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| ID | Type | Description | Link |
|---|---|---|---|
| 10770 | Registry Identifier | DAIDS ES Registry Number | |
| NICHD P1081 | |||
| HHSN2752018000011. | Other Grant/Funding Number | NICHD | |
| UM1AI068616 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late stages of pregnancy need an effective medication regimen to reduce the risk of transmitting HIV to their children. This study examined the virologic response, safety, and tolerability of two different ARV medication regimens in HIV-infected pregnant women who were between 20 and 36 weeks pregnant when they entered the study.
When initiating this study there were many ARV medications and combination regimens available to treat HIV-infected people. However, the number of ARV medications that had been studied in HIV-infected pregnant women for the prevention of mother-to-child transmission was limited. Although HIV-infected pregnant women who began taking ARV medications late in their pregnancies required effective therapy to reduce the risk of transmitting HIV to their children, there were no published data available that compared the effects of non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitors (which are two classes of ARV medications) in pregnant women. The purpose of this study was to compare the safety, tolerability, and virologic responses to two different medication regimens, each of which included an NNRTI or integrase inhibitor, in pregnant HIV-infected women who began ARV therapy late in their pregnancies (i.e., had gestational age between 20 and 36 weeks).
This study was originally opened under IMPAACT P1081, protocol version 2.0 (version 1.0 never opened to accrual) as a three arm study. However, IMPAACT P1081 was closed due to slow accrual, at which point NICHD took over the study, streamlined it to two arms, and reopened it as NICHD P1081 under protocol Version 3.0. Women who enrolled under IMPAACT P1081 (N=20) and were randomized to one of the two continuing arms (efavirenz- or raltegravir-based ART; N=14) were included in NICHD P1081, while IMPAACT P1081 women randomized to the dropped arm (lopinavir/ritonavir-based ART; N=6) were not eligible for inclusion in NICHD P1081.
In this study HIV-infected pregnant women were randomly assigned to one of two arms. Women in Arm A received lamivudine 150 mg/zidovudine 300 mg twice a day and efavirenz 600 mg each night. Women in Arm B received lamivudine 150 mg/zidovudine 300 mg twice a day and raltegravir 400 mg twice a day. All women were scheduled to receive their assigned medications from study entry through delivery. Antepartum study visits were scheduled at entry and Weeks 1, 2, and 4; and thereafter, every two weeks until labor and delivery. Study visits included a medical history review, physical examination, questionnaires, blood collection, and a vaginal swab procedure.
While women were in labor, they were scheduled to continue to receive their study medications. Some women may have received additional or alternate medications according to local standard of care/guidelines. Women had a physical examination and blood collection at the delivery visit. After delivery, some women continued to receive ARV medications according to the local guidelines, and could have received study ARV for up to eight weeks postpartum while they transitioned to the ARV regimen indicated per their local standard of care. Women were scheduled to attend study visits following delivery at Weeks 2, 6, 16, and 24, which included a medical history review, physical examination, and blood collection. Select visits were scheduled to include a vaginal swab procedure. Some women had vaginal specimens stored for future research.
