Trial · NCT01061151
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
NCT01061151, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2018-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries. Trials, record NCT01061151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01061151
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
- NCT number
- NCT01061151
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,747 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail, Lamivudine-Zidovudine (3TC-ZDV), Lopinavir-ritonavir (LPV-RTV), Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]), Nevirapine (NVP): Infant short-course, Nevirapine (NVP): Infant extended, No Intervention, Discontinue triple ARVs, Continue triple ARVs
- First posted
- 2010-02-02
- Last updated
- 2022-02-11
- Results first posted
- 2018-02-09
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Antepartum Component: Number of Confirmed Infant HIV Infections | Measured at birth or Week 1 study visit | Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point |
| Primary | Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Measured through the Week 1 postpartum study visit | These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). |
| Primary | Antepartum Component: Number of Mothers With Obstetrical Complications | Measured through the Week 1 postpartum study visit | Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as "Pregnancy, puerperium and perinatal conditions", except if the condition was the death of the fetus: "Abortions not specified as induced or spontaneous", "Abortions spontaneous", or "Stillbirth and foetal death." |
| Primary | Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) | Measured at birth | Composite outcome |
| Primary | Postpartum Component: Incidence of Confirmed Infant HIV Infection | Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first | Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 \[Day 6-14\] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. |
| Primary | Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first | These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). |
| Primary | Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group. |
| Secondary | Antepartum Component: Number of Infant HIV Infections | Measured at the birth (<= 3 days postpartum) visit | Detected by HIV NAT positivity |
| Secondary | Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) | Measured from birth through 104 weeks of age | For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. |
| Secondary | Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery | Measured at the time of delivery | Analysis used the principle of intent to treat. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Antepartum Component: Number of Confirmed Infant HIV Infections | Measured at birth or Week 1 study visit | Analysis includes data from periods 1 and 2. Analysis is among the live births with HIV test results summarized for the maternal-infant set (the worst outcome summarized for cases of multiple births). Analysis used the principle of intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Measured through the Week 1 postpartum study visit | Mothers with no safety data available after baseline were not included. Analysis used the principle of intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antepartum Component: Number of Mothers With Obstetrical Complications | Measured through the Week 1 postpartum study visit | Mothers who do not have any obstetrical complications information available after study entry are not included. Analysis used the principle of intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) | Measured at birth | Includes mothers with confirmed infant birth outcome as live birth, stillbirth, or spontaneous abortion and outcome assessments. Multiple gestation pregnancies (twins and triplets) were summarized at the unique mother level. Analysis used the principle of intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Postpartum Component: Incidence of Confirmed Infant HIV Infection | Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first | All Mother-Infant (M-I) pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 35 M-I pairs with no post-randomization HIV test results were included and censored at the date of randomization in the analyses. Analyses were intent to treat. | New cases per 100 person-years | NUMBER |
| PRIMARY | Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first | All mothers were included in the analyses. 15 mothers with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat. | New cases per 100 person-years | NUMBER |
| PRIMARY | Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle. | New cases per 100 person-years | NUMBER |
