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IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women

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ClinicalTrials.gov Identifier: NCT00955968
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : February 16, 2018
Last Update Posted : December 14, 2018
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Intervention Drug: Highly active antiretroviral therapy (HAART)
Enrollment 1653
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome. Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Period Title: Overall Study
Started 828 825
Completed 691 699
Not Completed 137 126
Reason Not Completed
Death             2             4
Withdrawal by Subject             35             31
Lost to Follow-up             45             39
Site closed             55             52
Arm/Group Title Continue HAART Stop HAART Total
Hide Arm/Group Description Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome. Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met. Total of all reporting groups
Overall Number of Baseline Participants 827 825 1652
Hide Baseline Analysis Population Description
All the participants who were randomized to the study with the exception of one participant who was excluded as she withdrew from the study on the day she was randomized
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 827 participants 825 participants 1652 participants
<=18 years
18
   2.2%
18
   2.2%
36
   2.2%
Between 18 and 65 years
809
  97.8%
807
  97.8%
1616
  97.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 827 participants 825 participants 1652 participants
27
(23 to 32)
28
(24 to 32)
28
(23 to 32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 827 participants 825 participants 1652 participants
Female
827
 100.0%
825
 100.0%
1652
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Haiti Number Analyzed 827 participants 825 participants 1652 participants
32
   3.9%
29
   3.5%
61
   3.7%
Argentina Number Analyzed 827 participants 825 participants 1652 participants
20
   2.4%
25
   3.0%
45
   2.7%
United States Number Analyzed 827 participants 825 participants 1652 participants
72
   8.7%
77
   9.3%
149
   9.0%
Botswana Number Analyzed 827 participants 825 participants 1652 participants
230
  27.8%
227
  27.5%
457
  27.7%
China Number Analyzed 827 participants 825 participants 1652 participants
52
   6.3%
52
   6.3%
104
   6.3%
Brazil Number Analyzed 827 participants 825 participants 1652 participants
259
  31.3%
255
  30.9%
514
  31.1%
Thailand Number Analyzed 827 participants 825 participants 1652 participants
156
  18.9%
151
  18.3%
307
  18.6%
Peru Number Analyzed 827 participants 825 participants 1652 participants
6
   0.7%
9
   1.1%
15
   0.9%
Race/Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 827 participants 825 participants 1652 participants
Asian
209
  25.3%
203
  24.6%
412
  24.9%
Black or African American
58
   7.0%
58
   7.0%
116
   7.0%
White
123
  14.9%
127
  15.4%
250
  15.1%
American Indian
1
   0.1%
1
   0.1%
2
   0.1%
Alaskan Native
0
   0.0%
1
   0.1%
1
   0.1%
Black African
230
  27.8%
227
  27.5%
457
  27.7%
Black of African origin
77
   9.3%
70
   8.5%
147
   8.9%
Mestizo
6
   0.7%
8
   1.0%
14
   0.8%
Mixed Black
73
   8.8%
76
   9.2%
149
   9.0%
Mixed native
0
   0.0%
4
   0.5%
4
   0.2%
Native (native Brazilian-Xavante/Kaigang/Guarani)
1
   0.1%
1
   0.1%
2
   0.1%
Other
31
   3.7%
31
   3.8%
62
   3.8%
Subject does not know
4
   0.5%
2
   0.2%
6
   0.4%
Race not available to clinic
14
   1.7%
16
   1.9%
30
   1.8%
Body Mass Index (BMI)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 812 participants 801 participants 1613 participants
24.4
(21.7 to 28.0)
24.6
(21.8 to 28.3)
24.5
(21.8 to 28.1)
[1]
Measure Analysis Population Description: Baseline weight and height measure were not completed for some participants
WHO stage at entry   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 827 participants 823 participants 1650 participants
Clinical Stage I
810
  97.9%
811
  98.5%
1621
  98.2%