Infants delivered on study were scheduled to receive ARV medications as prescribed by the babies' doctors per local standard of care/guidelines. Study visits for infants were scheduled at birth, and at Weeks 2, 6, 16, and 24. Each study visit included a medical history review, physical examination, and blood collection. Select visits included oral and nasopharyngeal swab collection.Some infants had oral and/or nasopharyngeal specimens stored for future research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Women) | Experimental | Pregnant women received ZDV/3TC + EFV |
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| Arm B (Women) | Experimental | Pregnant women received ZDV/3TC + RAL |
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| Arm A (Infants) | No Intervention | Infants born to women in Arm A; infants received no study intervention. | |
| Arm B (Infants) | No Intervention | Infants born to women in Arm B; infants received no study intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine/zidovudine | Drug | Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered. | Measured at participants' delivery visit (or last visit within three weeks prior to delivery) |
| Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery. | Only women who initiated (i.e. received at least one dose of) their randomized treatment were eligible for this outcome measure. Women were considered to have discontinued study drug if they stopped receiving efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason, including loss to follow-up. | Measured from entry through participants' delivery visit (approximately 36 to 40 weeks gestation) |
| Proportion of Women Who Experienced at Least One New Adverse Event of Greater Than or Equal to Grade 3 as Defined in the Division of AIDS (DAIDS) Toxicity Table | "New" adverse events were those with an onset date on or after randomization. Adverse events present at baseline would only be considered "New" if they increased in grade on or after randomization. All women who received at least one dose of study drug were eligible for this analysis. | Measured from entry through participants' last study visit, approximately 24 weeks after delivery |
| Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3. | All infants who were live births on study were eligible for this analysis. Adverse event grades were defined based on the DAIDS toxicity table. | Measured from birth through infants' last study visit, approximately 24 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery | A successful outcome was defined as maternal HIV-1 RNA plasma viral load less than the lower limit of quantification (LLQ) for the testing assay, which could vary. Most (99%) women had their viral load measured using an assay with LLQ equal to 40 or 20 copies/mL. If the viral load at delivery was missing, the last observed viral load within 21 days prior to the delivery date was considered. |
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Inclusion Criteria:
Exclusion Criteria:
Active labor defined as onset of regular contractions or cervical dilatation greater than 2 cm
Use of ART during current pregnancy
Chemotherapy for active malignancy
HIV genotypic resistance, as defined in the protocol, to efavirenz or raltegravir or to NRTIs that will be included in the ART regimen. Note: A lack of HIV drug resistance test results at the time of enrollment is not exclusionary.
Serious active opportunistic infection and/or serious bacterial infection including active tuberculosis (TB) or unstable or severe medical condition within 14 days of study entry
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study
Vomiting or inability to swallow medications due to an active, pre-existing condition that prevents adequate swallowing and absorption of study medication
Known allergy/sensitivity to any study drugs or their formulations or sulfonamide allergy
The following laboratory values (within 30 days of enrollment):
Evidence of pre-eclampsia (such as persistent diastolic blood pressure greater than 90 mm Hg)
Receipt of disallowed medications as described in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Esau Joao, M.D. | Hospital Federal dos Servidores do Estado - RJ | Study Chair |
| Mark Mirochnick, M.D. | Boston Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Flordia Childrens Diagnostic & Treatment Center | Fort Lauderdale | Florida | 33316 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32386720 | Derived | Joao EC, Morrison RL, Shapiro DE, Chakhtoura N, Gouvea MIS, de Lourdes B Teixeira M, Fuller TL, Mmbaga BT, Ngocho JS, Njau BN, Violari A, Mathiba R, Essack Z, Pilotto JHS, Moreira LF, Rolon MJ, Cahn P, Prommas S, Cressey TR, Chokephaibulkit K, Werarak P, Laimon L, Hennessy R, Frenkel LM, Anthony P, Best BM, Siberry GK, Mirochnick M. Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial. Lancet HIV. 2020 May;7(5):e322-e331. doi: 10.1016/S2352-3018(20)30038-2. |
| Label | URL |
|---|---|
| The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014 (Corrected to Version 2.1, July 2017). | View source |
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Individual participant data that underlie results in the publication, after deidentification.
Beginning 9 months following publication and available throughout period of funding of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) by NIH.
With whom? Researchers whose proposed use of the data is approved by the NICHD Data and Specimen Hub (DASH) Data Access Committee as scientifically and ethically appropriate and does not conflict with constraints or informed consent limitations.
For what types of analyses? To achieve aims in the approved proposal. By what mechanism will data be made available? To gain access, data requestors will need to create a free NICHD DASH account, submit a data access proposal, and if approved, sign a data access agreement. Information regarding creating a NICHD DASH account and accessing data may be found at https://dash.nichd.nih.gov/
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Participants were randomized 1-to-1 to Arm A (efavirenz) or Arm B (raltegravir) with stratification by gestational age at enrollment (20 to <28 weeks; 28 to <31 weeks; 31 to <34 weeks; 34 to <37 weeks) and NRTI backbone (lamivudine/zidovudine or alternative, locally-supplied NRTI regimen), and dynamic balancing by study site.
