Trial Outcomes & Findings for IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women (NCT NCT00955968)

Last Updated: 2023-08-14

Results Overview

AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1653 participants

Primary outcome timeframe

From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Results posted on

2023-08-14

Participant Flow

There were 1653 participants randomized to the study with enrollments from the US, Argentina, Botswana, Brazil, China, Haiti, and Thailand. The first participant was randomized on January 2010. The last participant was randomized in November 2014.

There were 1917 participants screened for the study, 264 of these failed screening and were not enrolled. The most common reasons for screening failure were CD4 cell count out of range, did not return for consent, test results unavailable on protocol specified time frame, not willing to participate, and not willing to remain on antiretrovirals.

Participant milestones

Participant milestones
Measure	Continue HAART Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Study STARTED	828	825
Overall Study COMPLETED	691	699
Overall Study NOT COMPLETED	137	126

Reasons for withdrawal

Reasons for withdrawal
Measure	Continue HAART Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Study Death	2	4
Overall Study Withdrawal by Subject	35	31
Overall Study Lost to Follow-up	45	39
Overall Study Site closed	55	52

Baseline Characteristics

Baseline weight and height measure were not completed for some participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.	Total n=1652 Participants Total of all reporting groups
Age, Categorical <=18 years	18 Participants n=827 Participants	18 Participants n=825 Participants	36 Participants n=1652 Participants
Age, Categorical Between 18 and 65 years	809 Participants n=827 Participants	807 Participants n=825 Participants	1616 Participants n=1652 Participants
Age, Categorical >=65 years	0 Participants n=827 Participants	0 Participants n=825 Participants	0 Participants n=1652 Participants
Age, Continuous	27 years n=827 Participants	28 years n=825 Participants	28 years n=1652 Participants
Sex: Female, Male Female	827 Participants n=827 Participants	825 Participants n=825 Participants	1652 Participants n=1652 Participants
Sex: Female, Male Male	0 Participants n=827 Participants	0 Participants n=825 Participants	0 Participants n=1652 Participants
Region of Enrollment Haiti	32 Participants n=827 Participants	29 Participants n=825 Participants	61 Participants n=1652 Participants
Region of Enrollment Argentina	20 Participants n=827 Participants	25 Participants n=825 Participants	45 Participants n=1652 Participants
Region of Enrollment United States	72 Participants n=827 Participants	77 Participants n=825 Participants	149 Participants n=1652 Participants
Region of Enrollment Botswana	230 Participants n=827 Participants	227 Participants n=825 Participants	457 Participants n=1652 Participants
Region of Enrollment China	52 Participants n=827 Participants	52 Participants n=825 Participants	104 Participants n=1652 Participants
Region of Enrollment Brazil	259 Participants n=827 Participants	255 Participants n=825 Participants	514 Participants n=1652 Participants
Region of Enrollment Thailand	156 Participants n=827 Participants	151 Participants n=825 Participants	307 Participants n=1652 Participants
Region of Enrollment Peru	6 Participants n=827 Participants	9 Participants n=825 Participants	15 Participants n=1652 Participants
Race/Ethnicity Asian	209 Participants n=827 Participants	203 Participants n=825 Participants	412 Participants n=1652 Participants
Race/Ethnicity Black or African American	58 Participants n=827 Participants	58 Participants n=825 Participants	116 Participants n=1652 Participants
Race/Ethnicity White	123 Participants n=827 Participants	127 Participants n=825 Participants	250 Participants n=1652 Participants
Race/Ethnicity American Indian	1 Participants n=827 Participants	1 Participants n=825 Participants	2 Participants n=1652 Participants
Race/Ethnicity Alaskan Native	0 Participants n=827 Participants	1 Participants n=825 Participants	1 Participants n=1652 Participants
Race/Ethnicity Black African	230 Participants n=827 Participants	227 Participants n=825 Participants	457 Participants n=1652 Participants
Race/Ethnicity Black of African origin	77 Participants n=827 Participants	70 Participants n=825 Participants	147 Participants n=1652 Participants
Race/Ethnicity Mestizo	6 Participants n=827 Participants	8 Participants n=825 Participants	14 Participants n=1652 Participants
Race/Ethnicity Mixed Black	73 Participants n=827 Participants	76 Participants n=825 Participants	149 Participants n=1652 Participants
Race/Ethnicity Mixed native	0 Participants n=827 Participants	4 Participants n=825 Participants	4 Participants n=1652 Participants
Race/Ethnicity Native (native Brazilian-Xavante/Kaigang/Guarani)	1 Participants n=827 Participants	1 Participants n=825 Participants	2 Participants n=1652 Participants
Race/Ethnicity Other	31 Participants n=827 Participants	31 Participants n=825 Participants	62 Participants n=1652 Participants
Race/Ethnicity Subject does not know	4 Participants n=827 Participants	2 Participants n=825 Participants	6 Participants n=1652 Participants
Race/Ethnicity Race not available to clinic	14 Participants n=827 Participants	16 Participants n=825 Participants	30 Participants n=1652 Participants
Body Mass Index (BMI)	24.4 kg/m^2 n=812 Participants • Baseline weight and height measure were not completed for some participants	24.6 kg/m^2 n=801 Participants • Baseline weight and height measure were not completed for some participants	24.5 kg/m^2 n=1613 Participants • Baseline weight and height measure were not completed for some participants
WHO stage at entry Clinical Stage I	810 Participants n=827 Participants • Baseline WHO staging criteria was not completed for some participants.	811 Participants n=823 Participants • Baseline WHO staging criteria was not completed for some participants.	1621 Participants n=1650 Participants • Baseline WHO staging criteria was not completed for some participants.
WHO stage at entry Clinical Stage II	16 Participants n=827 Participants • Baseline WHO staging criteria was not completed for some participants.	11 Participants n=823 Participants • Baseline WHO staging criteria was not completed for some participants.	27 Participants n=1650 Participants • Baseline WHO staging criteria was not completed for some participants.