Clinical Stage II
16
   1.9%
11
   1.3%
27
   1.6%
Clinical Stage III
1
   0.1%
1
   0.1%
2
   0.1%
[1]
Measure Description: Clinical staging of HIV/AIDS by WHO definitions (WHO, 2007). Staging is based on clinical findings that guide the diagnosis, evaluation, and management of HIV/AIDS. Clinical stages are categorized as 1 through 4, progressing from primary HIV infection to advanced HIV/AIDS. These stages are defined by specific clinical conditions or symptoms as described in the reference (see the References in the Protocol Section).
[2]
Measure Analysis Population Description: Baseline WHO staging criteria was not completed for some participants.
Duration of Antiretroviral therapy (ART) prior to study entry  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 827 participants 825 participants 1652 participants
17
(11 to 23)
17
(11 to 23)
17
(11 to 23)
ART regimen prior to entry   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
HAART including boosted PI Number Analyzed 827 participants 825 participants 1652 participants
629
  76.1%
612
  74.2%
1241
  75.1%
HAART including non-boosted PI Number Analyzed 827 participants 825 participants 1652 participants
12
   1.5%
16
   1.9%
28
   1.7%
HAART including NNRTI [EFV] Number Analyzed 827 participants 825 participants 1652 participants
180
  21.8%
172
  20.8%
352
  21.3%
HAART including NNRTI [NVP] Number Analyzed 827 participants 825 participants 1652 participants
4
   0.5%
8
   1.0%
12
   0.7%
HAART including NNRTI [RPV] Number Analyzed 827 participants 825 participants 1652 participants
1
   0.1%
1
   0.1%
2
   0.1%
HAART including NNRTI and PI Number Analyzed 827 participants 825 participants 1652 participants
1
   0.1%
0
   0.0%
1
   0.1%
Three or more NRTIs Number Analyzed 827 participants 825 participants 1652 participants
3
   0.4%
11
   1.3%
14
   0.8%
Zero NRTIs Number Analyzed 827 participants 825 participants 1652 participants
0
   0.0%
1
   0.1%
1
   0.1%
HAART including II Number Analyzed 827 participants 825 participants 1652 participants
4
   0.5%
4
   0.5%
8
   0.5%
HAART including PI and II Number Analyzed 827 participants 825 participants 1652 participants
2
   0.2%
0
   0.0%
2
   0.1%
[1]
Measure Description: PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, EFV - Efavirenz, NVP - Nevirapine, RPV - Rilpivirine, NRTI - Nucleoside Reverse Transcriptase Inhibitor, II - Integrase Inhibitor
Hepatitis B surface antigen   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Positive Number Analyzed 821 participants 819 participants 1640 participants
29
   3.5%
28
   3.4%
57
   3.5%
Negative Number Analyzed 821 participants 819 participants 1640 participants
771
  93.9%
768
  93.8%
1539
  93.8%
Indeterminate Number Analyzed 821 participants 819 participants 1640 participants
1
   0.1%
0
   0.0%
1
   0.1%
Not obtained, Hep B antibody +ve Number Analyzed 821 participants 819 participants 1640 participants
20
   2.4%
23
   2.8%
43
   2.6%
[1]
Measure Analysis Population Description: Baseline Hepatitis B surface antigen was not obtained for some participants
Hepatitis B surface antibody   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Positive Number Analyzed 826 participants 823 participants 1649 participants
263
  31.8%
248
  30.1%
511
  31.0%
Negative Number Analyzed 826 participants 823 participants 1649 participants
424
  51.3%
425
  51.6%
849
  51.5%
Indeterminate Number Analyzed 826 participants 823 participants 1649 participants
1
   0.1%
2
   0.2%
3
   0.2%
Not obtained, Hep B antibody +ve Number Analyzed 826 participants 823 participants 1649 participants
138
  16.7%
148
  18.0%
286
  17.3%
[1]
Measure Analysis Population Description: Baseline Hepatitis B surface antibody was not obtained for some participants
CD4+ cell count on ART   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 827 participants 825 participants 1652 participants
696
(575 to 870)
695
(575 to 868)
696
(575 to 869)
[1]
Measure Description: CD4+ cell count was evaluated at screening