| SECONDARY | Antepartum Component: Number of Infant HIV Infections | Measured at the birth (<= 3 days postpartum) visit | Analysis is among the live births with HIV test results summarized in the maternal-infant set (the worst outcome summarized for multiple births to the same mother). Analysis used the principle of intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) | Measured from birth through 104 weeks of age | Infants in the antepartum component not excluded from analysis; only one infant was included per pregnancy, the one with the earliest failure time. The Periods 1\&2 group is infants born to mothers randomized in Arms A and B throughout the PROMISE study (both protocol versions). The period 2 group includes infants born to mothers randomized during the last protocol version only. Since Arm C was only available to all under the last protocol version, this enables unbiased comparison with Arm C. | Proportional probability | NUMBER |
| SECONDARY | Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery | Measured at the time of delivery | Analysis includes only mothers with HIV RNA data at delivery. Analysis used the principle of intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Antepartum Component: Number of Confirmed Infant HIV Infections | Antepartum Arm A | 25 | Participants | ||
| Antepartum Component: Number of Confirmed Infant HIV Infections | Antepartum Arm B | 7 | Participants | ||
| Antepartum Component: Number of Confirmed Infant HIV Infections | Antepartum Arm C | 2 | Participants | ||
| Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Antepartum Arm A | Periods 1 and 2 | 261 | Participants | |
| Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Antepartum Arm B | Periods 1 and 2 | 318 | Participants | |
| Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Antepartum Arm A | Period 2 | 59 | Participants | |
| Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Antepartum Arm B | Period 2 | 61 | Participants | |
| Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events | Antepartum Arm C | Period 2 | 60 | Participants | |
| Antepartum Component: Number of Mothers With Obstetrical Complications | Antepartum Arm A | Periods 1 and 2 | 89 | Participants | |
| Antepartum Component: Number of Mothers With Obstetrical Complications | Antepartum Arm B | Periods 1 and 2 | 75 | Participants |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Protocol Version 2.0: 04/2011-09/2012 | STARTED | Antepartum Arm A | 855 | |
| Protocol Version 2.0: 04/2011-09/2012 | STARTED | Antepartum Arm B | 861 | |
| Protocol Version 2.0: 04/2011-09/2012 | STARTED | Antepartum Arm C | 25 | |
| Protocol Version 2.0: 04/2011-09/2012 | STARTED | Late Presenters | 129 | |
| Protocol Version 2.0: 04/2011-09/2012 | Mothers That Met All Inclusion Criteria | Antepartum Arm A | 853 | |
| Protocol Version 2.0: 04/2011-09/2012 | Mothers That Met All Inclusion Criteria | Antepartum Arm B | 861 | |
| Protocol Version 2.0: 04/2011-09/2012 | Mothers That Met All Inclusion Criteria | Antepartum Arm C | 24 | |
| Protocol Version 2.0: 04/2011-09/2012 | Mothers That Met All Inclusion Criteria | Late Presenters | 129 | |
| Protocol Version 2.0: 04/2011-09/2012 | COMPLETED | Antepartum Arm A | 623 | |
| Protocol Version 2.0: 04/2011-09/2012 | COMPLETED | Antepartum Arm B | 620 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events2,840
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Mother, (AP) ZDV+sdNVP+TRV Tail | 34 | 1,547 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV) | 33 | 1,545 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV) | 3 | 445 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Mother, LP | 10 | 204 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Infant, (Mother Received ZDV+sdNVP+TRV Tail) | 96 | 1,500 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV)) | 81 | 1,478 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV)) | 6 | 429 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Infant, LP | 18 | 204 | |
| other | Congenital umbilical hernia | Congenital, familial and genetic disorders | Mother, (AP) ZDV+sdNVP+TRV Tail | 0 | 1,547 | |
| other | Congenital umbilical hernia | Congenital, familial and genetic disorders | Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV) | 0 | 1,545 |
1 to 10 of 2,840Source ClinicalTrials.gov
See all 2,840 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mother, (AP) ZDV+sdNVP+TRV Tail | 9 | 1,547 |
| Total, all-cause mortality | Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV) | 14 | 1,545 |
| Total, all-cause mortality | Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV) | 2 | 445 |
| Total, all-cause mortality | Mother, LP | 3 | 204 |
| Total, all-cause mortality | Infant, (Mother Received ZDV+sdNVP+TRV Tail) | 59 | 1,500 |
| Total, all-cause mortality | Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV)) | 46 | 1,478 |
| Total, all-cause mortality | Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV)) | 27 | 429 |
| Total, all-cause mortality | Infant, LP | 5 | 204 |
| Total, other adverse events | Mother, (AP) ZDV+sdNVP+TRV Tail | 1,413 | 1,547 |
| Total, other adverse events | Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV) | 1,414 | 1,545 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers12
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/NCT01061151
GET https://conductscience.org/api/trials/v1/NCT01061151/registered?page=2