IMPAACT P1081 (protocol version 2.0) enrolled participants from September, 2013 through November, 2014. Enrollment under NICHD P1081 (protocol version 3.0) resumed in July 2015 and continued through February, 2018. Participants enrolled at sites in Argentina (2), Brazil (7), South Africa (1), Tanzania (1), Thailand (3), and the United States (5).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Women) | Pregnant women received ZDV/3TC + EFV Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2019 | Dec 9, 2019 |
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| Efavirenz | Drug | Participants received one 600 mg tablet of efavirenz each night from entry through delivery. |
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| Raltegravir | Drug | Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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| Measured at participants' delivery visit (or last visit within three weeks prior to delivery) |
| Proportion of Women With 1) Successful Viral Load (Plasma HIV-1 RNA VL) Decrease From Entry to Week 2 and VL Less Than 1,000 Copies/ml at All Time Points After 4 Weeks on Study Drugs, Until Delivery; and 2) Who Remain on the Assigned Study Regimen | A successful viral load decrease was defined as follows: for women having HIV-1 RNA viral load greater than or equal to 10,000 copies/mL at entry, a viral load <200 copies/mL; for women with VL less than 10,000 copies/mL at entry, a Log10 viral load decrease of at least 2.0 from entry. | Measured from entry through delivery (approximately 36 to 40 weeks gestation). |
| Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery | Change in viral load from entry (or screening, if there was no entry viral load) to each study week prior to delivery, calculated on the log10 scale as log10(week X RNA) - log10(baseline RNA). For this analysis, HIV-1 RNA values that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1. | Measured at antepartum Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16. |
| Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation | The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose). | Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery |
| Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation | The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose). Vaginal swabs produce much less testable sample volume than blood plasma draws. Each vaginal swab specimen had to be diluted, and this dilution factor raised the lower limit of quantification (LLQ). The most commonly observed LLQs were 300 and 1200. For consistency, the higher LLQ was considered the threshold for this outcome measure. | Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery |
| Infectivity of Plasma | The goal of this outcome measure was to address an objective relevant to protease inhibitors, one of which was originally included as a third arm in the Version 2.0 of the study. This outcome measure was included to assess how the infectivity of plasma changed over time among women receiving protease inhibitors, and whether this differed from other classes of antiretroviral drugs. However, the lopinavir/ritonavir arm was later dropped in Version 3.0, and only Version 2.0 women who received efavirenz or raltegravir were included in the study analyses. Therefore, because no women included in the study analyses received lopinavir/ritonavir, this outcome measure was not analyzed. | Measured on or after delivery up to participants' last postpartum study visit (approximately 26 weeks after delivery) |
| Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise. | The unit of analysis was the mother-infant set. All sets where the woman received at least one dose of study treatment and remained on study through delivery were eligible. In the case of twins, the worst outcome (i.e. a stillbirth) was used. | Measured at delivery (approximately 36 to 40 weeks gestation) |
| Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation) | The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having a premature delivery if any infant in the mother-infant set was delivered prior to 37 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 37 weeks gestation then this set would count as one premature delivery outcome). All mother-infant sets that delivered at least one live birth on study were eligible for this outcome. | Measured at delivery (within 72 hours). |
| Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation). | The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having an extremely premature delivery if any infant in the mother-infant set was delivered prior to 34 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 34 weeks gestation then this set would count as one extremely premature delivery outcome). Only women who enrolled prior to 34 weeks gestation were included in this analysis. Those that enrolled from 34 to less than 37 weeks gestation were excluded because they were already past the gestational age where this outcome could have occurred at entry. | At delivery (within 72 hours). |
| Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams) | The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 3,000 grams, this mother-infant set would count as one instance of low birth weight in analysis because at least one of the infants had the outcome). | Measured within 72 hours after delivery |
| Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams). | The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 1,000 grams, this mother-infant set would count as one instance of extremely low birth weight in analysis because at least one of the infants had the outcome). | Measured within 72 hours after delivery |
| Infant HIV Infection Status (Per International Maternal Pediatric Adolescent AIDS Clinical Trials Group [IMPAACT] Definitions) | Infants were considered infected if they had both a positive HIV nucleic acid test and a subsequent confirmatory test on a different sample. Uninfected infants were those that had no positive test results and negative test results obtained at two or more of the following visits: Week 6, Week 16, and/or Week 24 postpartum. | Measured from birth through infants' last study visit at Week 24 |
| Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs | Genotypic resistance to each class of study drug (reverse transcriptase inhibitors and integrase inhibitors) was assessed separately among HIV infected infants. | Measured on or after confirmation of HIV-infection up to the infants' last study visit at Week 24 |
| Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods. | Consensus sequencing was performed on a sample from screening. Women were evaluated for integrase and reverse transcriptase resistance mutations separately. Additionally, consensus sequencing was performed among women who had an inadequate virologic response (defined in the protocol) on a sample taken at that time of inadequate virologic response. Genotypic resistance among women who stopped antiretroviral therapy was not assessed. Because World Health Organization guidelines have been updated to indicate all people living with HIV should remain on antiretroviral therapy, even postpartum women, no women stopped antiretroviral therapy after delivery. Therefore, this aspect of the outcome measure is no longer relevant and was not assessed. | Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery). |
| Tulane University |
| New Orleans |
| Louisiana |
| 70118 |
| United States |
| St Jude's Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Hosp. General de Agudos Buenos Aires Argentina NICHD CRS | Ciudad de Buenos Aires | Buenos Aires | C1221ADC | Argentina |
| Fundacion Huesped - Hospital Juan A Fernandez | Buenos Aires | Argentina |
| SOM Federal University Minas Gerais Brazil NICHD CRS | Belo Horizonte | Minas Gerais | 30.130-100 | Brazil |
| Univ. Caxias do Sul Brazil NICHD CRS | Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Hospital Nossa Senhora da Conceicao NICHD CRS | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Hospital Federal dos Servidores do Estado NICHD CRS | Rio de Janeiro | 20221-903 | Brazil |
| Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS | Rio de Janeiro | 21941-612 | Brazil |
| Hosp. Geral De Nova Igaucu Brazil NICHD CRS | Rio de Janeiro | 26030 | Brazil |
| Univ. of Sao Paulo Brazil NICHD CRS | São Paulo | 14049-900 | Brazil |
| San Juan City Hosp. PR NICHD CRS | San Juan | 00936 | Puerto Rico |
| Perinatal HIV Research Unit-Chris Hani Baragwanath Hospital | Soweto | South Africa |
| Kilimanjaro Christian Medical Centre (KCMC) | Moshi | Tanzania |
| Siriraj Hospital ,Mahidol University NICHD CRS | Bangkok | Bangkoknoi | 10700 | Thailand |
| Bhumibol Adulyadej Hospital | Bangkok | 10220 | Thailand |
| Chiangrai Prachanukroh Hospital NICHD CRS | Chiang Mai | 50100 | Thailand |
| The Division of AIDS Manual for the Expedited Reporting of Adverse Events, Version 2.0, January 2010. | View source |
| FG001 | Arm B (Women) | Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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All women randomized to NICHD P1081 were eligible for inclusion in this summary. Additionally, the 14 women who were randomized under IMPAACT P1081 to one of the two continuing arms in NICHD P1081 were also eligible for inclusion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Women) | Pregnant women received ZDV/3TC + EFV Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery. |
| BG001 | Arm B (Women) | Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HIV-1 RNA Plasma Viral Load | Five women (two in the Arm A and three in Arm B) were missing HIV-1 RNA viral load at entry. | Median | Inter-Quartile Range | Log10 copies/mL |
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| Absolute CD4 Count | Eleven women (seven in Arm A and four in Arm B) were missing absolute CD4 cell count at baseline. | Median | Inter-Quartile Range | cells/mm^3 |
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| NRTI Background Regimen | Count of Participants | Participants |
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| Gestational Age | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery | If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered. | Eligible women were those with plasma HIV-1 RNA viral load at (or within three weeks prior to) delivery. Evaluable women had HIV-1 RNA plasma viral load greater than or equal to 200 at entry (i.e. did not already have the outcome) and had resistance testing results (on a sample taken at screening) showing no genotypic resistance to any study drug. | Posted | Number | Proportion | Measured at participants' delivery visit (or last visit within three weeks prior to delivery) |
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| Primary | Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery. | Only women who initiated (i.e. received at least one dose of) their randomized treatment were eligible for this outcome measure. Women were considered to have discontinued study drug if they stopped receiving efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason, including loss to follow-up. | Five women (all in Arm A) never initiated treatment, and thus were not included in this outcome measure. | Posted | Number | Proportion | Measured from entry through participants' delivery visit (approximately 36 to 40 weeks gestation) |
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| Primary | Proportion of Women Who Experienced at Least One New Adverse Event of Greater Than or Equal to Grade 3 as Defined in the Division of AIDS (DAIDS) Toxicity Table | "New" adverse events were those with an onset date on or after randomization. Adverse events present at baseline would only be considered "New" if they increased in grade on or after randomization. All women who received at least one dose of study drug were eligible for this analysis. | Five women (all in Arm A) never initiated their assigned study treatment and were not included in this analysis. | Posted | Number | Propotion | Measured from entry through participants' last study visit, approximately 24 weeks after delivery |