Pre-ART CD4+ cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 827 participants 825 participants 1652 participants
550
(461 to 682)
548
(463 to 677)
549
(462 to 680)
Plasma HIV Viral Load   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
< 400 copies/ml Number Analyzed 822 participants 819 participants 1641 participants
744
  90.5%
742
  90.6%
1486
  90.6%
400 - <1000 copies/ml Number Analyzed 822 participants 819 participants 1641 participants
30
   3.6%
24
   2.9%
54
   3.3%
1000- <10000 copies/ml Number Analyzed 822 participants 819 participants 1641 participants
32
   3.9%
29
   3.5%
61
   3.7%
10000-<100000 copies/ml Number Analyzed 822 participants 819 participants 1641 participants
15
   1.8%
24
   2.9%
39
   2.4%
>=100000 copies/ml Number Analyzed 822 participants 819 participants 1641 participants
1
   0.1%
0
   0.0%
1
   0.1%
[1]
Measure Analysis Population Description: Baseline Plasma HIV viral load was not obtained for some participants
1.Primary Outcome
Title Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
0.21
(0.16 to 0.27)
0.31
(0.25 to 0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Stop HAART
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments 5% alpha level and 2-sided test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.19 to 2.40
Estimation Comments HR reflects Continue HAART : Stop HAART
2.Secondary Outcome
Title Incidence Rate of AIDS - Defining Illness
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
0.10
(0.08 to 0.14)
0.15
(0.12 to 0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Stop HAART
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments 5% alpha level and 2-sided test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.11 to 4.01
Estimation Comments HR reflects Continue HAART : Stop HAART
3.Secondary Outcome
Title Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
0
(0 to 0)
0
(0 to 0)
4.Secondary Outcome
Title Incidence Rate of Deaths
Hide Description The incidence rate was obtained by using the Kaplan-Meier method.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
0.10
(0.08 to 0.14)
0.20
(0.17 to 0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Stop HAART
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments 5% alpha level and 2-sided test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.09 to 2.81
Estimation Comments HR reflects Continue HAART : Stop HAART
5.Secondary Outcome
Title Incidence Rate of HIV/AIDS Related Events
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
1.32
(1.07 to 1.62)
1.42
(1.16 to 1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Stop HAART
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments 5% alpha level and 2-sided test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.54 to 1.60
Estimation Comments HR reflects Continue HAART : Stop HAART
6.Secondary Outcome
Title Incidence Rate of HIV/AIDS Related Events or Death
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
1.42
(1.16 to 1.75)
1.57
(1.30 to 1.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Stop HAART
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments 5% alpha level and 2-sided test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.54 to 1.52
Estimation Comments HR reflects Continue HAART : Stop HAART
7.Secondary Outcome
Title Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.
Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.
Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
3.09
(2.52 to 3.79)
5.37
(4.60 to 6.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Stop HAART
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 5% alpha level and 2-sided test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.42 to 0.80
Estimation Comments HR reflects Continue HAART : Stop HAART
8.Secondary Outcome
Title Incidence Rate of Grade 2 and Above Toxicity
Hide Description 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.
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants except one who was excluded as she withdrew from study on the day she was randomized
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:

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

Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART 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

Overall Number of Participants Analyzed 827 825
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: New cases per 100 person - years
18.4
(15.7 to 21.4)
15.6
(13.2 to 18.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continue HAART, Stop HAART
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments 5% alpha level and 2-sided test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.72 to 1.03
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Incidence Rate of Cardiovascular or Other Metabolic Events
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
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Hide Analysis Population Description
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.
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:

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

Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Incidence Rate of Other Targeted Medical Conditions
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:

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

Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death
Hide Description 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.
Time Frame From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:

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

Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm
Hide Description 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)
Time Frame 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.
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Hide Analysis Population Description
156 women who were VFs had antiretroviral drug resistance testing performed.
Arm/Group Title Continue HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome
Overall Number of Participants Analyzed 156
Measure Type: Count of Participants
Unit of Measure: Participants
19
  12.2%
13.Secondary Outcome
Title Medication Adherence - Last Time Missed Medications
Hide Description Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Time Frame week 0, 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Continue HAART arm who had evaluations done at the respective weeks
Arm/Group Title Continue HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome
Overall Number of Participants Analyzed 672
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 672 participants
Never skipped medications
489
  72.8%
More than 1 month ago
60
   8.9%
Within the past 4 weeks
123
  18.3%
Week 48 Number Analyzed 652 participants
Never skipped medications
411
  63.0%
More than 1 month ago
97
  14.9%
Within the past 4 weeks
144
  22.1%
Week 96 Number Analyzed 638 participants
Never skipped medications
399
  62.5%
More than 1 month ago
92
  14.4%
Within the past 4 weeks
147
  23.0%
14.Secondary Outcome
Title Medication Adherence - How Closely Followed Schedule
Hide Description Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Time Frame week 0, 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Continue HAART arm who had evaluations done at the respective weeks
Arm/Group Title Continue HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome
Overall Number of Participants Analyzed 673
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 673 participants
Never
23
   3.4%
Some of the time
130
  19.3%
All of the time
520
  77.3%
Week 48 Number Analyzed 651 participants
Never
17
   2.6%
Some of the time
173
  26.6%
All of the time
461
  70.8%
Week 96 Number Analyzed 637 participants
Never
25
   3.9%
Some of the time
153
  24.0%
All of the time
459
  72.1%
15.Secondary Outcome
Title Medication Adherence - How Often Follow Instructions
Hide Description Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Time Frame week 0, 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Continue HAART arm who had evaluations done at the respective weeks
Arm/Group Title Continue HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome
Overall Number of Participants Analyzed 667
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 667 participants
Never
10
   1.5%
Some of the time
52
   7.8%
All of the time
166
  24.9%
No special instructions
439
  65.8%
Week 48 Number Analyzed 650 participants
Never
6
   0.9%
Some of the time
61
   9.4%
All of the time
194
  29.8%
No special instructions
389
  59.8%
Week 96 Number Analyzed 637 participants
Never
8
   1.3%
Some of the time
74
  11.6%
All of the time
190
  29.8%
No special instructions
365
  57.3%
16.Secondary Outcome
Title Medication Adherence - Missed Dose Within Past 4 Days
Hide Description Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.
Time Frame week 0, 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Continue HAART arm who had evaluations done at the respective weeks
Arm/Group Title Continue HAART
Hide Arm/Group Description:
Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome
Overall Number of Participants Analyzed 653
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 653 participants
No
592
  90.7%
Yes
61
   9.3%
Week 48 Number Analyzed 635 participants
No
564
  88.8%
Yes
71
  11.2%
Week 96 Number Analyzed 621 participants
No
544
  87.6%
Yes
77
  12.4%
17.Secondary Outcome
Title Quality of Life
Hide Description This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. The analyses are planned to be completed by October 2019, after which results will be reported to ct.gov.
Time Frame 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).
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers
Hide Description 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.
Time Frame 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:

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

Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Cost Effectiveness and Feasibility of Treatment Models
Hide Description 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.
Time Frame 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description:

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

Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From study entry to off study date (an average of 125 weeks of follow-up).
Adverse Event Reporting Description 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.
 
