Trial Outcomes & Findings for Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission (NCT NCT01618305)

Last Updated: 2020-01-30

Results Overview

If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

408 participants

Primary outcome timeframe

Measured at participants' delivery visit (or last visit within three weeks prior to delivery)

Results posted on

2020-01-30

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	202	206
Overall Study COMPLETED	187	196
Overall Study NOT COMPLETED	15	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	0	1
Overall Study Lost to Follow-up	11	7
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Five women (two in the Arm A and three in Arm B) were missing HIV-1 RNA viral load at entry.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Women) n=202 Participants 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.	Arm B (Women) n=206 Participants 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.	Total n=408 Participants Total of all reporting groups
Age, Continuous	25.4 years n=202 Participants	26.9 years n=206 Participants	26.5 years n=408 Participants
Sex: Female, Male Female	202 Participants n=202 Participants	206 Participants n=206 Participants	408 Participants n=408 Participants
Sex: Female, Male Male	0 Participants n=202 Participants	0 Participants n=206 Participants	0 Participants n=408 Participants
Race/Ethnicity, Customized Asian, Pacific Islander	24 Participants n=202 Participants	23 Participants n=206 Participants	47 Participants n=408 Participants
Race/Ethnicity, Customized Black, Not Hispanic	74 Participants n=202 Participants	72 Participants n=206 Participants	146 Participants n=408 Participants
Race/Ethnicity, Customized Hispanic, Latino	101 Participants n=202 Participants	108 Participants n=206 Participants	209 Participants n=408 Participants
Race/Ethnicity, Customized White, Not Hispanic	1 Participants n=202 Participants	2 Participants n=206 Participants	3 Participants n=408 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=202 Participants	1 Participants n=206 Participants	3 Participants n=408 Participants
Region of Enrollment Argentina	8 participants n=202 Participants	12 participants n=206 Participants	20 participants n=408 Participants
Region of Enrollment Puerto Rico	0 participants n=202 Participants	2 participants n=206 Participants	2 participants n=408 Participants
Region of Enrollment United States	4 participants n=202 Participants	1 participants n=206 Participants	5 participants n=408 Participants
Region of Enrollment Tanzania	42 participants n=202 Participants	42 participants n=206 Participants	84 participants n=408 Participants
Region of Enrollment Brazil	94 participants n=202 Participants	96 participants n=206 Participants	190 participants n=408 Participants
Region of Enrollment South Africa	30 participants n=202 Participants	30 participants n=206 Participants	60 participants n=408 Participants
Region of Enrollment Thailand	24 participants n=202 Participants	23 participants n=206 Participants	47 participants n=408 Participants
HIV-1 RNA Plasma Viral Load	4.1 Log10 copies/mL n=200 Participants • Five women (two in the Arm A and three in Arm B) were missing HIV-1 RNA viral load at entry.	4.1 Log10 copies/mL n=203 Participants • Five women (two in the Arm A and three in Arm B) were missing HIV-1 RNA viral load at entry.	4.1 Log10 copies/mL n=403 Participants • Five women (two in the Arm A and three in Arm B) were missing HIV-1 RNA viral load at entry.
Absolute CD4 Count	408 cells/mm^3 n=195 Participants • Eleven women (seven in Arm A and four in Arm B) were missing absolute CD4 cell count at baseline.	389.5 cells/mm^3 n=202 Participants • Eleven women (seven in Arm A and four in Arm B) were missing absolute CD4 cell count at baseline.	395 cells/mm^3 n=397 Participants • Eleven women (seven in Arm A and four in Arm B) were missing absolute CD4 cell count at baseline.
NRTI Background Regimen Zidovudine and Lamivudine (ZDV/3TC)	170 Participants n=202 Participants	171 Participants n=206 Participants	341 Participants n=408 Participants
NRTI Background Regimen Emtricitabine and Tenofovir (FTC/TDF)	31 Participants n=202 Participants	33 Participants n=206 Participants	64 Participants n=408 Participants
NRTI Background Regimen Lamivudine and Tenofovir (3TC/TDF)	1 Participants n=202 Participants	2 Participants n=206 Participants	3 Participants n=408 Participants
Gestational Age 20-<28 weeks	102 Participants n=202 Participants	103 Participants n=206 Participants	205 Participants n=408 Participants
Gestational Age 28-<31 weeks	48 Participants n=202 Participants	50 Participants n=206 Participants	98 Participants n=408 Participants
Gestational Age 31-<34 weeks	31 Participants n=202 Participants	29 Participants n=206 Participants	60 Participants n=408 Participants
Gestational Age 34-<37 weeks	21 Participants n=202 Participants	24 Participants n=206 Participants	45 Participants n=408 Participants

PRIMARY outcome

Timeframe: Measured at participants' delivery visit (or last visit within three weeks prior to delivery)

Population: 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.