WHO stage at entry Clinical Stage III	1 Participants n=827 Participants • Baseline WHO staging criteria was not completed for some participants.	1 Participants n=823 Participants • Baseline WHO staging criteria was not completed for some participants.	2 Participants n=1650 Participants • Baseline WHO staging criteria was not completed for some participants.
Duration of Antiretroviral therapy (ART) prior to study entry	17 weeks n=827 Participants	17 weeks n=825 Participants	17 weeks n=1652 Participants
ART regimen prior to entry HAART including boosted PI	629 Participants n=827 Participants	612 Participants n=825 Participants	1241 Participants n=1652 Participants
ART regimen prior to entry HAART including non-boosted PI	12 Participants n=827 Participants	16 Participants n=825 Participants	28 Participants n=1652 Participants
ART regimen prior to entry HAART including NNRTI [EFV]	180 Participants n=827 Participants	172 Participants n=825 Participants	352 Participants n=1652 Participants
ART regimen prior to entry HAART including NNRTI [NVP]	4 Participants n=827 Participants	8 Participants n=825 Participants	12 Participants n=1652 Participants
ART regimen prior to entry HAART including NNRTI [RPV]	1 Participants n=827 Participants	1 Participants n=825 Participants	2 Participants n=1652 Participants
ART regimen prior to entry HAART including NNRTI and PI	1 Participants n=827 Participants	0 Participants n=825 Participants	1 Participants n=1652 Participants
ART regimen prior to entry Three or more NRTIs	3 Participants n=827 Participants	11 Participants n=825 Participants	14 Participants n=1652 Participants
ART regimen prior to entry Zero NRTIs	0 Participants n=827 Participants	1 Participants n=825 Participants	1 Participants n=1652 Participants
ART regimen prior to entry HAART including II	4 Participants n=827 Participants	4 Participants n=825 Participants	8 Participants n=1652 Participants
ART regimen prior to entry HAART including PI and II	2 Participants n=827 Participants	0 Participants n=825 Participants	2 Participants n=1652 Participants
Hepatitis B surface antigen Positive	29 Participants n=821 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	28 Participants n=819 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	57 Participants n=1640 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants
Hepatitis B surface antigen Negative	771 Participants n=821 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	768 Participants n=819 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	1539 Participants n=1640 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants
Hepatitis B surface antigen Indeterminate	1 Participants n=821 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	0 Participants n=819 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	1 Participants n=1640 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants
Hepatitis B surface antigen Not obtained, Hep B antibody +ve	20 Participants n=821 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	23 Participants n=819 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants	43 Participants n=1640 Participants • Baseline Hepatitis B surface antigen was not obtained for some participants
Hepatitis B surface antibody Positive	263 Participants n=826 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	248 Participants n=823 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	511 Participants n=1649 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants
Hepatitis B surface antibody Negative	424 Participants n=826 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	425 Participants n=823 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	849 Participants n=1649 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants
Hepatitis B surface antibody Indeterminate	1 Participants n=826 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	2 Participants n=823 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	3 Participants n=1649 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants
Hepatitis B surface antibody Not obtained, Hep B antibody +ve	138 Participants n=826 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	148 Participants n=823 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants	286 Participants n=1649 Participants • Baseline Hepatitis B surface antibody was not obtained for some participants
CD4+ cell count on ART	696 cells/mm^3 n=827 Participants	695 cells/mm^3 n=825 Participants	696 cells/mm^3 n=1652 Participants
Pre-ART CD4+ cell count	550 cells/mm^3 n=827 Participants	548 cells/mm^3 n=825 Participants	549 cells/mm^3 n=1652 Participants
Plasma HIV Viral Load < 400 copies/ml	744 Participants n=822 Participants • Baseline Plasma HIV viral load was not obtained for some participants	742 Participants n=819 Participants • Baseline Plasma HIV viral load was not obtained for some participants	1486 Participants n=1641 Participants • Baseline Plasma HIV viral load was not obtained for some participants
Plasma HIV Viral Load 400 - <1000 copies/ml	30 Participants n=822 Participants • Baseline Plasma HIV viral load was not obtained for some participants	24 Participants n=819 Participants • Baseline Plasma HIV viral load was not obtained for some participants	54 Participants n=1641 Participants • Baseline Plasma HIV viral load was not obtained for some participants
Plasma HIV Viral Load 1000- <10000 copies/ml	32 Participants n=822 Participants • Baseline Plasma HIV viral load was not obtained for some participants	29 Participants n=819 Participants • Baseline Plasma HIV viral load was not obtained for some participants	61 Participants n=1641 Participants • Baseline Plasma HIV viral load was not obtained for some participants
Plasma HIV Viral Load 10000-<100000 copies/ml	15 Participants n=822 Participants • Baseline Plasma HIV viral load was not obtained for some participants	24 Participants n=819 Participants • Baseline Plasma HIV viral load was not obtained for some participants	39 Participants n=1641 Participants • Baseline Plasma HIV viral load was not obtained for some participants
Plasma HIV Viral Load >=100000 copies/ml	1 Participants n=822 Participants • Baseline Plasma HIV viral load was not obtained for some participants	0 Participants n=819 Participants • Baseline Plasma HIV viral load was not obtained for some participants	1 Participants n=1641 Participants • Baseline Plasma HIV viral load was not obtained for some participants

PRIMARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death	0.21 New cases per 100 person - years Interval 0.16 to 0.27	0.31 New cases per 100 person - years Interval 0.25 to 0.38

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rate of AIDS - Defining Illness	0.10 New cases per 100 person - years Interval 0.08 to 0.14	0.15 New cases per 100 person - years Interval 0.12 to 0.19

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event	0 New cases per 100 person - years Interval 0.0 to 0.0	0 New cases per 100 person - years Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

The incidence rate was obtained by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rate of Deaths	0.10 New cases per 100 person - years Interval 0.08 to 0.14	0.20 New cases per 100 person - years Interval 0.17 to 0.25

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rate of HIV/AIDS Related Events	1.32 New cases per 100 person - years Interval 1.07 to 1.62	1.42 New cases per 100 person - years Interval 1.16 to 1.73

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rate of HIV/AIDS Related Events or Death	1.42 New cases per 100 person - years Interval 1.16 to 1.75	1.57 New cases per 100 person - years Interval 1.3 to 1.91

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events	3.09 New cases per 100 person - years Interval 2.52 to 3.79	5.37 New cases per 100 person - years Interval 4.6 to 6.28

SECONDARY outcome

Timeframe: All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up)

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Incidence Rate of Grade 2 and Above Toxicity	18.4 New cases per 100 person - years Interval 15.7 to 21.4	15.6 New cases per 100 person - years Interval 13.2 to 18.4

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.