Arm/Group Title Continue HAART Stop HAART
Hide Arm/Group Description

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

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

All-Cause Mortality
Continue HAART Stop HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   2/827 (0.24%)   4/825 (0.48%) 
Show Serious Adverse Events Hide Serious Adverse Events
Continue HAART Stop HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   10/827 (1.21%)   3/825 (0.36%) 
Infections and infestations     
Endophthalmitis  1  0/827 (0.00%)  1/825 (0.12%) 
Pelvic inflammatory disease  1  1/827 (0.12%)  0/825 (0.00%) 
Injury, poisoning and procedural complications     
Ergot poisoning  1  1/827 (0.12%)  0/825 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion incomplete  1  2/827 (0.24%)  0/825 (0.00%) 
Abortion spontaneous  1  1/827 (0.12%)  0/825 (0.00%) 
Foetal death  1  2/827 (0.24%)  0/825 (0.00%) 
Stillbirth  1  2/827 (0.24%)  1/825 (0.12%) 
Psychiatric disorders     
Suicide attempt  1  0/827 (0.00%)  1/825 (0.12%) 
Surgical and medical procedures     
Abortion induced  1  1/827 (0.12%)  0/825 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Continue HAART Stop HAART
Affected / at Risk (%) Affected / at Risk (%)
Total   778/827 (94.07%)   765/825 (92.73%) 
Gastrointestinal disorders     
Diarrhoea  1  65/827 (7.86%)  38/825 (4.61%) 
Nausea  1  54/827 (6.53%)  48/825 (5.82%) 
Vomiting  1  46/827 (5.56%)  37/825 (4.48%) 
Infections and infestations     
Acute sinusitis  1  31/827 (3.75%)  60/825 (7.27%) 
Bacterial vaginosis  1  62/827 (7.50%)  67/825 (8.12%) 
Cervicitis  1  62/827 (7.50%)  48/825 (5.82%) 
Tonsillitis  1  50/827 (6.05%)  71/825 (8.61%) 
Urinary tract infection  1  37/827 (4.47%)  48/825 (5.82%) 
Viral upper respiratory tract infection  1  60/827 (7.26%)  53/825 (6.42%) 
Vulvovaginal candidiasis  1  58/827 (7.01%)  97/825 (11.76%) 
Investigations     
Alanine aminotransferase increased  1  70/827 (8.46%)  71/825 (8.61%) 
Aspartate aminotransferase increased  1  51/827 (6.17%)  44/825 (5.33%) 
Blood bicarbonate decreased  1  49/827 (5.93%)  61/825 (7.39%) 
Blood bilirubin increased  1  148/827 (17.90%)  57/825 (6.91%) 
Blood cholesterol increased  1  527/827 (63.72%)  500/825 (60.61%) 
Blood glucose abnormal  1  58/827 (7.01%)  51/825 (6.18%) 
Blood glucose decreased  1  121/827 (14.63%)  91/825 (11.03%) 
Blood glucose increased  1  117/827 (14.15%)  123/825 (14.91%) 
Blood phosphorus decreased  1  103/827 (12.45%)  76/825 (9.21%) 
Blood sodium decreased  1  88/827 (10.64%)  100/825 (12.12%) 
Haemoglobin decreased  1  68/827 (8.22%)  63/825 (7.64%) 
Low density lipoprotein increased  1  459/827 (55.50%)  427/825 (51.76%) 
Neutrophil count decreased  1  87/827 (10.52%)  88/825 (10.67%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  183/827 (22.13%)  176/825 (21.33%) 
Reproductive system and breast disorders     
Cervical dysplasia  1  94/827 (11.37%)  118/825 (14.30%) 
Vascular disorders     
Hypertension  1  42/827 (5.08%)  36/825 (4.36%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
Publications:
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 with Clarification dated August 2009, which can be found on the DAIDS RSC Web site: http://rsc.tech-res.com
Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0, January 2010.
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00955968     History of Changes
Other Study ID Numbers: IMPAACT 1077HS
U01AI068632 ( U.S. NIH Grant/Contract )
First Submitted: August 7, 2009
First Posted: August 10, 2009
Results First Submitted: August 30, 2017
Results First Posted: February 16, 2018
Last Update Posted: December 14, 2018