If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=154 Participants 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.	Arm B (Women) n=153 Participants 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.
Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery	.84 Proportion	.94 Proportion

PRIMARY outcome

Timeframe: Measured from entry through participants' delivery visit (approximately 36 to 40 weeks gestation)

Population: Five women (all in Arm A) never initiated treatment, and thus were not included in this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=197 Participants 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.	Arm B (Women) n=206 Participants 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.
Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery.	.05 Proportion	.03 Proportion

PRIMARY outcome

Timeframe: Measured from entry through participants' last study visit, approximately 24 weeks after delivery

Population: Five women (all in Arm A) never initiated their assigned study treatment and were not included in this analysis.

"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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=197 Participants 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.	Arm B (Women) n=206 Participants 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.
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	.30 Propotion	.30 Propotion

PRIMARY outcome

Timeframe: Measured from birth through infants' last study visit, approximately 24 weeks after delivery

Population: All live born infants were included in this analysis.

All infants who were live births on study were eligible for this analysis. Adverse event grades were defined based on the DAIDS toxicity table.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=194 Participants 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.	Arm B (Women) n=199 Participants 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.
Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3.	.25 Proportion	.25 Proportion

SECONDARY outcome

Timeframe: Measured at participants' delivery visit (or last visit within three weeks prior to delivery)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=154 Participants 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.	Arm B (Women) n=153 Participants 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.
Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery	.58 Proportion	.86 Proportion

SECONDARY outcome

Timeframe: Measured from entry through delivery (approximately 36 to 40 weeks gestation).

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=133 Participants 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.	Arm B (Women) n=139 Participants 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.
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	.63 Proportion	.89 Proportion

SECONDARY outcome

Timeframe: Measured at antepartum Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=183 Participants 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.	Arm B (Women) n=185 Participants 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.
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 1	-1.4 Log10 copies/mL Interval -1.7 to -1.2	-1.5 Log10 copies/mL Interval -1.8 to -1.2
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 2	-1.8 Log10 copies/mL Interval -2.0 to -1.4	-2.1 Log10 copies/mL Interval -2.4 to -1.6
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 4	-2.0 Log10 copies/mL Interval -2.3 to -1.6	-2.4 Log10 copies/mL Interval -2.8 to -1.6
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 6	-2.1 Log10 copies/mL Interval -2.5 to -1.7	-2.4 Log10 copies/mL Interval -3.0 to -1.7
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 8	-2.2 Log10 copies/mL Interval -2.6 to -1.7	-2.4 Log10 copies/mL Interval -3.0 to -1.7
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 10	-2.3 Log10 copies/mL Interval -2.7 to -1.8	-2.3 Log10 copies/mL Interval -3.0 to -1.7
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 12	-2.4 Log10 copies/mL Interval -2.7 to -1.9	-2.5 Log10 copies/mL Interval -3.0 to -1.8
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 14	-2.5 Log10 copies/mL Interval -2.6 to -1.9	-2.5 Log10 copies/mL Interval -3.0 to -1.8
Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery Week 16	-2.5 Log10 copies/mL Interval -2.7 to -1.8	-2.7 Log10 copies/mL Interval -3.0 to -2.1

SECONDARY outcome

Timeframe: Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery

Population: 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

Outcome measures

Outcome measures
Measure	Arm A (Women) n=170 Participants 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.	Arm B (Women) n=176 Participants 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.
Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation Week 6	.85 Proportion	.96 Proportion
Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation Week 4	.75 Proportion	.95 Proportion

SECONDARY outcome

Timeframe: Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=159 Participants 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.	Arm B (Women) n=168 Participants 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.
Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation Week 4	.97 Proportion	.95 Proportion
Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation Week 6	.98 Proportion	.94 Proportion

SECONDARY outcome

Timeframe: Measured on or after delivery up to participants' last postpartum study visit (approximately 26 weeks after delivery)

Population: Because the study arm that was associated with this outcome measure was dropped, no women were assessed for this outcome.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at delivery (approximately 36 to 40 weeks gestation)

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=194 Participants 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.	Arm B (Women) n=200 Participants 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.
Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise.	.005 Proportion	.015 Proportion

SECONDARY outcome

Timeframe: Measured at delivery (within 72 hours).