This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks.

Population: 156 women who were VFs had antiretroviral drug resistance testing performed.

VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2)

Outcome measures

Outcome measures
Measure	Continue HAART n=156 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm	19 Participants	—

SECONDARY outcome

Timeframe: week 0, 48 and 96

Population: Participants in the Continue HAART arm who had evaluations done at the respective weeks

Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.

Outcome measures

Outcome measures
Measure	Continue HAART n=672 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Medication Adherence - Last Time Missed Medications Week 0 · Never skipped medications	489 Participants	—
Medication Adherence - Last Time Missed Medications Week 0 · More than 1 month ago	60 Participants	—
Medication Adherence - Last Time Missed Medications Week 0 · Within the past 4 weeks	123 Participants	—
Medication Adherence - Last Time Missed Medications Week 48 · Never skipped medications	411 Participants	—
Medication Adherence - Last Time Missed Medications Week 48 · More than 1 month ago	97 Participants	—
Medication Adherence - Last Time Missed Medications Week 48 · Within the past 4 weeks	144 Participants	—
Medication Adherence - Last Time Missed Medications Week 96 · Never skipped medications	399 Participants	—
Medication Adherence - Last Time Missed Medications Week 96 · More than 1 month ago	92 Participants	—
Medication Adherence - Last Time Missed Medications Week 96 · Within the past 4 weeks	147 Participants	—

SECONDARY outcome

Timeframe: week 0, 48 and 96

Population: Participants in the Continue HAART arm who had evaluations done at the respective weeks

Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.

Outcome measures

Outcome measures
Measure	Continue HAART n=673 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Medication Adherence - How Closely Followed Schedule Week 0 · Never	23 Participants	—
Medication Adherence - How Closely Followed Schedule Week 0 · Some of the time	130 Participants	—
Medication Adherence - How Closely Followed Schedule Week 0 · All of the time	520 Participants	—
Medication Adherence - How Closely Followed Schedule Week 48 · Never	17 Participants	—
Medication Adherence - How Closely Followed Schedule Week 48 · Some of the time	173 Participants	—
Medication Adherence - How Closely Followed Schedule Week 48 · All of the time	461 Participants	—
Medication Adherence - How Closely Followed Schedule Week 96 · Never	25 Participants	—
Medication Adherence - How Closely Followed Schedule Week 96 · Some of the time	153 Participants	—
Medication Adherence - How Closely Followed Schedule Week 96 · All of the time	459 Participants	—

SECONDARY outcome

Timeframe: week 0, 48 and 96

Population: Participants in the Continue HAART arm who had evaluations done at the respective weeks

Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.

Outcome measures

Outcome measures
Measure	Continue HAART n=667 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Medication Adherence - How Often Follow Instructions Week 0 · Never	10 Participants	—
Medication Adherence - How Often Follow Instructions Week 0 · Some of the time	52 Participants	—
Medication Adherence - How Often Follow Instructions Week 0 · All of the time	166 Participants	—
Medication Adherence - How Often Follow Instructions Week 0 · No special instructions	439 Participants	—
Medication Adherence - How Often Follow Instructions Week 48 · Never	6 Participants	—
Medication Adherence - How Often Follow Instructions Week 48 · Some of the time	61 Participants	—
Medication Adherence - How Often Follow Instructions Week 48 · All of the time	194 Participants	—
Medication Adherence - How Often Follow Instructions Week 48 · No special instructions	389 Participants	—
Medication Adherence - How Often Follow Instructions Week 96 · Never	8 Participants	—
Medication Adherence - How Often Follow Instructions Week 96 · Some of the time	74 Participants	—
Medication Adherence - How Often Follow Instructions Week 96 · All of the time	190 Participants	—
Medication Adherence - How Often Follow Instructions Week 96 · No special instructions	365 Participants	—

SECONDARY outcome

Timeframe: week 0, 48 and 96

Population: Participants in the Continue HAART arm who had evaluations done at the respective weeks

Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.