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| Primary | Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3. | All infants who were live births on study were eligible for this analysis. Adverse event grades were defined based on the DAIDS toxicity table. | All live born infants were included in this analysis. | Posted | Number | Proportion | Measured from birth through infants' last study visit, approximately 24 weeks after delivery |
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| Secondary | Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery | A successful outcome was defined as maternal HIV-1 RNA plasma viral load less than the lower limit of quantification (LLQ) for the testing assay, which could vary. Most (99%) women had their viral load measured using an assay with LLQ equal to 40 or 20 copies/mL. If the viral load at delivery was missing, the last observed viral load within 21 days prior to the delivery date was considered. | Eligible women were those that had a plasma HIV-1 RNA viral load at (or within 21 days prior to) delivery. Evaluable women were those with HIV-1 RNA viral load >200 copies/mL at baseline, and results from genotypic testing performed on a sample taken at screening indicating no genotypic resistance to any study drug. | Posted | Number | Proportion | Measured at participants' delivery visit (or last visit within three weeks prior to delivery) |
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| Secondary | Proportion of Women With 1) Successful Viral Load (Plasma HIV-1 RNA VL) Decrease From Entry to Week 2 and VL Less Than 1,000 Copies/ml at All Time Points After 4 Weeks on Study Drugs, Until Delivery; and 2) Who Remain on the Assigned Study Regimen | A successful viral load decrease was defined as follows: for women having HIV-1 RNA viral load greater than or equal to 10,000 copies/mL at entry, a viral load <200 copies/mL; for women with VL less than 10,000 copies/mL at entry, a Log10 viral load decrease of at least 2.0 from entry. | Women were evaluable for this outcome measure if they had (1) a valid viral load result at Week 2 (day 11-17 after initiation of study drug), (2) initiated study drug, and (3) delivered on- study; evaluable women who delivered after 28 days on study drug additionally had (4) at least one viral load result after 28 days on study drug. | Posted | Number | Proportion | Measured from entry through delivery (approximately 36 to 40 weeks gestation). |
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| Secondary | Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery | Change in viral load from entry (or screening, if there was no entry viral load) to each study week prior to delivery, calculated on the log10 scale as log10(week X RNA) - log10(baseline RNA). For this analysis, HIV-1 RNA values that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1. | Women were included in each week below if they had not delivered prior to that week and had an RNA viral load result for that antepartum visit. | Posted | Median | Inter-Quartile Range | Log10 copies/mL | Measured at antepartum Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16. |
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| Secondary | Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation | The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose). | Women were evaluable for Week 4 and/or Week 6 if they did not deliver prior to that study week and had at least one HIV-1 RNA plasma viral load obtained within 4 days of the target date from treatment initiation | Posted | Number | Proportion | Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery |
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| Secondary | Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation | The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose). Vaginal swabs produce much less testable sample volume than blood plasma draws. Each vaginal swab specimen had to be diluted, and this dilution factor raised the lower limit of quantification (LLQ). The most commonly observed LLQs were 300 and 1200. For consistency, the higher LLQ was considered the threshold for this outcome measure. | Participants were included if they had a valid RNA results at Week 4 and/or Week 6, and had not delivered prior to obtaining the viral load measurement for that week. | Posted | Number | Proportion | Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery |
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| Secondary | Infectivity of Plasma | The goal of this outcome measure was to address an objective relevant to protease inhibitors, one of which was originally included as a third arm in the Version 2.0 of the study. This outcome measure was included to assess how the infectivity of plasma changed over time among women receiving protease inhibitors, and whether this differed from other classes of antiretroviral drugs. However, the lopinavir/ritonavir arm was later dropped in Version 3.0, and only Version 2.0 women who received efavirenz or raltegravir were included in the study analyses. Therefore, because no women included in the study analyses received lopinavir/ritonavir, this outcome measure was not analyzed. | Because the study arm that was associated with this outcome measure was dropped, no women were assessed for this outcome. | Posted | Measured on or after delivery up to participants' last postpartum study visit (approximately 26 weeks after delivery) |
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| Secondary | Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise. | The unit of analysis was the mother-infant set. All sets where the woman received at least one dose of study treatment and remained on study through delivery were eligible. In the case of twins, the worst outcome (i.e. a stillbirth) was used. | Fourteen women (8 in Arm A and 6 in Arm B) were off-study prior to delivery (including the 5 women in Arm A who never initiated study treatment). | Posted | Number | Proportion | Measured at delivery (approximately 36 to 40 weeks gestation) |