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=190 Participants 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.	Arm B (Women) n=195 Participants 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.
Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation)	.105 Proportion	.123 Proportion

SECONDARY outcome

Timeframe: At delivery (within 72 hours).

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=169 Participants 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.	Arm B (Women) n=171 Participants 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.
Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation).	.036 Proportion	.023 Proportion

SECONDARY outcome

Timeframe: Measured within 72 hours after delivery

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Arm A (Women) n=193 Participants 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.	Arm B (Women) n=197 Participants 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.
Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams)	.124 Proportion	.127 Proportion

SECONDARY outcome

Timeframe: Measured within 72 hours after delivery

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).

Outcome measures

Outcome measures
Measure	Arm A (Women) n=193 Participants 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.	Arm B (Women) n=197 Participants 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.
Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams).	.000 Proportion	.005 Proportion

SECONDARY outcome

Timeframe: Measured from birth through infants' last study visit at Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=184 Participants 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.	Arm B (Women) n=190 Participants 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.
Infant HIV Infection Status (Per International Maternal Pediatric Adolescent AIDS Clinical Trials Group [IMPAACT] Definitions) HIV-infected	6 Participants	1 Participants
Infant HIV Infection Status (Per International Maternal Pediatric Adolescent AIDS Clinical Trials Group [IMPAACT] Definitions) HIV-uninfected	178 Participants	189 Participants

SECONDARY outcome

Timeframe: Measured on or after confirmation of HIV-infection up to the infants' last study visit at Week 24

Population: 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.

Genotypic resistance to each class of study drug (reverse transcriptase inhibitors and integrase inhibitors) was assessed separately among HIV infected infants.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=5 Participants 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.	Arm B (Women) n=1 Participants 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.
Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs Reverse transcriptase resistance	.20 Proportion	.00 Proportion
Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs Integrase resistance	.00 Proportion	.00 Proportion

SECONDARY outcome

Timeframe: Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery).

Population: Women were excluded if they had indeterminate or unknown resistance results for that class of antiretroviral study drug.

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.

Outcome measures

Outcome measures
Measure	Arm A (Women) n=190 Participants 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.	Arm B (Women) n=197 Participants 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.
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. Reverse transcriptase resistance at screening	.07 Proportion	.11 Proportion
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. Integrase resistance at screening	.00 Proportion	.00 Proportion
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. Reverse transcriptase resistance at viral failure	.60 Proportion	.30 Proportion
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. Integrase resistance at viral failure	—	.00 Proportion

Adverse Events

Arm A (Women)

Serious events: 34 serious events

Other events: 20 other events

Deaths: 0 deaths

Arm B (Women)

Serious events: 34 serious events

Other events: 24 other events

Deaths: 1 deaths

Arm A (Infants)

Serious events: 31 serious events

Other events: 20 other events

Deaths: 1 deaths

Arm B (Infants)

Serious events: 50 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm A (Women) n=197 participants at risk；n=202 participants at risk 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.	Arm B (Women) n=206 participants at risk 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.	Arm A (Infants) n=194 participants at risk Infants born to women in Arm A; infants received no study intervention.	Arm B (Infants) n=199 participants at risk Infants born to women in Arm B; infants received no study intervention.
Investigations Haemoglobin decreased	10.2% 20/197 • 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.	11.7% 24/206 • 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.	5.2% 10/194 • 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.	1.5% 3/199 • 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.
Congenital, familial and genetic disorders Congenital syphilis	0.00% 0/197 • 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.	0.00% 0/206 • 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.	6.2% 12/194 • 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.	6.0% 12/199 • 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.

Additional Information

Lauren Laimon, Project Manager

Westat

Phone: 240-453-2987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER