother-infant pairs | ||
| Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome | Arm 3: Maternal EFV/FTC/TDF | 32.7 | percentage of mother-infant pairs | ||
| Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event | Arm 1: Maternal DTG+FTC/TAF | 25.1 | Cumulative probability per 100 persons | ||
| Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event | Arm 2: Maternal DTG+FTC/TDF | 30.8 | Cumulative probability per 100 persons | ||
| Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event | Arm 3: Maternal EFV/FTC/TDF | 27.9 | Cumulative probability per 100 persons |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Maternal DTG+FTC/TAF | 217 | |
| Overall Study | STARTED | Arm 2: Maternal DTG+FTC/TDF | 215 | |
| Overall Study | STARTED | Arm 3: Maternal EFV/FTC/TDF | 211 | |
| Overall Study | COMPLETED | Arm 1: Maternal DTG+FTC/TAF | 200 | |
| Overall Study | COMPLETED | Arm 2: Maternal DTG+FTC/TDF | 205 | |
| Overall Study | COMPLETED | Arm 3: Maternal EFV/FTC/TDF | 202 | |
| Overall Study | NOT COMPLETED | Arm 1: Maternal DTG+FTC/TAF | 17 | |
| Overall Study | NOT COMPLETED | Arm 2: Maternal DTG+FTC/TDF | 10 | |
| Overall Study | NOT COMPLETED | Arm 3: Maternal EFV/FTC/TDF | 9 |
Source ClinicalTrials.gov
Adverse events1,668
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm 1: Maternal DTG+FTC/TAF | 0 | 217 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 2: Maternal DTG+FTC/TDF | 1 | 215 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 3: Maternal EFV/FTC/TDF | 3 | 211 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 1 Infants | 0 | 208 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 2 Infants | 0 | 202 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 3 Infants | 1 | 207 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Arm 1: Maternal DTG+FTC/TAF | 0 | 217 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Arm 2: Maternal DTG+FTC/TDF | 0 | 215 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Arm 3: Maternal EFV/FTC/TDF | 1 | 211 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Arm 1 Infants | 0 | 208 |
1 to 10 of 1,668Source ClinicalTrials.gov
See all 1,668 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Maternal DTG+FTC/TAF | 1 | 217 |
| Total, all-cause mortality | Arm 2: Maternal DTG+FTC/TDF | 0 | 215 |
| Total, all-cause mortality | Arm 3: Maternal EFV/FTC/TDF | 0 | 211 |
| Total, all-cause mortality | Arm 1 Infants | 2 | 208 |
| Total, all-cause mortality | Arm 2 Infants | 4 | 202 |
| Total, all-cause mortality | Arm 3 Infants | 14 | 207 |
| Total, other adverse events | Arm 1: Maternal DTG+FTC/TAF | 189 | 217 |
| Total, other adverse events | Arm 2: Maternal DTG+FTC/TDF | 198 | 215 |
| Total, other adverse events | Arm 3: Maternal EFV/FTC/TDF | 143 | 211 |
| Total, other adverse events | Arm 1 Infants | 34 | 208 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03048422
GET https://conductscience.org/api/trials/v1/NCT03048422/registered?page=2