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| Secondary | Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation) | The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having a premature delivery if any infant in the mother-infant set was delivered prior to 37 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 37 weeks gestation then this set would count as one premature delivery outcome). All mother-infant sets that delivered at least one live birth on study were eligible for this outcome. | There were 393 live-birth infants on study. There were three sets of twins, leaving 390 mother-infant sets that delivered at least one live birth on study. Five sets (three EFV and two RAL) did not have gestational age at delivery recorded and were excluded, leaving 385 sets included in this outcome. | Posted | Number | Proportion | Measured at delivery (within 72 hours). |
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| Secondary | Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation). | The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having an extremely premature delivery if any infant in the mother-infant set was delivered prior to 34 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 34 weeks gestation then this set would count as one extremely premature delivery outcome). Only women who enrolled prior to 34 weeks gestation were included in this analysis. Those that enrolled from 34 to less than 37 weeks gestation were excluded because they were already past the gestational age where this outcome could have occurred at entry. | There were 393 live-birth infants on study. There were three sets of twins, leaving 390 mother-infant sets that delivered at least one live birth on study. Among these, five were missing gestational age at delivery (three EFV and two RAL sets) and 45 were enrolled from 34 to less than 37 weeks gestation and excluded, leaving 340 evaluable sets. | Posted | Number | Proportion | At delivery (within 72 hours). |
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| Secondary | Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams) | The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 3,000 grams, this mother-infant set would count as one instance of low birth weight in analysis because at least one of the infants had the outcome). | All women who delivered at least one live-birth infant on-study were included in this analysis. Although 393 live-born infants were delivered, there were three sets of twins. Therefore, 390 mother-infant pairs were included in this analysis. | Posted | Number | Proportion | Measured within 72 hours after delivery |
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| Secondary | Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams). | The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 1,000 grams, this mother-infant set would count as one instance of extremely low birth weight in analysis because at least one of the infants had the outcome). | All women who delivered at least one live-birth infant on-study were included in this analysis. Although 393 live-born infants were delivered, there were three sets of twins. Therefore, 390 mother-infant pairs were included in this analysis. | Posted | Number | Proportion | Measured within 72 hours after delivery |
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| Secondary | Infant HIV Infection Status (Per International Maternal Pediatric Adolescent AIDS Clinical Trials Group [IMPAACT] Definitions) | Infants were considered infected if they had both a positive HIV nucleic acid test and a subsequent confirmatory test on a different sample. Uninfected infants were those that had no positive test results and negative test results obtained at two or more of the following visits: Week 6, Week 16, and/or Week 24 postpartum. | Infants who had no positive test result, but did not have negative results at at least two of Week 6, 16, and/or 24 postpartum visits were not eligible for this analysis. All infants who had at least one positive test also had a positive confirmation test, and are included in this outcome. | Posted | Count of Participants | Participants | Measured from birth through infants' last study visit at Week 24 |
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| Secondary | Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs | Genotypic resistance to each class of study drug (reverse transcriptase inhibitors and integrase inhibitors) was assessed separately among HIV infected infants. | One infant in the efavirenz arm did not have a specimen collected with sufficient viral load to perform consensus sequencing. All other infected infants had genotypic resistance results for both classes of study drug. | Posted | Number | Proportion | Measured on or after confirmation of HIV-infection up to the infants' last study visit at Week 24 |
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| Secondary | Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods. | Consensus sequencing was performed on a sample from screening. Women were evaluated for integrase and reverse transcriptase resistance mutations separately. Additionally, consensus sequencing was performed among women who had an inadequate virologic response (defined in the protocol) on a sample taken at that time of inadequate virologic response. Genotypic resistance among women who stopped antiretroviral therapy was not assessed. Because World Health Organization guidelines have been updated to indicate all people living with HIV should remain on antiretroviral therapy, even postpartum women, no women stopped antiretroviral therapy after delivery. Therefore, this aspect of the outcome measure is no longer relevant and was not assessed. | Women were excluded if they had indeterminate or unknown resistance results for that class of antiretroviral study drug. | Posted | Number | Proportion | Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery). |