Outcome measures

Outcome measures
Measure	Continue HAART n=653 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Medication Adherence - Missed Dose Within Past 4 Days Week 0 · No	592 Participants	—
Medication Adherence - Missed Dose Within Past 4 Days Week 0 · Yes	61 Participants	—
Medication Adherence - Missed Dose Within Past 4 Days Week 48 · No	564 Participants	—
Medication Adherence - Missed Dose Within Past 4 Days Week 48 · Yes	71 Participants	—
Medication Adherence - Missed Dose Within Past 4 Days Week 96 · No	544 Participants	—
Medication Adherence - Missed Dose Within Past 4 Days Week 96 · Yes	77 Participants	—

SECONDARY outcome

Timeframe: week 0, 48 and 96

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Quality of Life - General Health Outcome week 0 · Excellent	160 Participants	164 Participants
Quality of Life - General Health Outcome week 0 · Very good	262 Participants	269 Participants
Quality of Life - General Health Outcome week 0 · Good	327 Participants	333 Participants
Quality of Life - General Health Outcome week 0 · Fair	71 Participants	51 Participants
Quality of Life - General Health Outcome week 0 · Poor	3 Participants	1 Participants
Quality of Life - General Health Outcome week 48 · Excellent	172 Participants	185 Participants
Quality of Life - General Health Outcome week 48 · Very good	250 Participants	229 Participants
Quality of Life - General Health Outcome week 48 · Good	222 Participants	238 Participants
Quality of Life - General Health Outcome week 48 · Fair	52 Participants	48 Participants
Quality of Life - General Health Outcome week 48 · Poor	5 Participants	1 Participants
Quality of Life - General Health Outcome week 96 · Excellent	131 Participants	134 Participants
Quality of Life - General Health Outcome week 96 · Very good	179 Participants	178 Participants
Quality of Life - General Health Outcome week 96 · Good	165 Participants	157 Participants
Quality of Life - General Health Outcome week 96 · Fair	23 Participants	34 Participants
Quality of Life - General Health Outcome week 96 · Poor	2 Participants	1 Participants

SECONDARY outcome

Timeframe: week 0, 48 and 96

Population: All participants except one who was excluded as she withdrew from study on the day she was randomized

QoL - health rating score was evaluated by a self reported questionnaire. Health rating score of 0 was indicative of death or worst possible health and a score of 100 was being in perfect or best possible health and the mean of score is calculated. Higher scores indicate better Quality of Life (QoL). The range is 0-100 units on a scale

Outcome measures

Outcome measures
Measure	Continue HAART n=827 Participants Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.	Stop HAART n=825 Participants Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Quality of Life (QoL) - Health Rating Score week 0	82.7 units on a scale Standard Deviation 15.7	83.0 units on a scale Standard Deviation 15.1
Quality of Life (QoL) - Health Rating Score week 48	85.3 units on a scale Standard Deviation 14.7	85.4 units on a scale Standard Deviation 14.0
Quality of Life (QoL) - Health Rating Score week 96	86.2 units on a scale Standard Deviation 14.1	86.3 units on a scale Standard Deviation 14.0

SECONDARY outcome

Timeframe: Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.

This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).

Population: This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.

This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.

Outcome measures

Outcome data not reported

Adverse Events

Continue HAART

Serious events: 10 serious events

Other events: 778 other events

Deaths: 2 deaths

Stop HAART

Serious events: 3 serious events

Other events: 765 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Continue HAART n=827 participants at risk Participants would continue receiving HAART after delivery or other pregnancy outcome. Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes	Stop HAART n=825 participants at risk Participants would stop receiving HAART after delivery or other pregnancy outcome and resume when protocol-specified criteria were met. Highly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes
Infections and infestations Endophthalmitis	0.00% 0/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.12% 1/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Infections and infestations Pelvic inflammatory disease	0.12% 1/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.00% 0/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Injury, poisoning and procedural complications Ergot poisoning	0.12% 1/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.00% 0/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.24% 2/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.00% 0/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.12% 1/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.00% 0/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Pregnancy, puerperium and perinatal conditions Foetal death	0.24% 2/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.00% 0/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.24% 2/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.12% 1/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Psychiatric disorders Suicide attempt	0.00% 0/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.12% 1/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Surgical and medical procedures Abortion induced	0.12% 1/827 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.	0.00% 0/825 • From study entry to off study date (an average of 125 weeks of follow-up). The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \>=Grade 3 (with exceptions to all grades of creatinine and all grade \>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.

Other adverse events

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

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