Trial · NCT01061151
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| 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. |
| Secondary | Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery | Measured through 24 months post-delivery | Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. |
| Secondary | Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery | Measured at 12 and 24 months post-delivery | Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair) |
| Secondary | Maternal Health Component: Incidence of Death | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over. |
| Secondary | Maternal Health Component: Incidence of AIDS-defining Illness | 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 listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group. |
| Secondary | Maternal Health Component: Incidence of HIV/AIDS-related Events | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | "HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group. |
| Secondary | Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. |
| Secondary | Maternal Health Component: Other Targeted Medical Conditions | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others. |
| Secondary | Maternal Health Component: Incidence of HIV/AIDS-related Event or Death | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | "HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group. |
| Secondary | Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | "HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group. |
| Secondary | Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern | From study entry until July 7, 2015, an average of 94 weeks of follow-up. | Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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