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Adverse event data were collected from entry (20-36 weeks gestation) through delivery for women. Additionally, both women and infants had adverse event data collected from delivery through their final study visit which was scheduled to occur at Week 24 postpartum.
Serious adverse events and deaths were reported among all women and live-birth infants. Only women who received at least one dose of study drug (and their infants) were included in the assessment of "other" events, which included grade 3 or higher signs/symptoms, laboratory events, and diagnoses that occurred in at least 5 percent of women (or infants) in at least one arm.
The DAIDS AE Grading Table (V2.0) and EAE Manual (V2.0) were used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Women) | Pregnant women received ZDV/3TC + EFV Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery. | 0 | 197 | 34 | 202 | 20 | 197 |
| EG001 | Arm B (Women) | Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. | 1 | 206 | 34 | 206 | 24 | 206 |
| EG002 | Arm A (Infants) | Infants born to women in Arm A; infants received no study intervention. | 1 | 194 | 31 | 194 | 20 | 194 |
| EG003 | Arm B (Infants) | Infants born to women in Arm B; infants received no study intervention. | 1 | 199 | 50 | 199 | 15 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| ABO incompatibility | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac murmer | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Congenital cytomegalovirus infection | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Congenital pneumonia | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Congenital syphilis | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Congenital toxoplasmosis | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Genitalia external ambiguous | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Hepatic rupture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Herpes simplex encephalitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
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| Hyperbilirubinaemia neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypospadias | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Neonatal asphyxia | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
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| Neonatal respiratory distress | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Pelvis abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Premature labor | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Puerperal pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary artery stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary valve stenosis | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Sepsis neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Sudden infant death syndrome | General disorders | MedDRA (22.1) | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Transient tachypnoea of the newborn | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Tricuspid valve incompetance | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Umbilical cord around neck | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ankyloglossia | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Single umbilical artery | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Infection prophylaxis | Surgical and medical procedures | MedDRA (22.1) | Systematic Assessment |
| |
| Macrocephaly | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Foetal malformation | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Extrapulmonary tuberculosis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Congenital skin dimples | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Meconium aspiration syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoglobin decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Congenital syphilis | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
|
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Laimon, Project Manager | Westat | 240-453-2987 | laurenlaimon@westat.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 2, 2015 | Dec 9, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C109078 | lamivudine, zidovudine drug combination |
| C098320 | efavirenz |
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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| Black, Not Hispanic |
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| Hispanic, Latino |
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| White, Not Hispanic |
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| Unknown |
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| Puerto Rico |
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| United States |
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| Tanzania |
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| Brazil |
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| South Africa |
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| Thailand |
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Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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Pregnant women received ZDV/3TC + RAL
Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.
* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization.
Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery.
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| OG001 | Arm B (Women) | Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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| OG001 | Arm B (Women) | Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*. * Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. |
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