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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 : August 7, 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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Continue HAART   Stop HAART
STARTED   828   825 
COMPLETED   691   699 
NOT COMPLETED   137   126 
Death                2                4 
Withdrawal by Subject                35                31 
Lost to Follow-up                45                39 
Site closed                55                52 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Continue HAART   Stop HAART   Total 
Overall Participants Analyzed 
[Units: Participants]
 827   825   1652 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed   827   825   1652 
<=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 
[Units: Years]
Median (Inter-Quartile Range)
     
Participants Analyzed   827   825   1652 
   27 
 (23 to 32) 
 28 
 (24 to 32) 
 28 
 (23 to 32) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   827   825   1652 
Female      827 100.0%      825 100.0%      1652 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Haiti       
Participants Analyzed   827   825   1652 
Haiti   32   29   61 
Argentina       
Participants Analyzed   827   825   1652 
Argentina   20   25   45 
United States       
Participants Analyzed   827   825   1652 
United States   72   77   149 
Botswana       
Participants Analyzed   827   825   1652 
Botswana   230   227   457 
China       
Participants Analyzed   827   825   1652 
China   52   52   104 
Brazil       
Participants Analyzed   827   825   1652 
Brazil   259   255   514 
Thailand       
Participants Analyzed   827   825   1652 
Thailand   156   151   307 
Peru       
Participants Analyzed   827   825   1652 
Peru   6   9   15 
Race/Ethnicity 
[Units: Participants]
Count of Participants
     
Participants Analyzed   827   825   1652 
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] 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
     
Participants Analyzed   812   801   1613 
   24.4 
 (21.7 to 28.0) 
 24.6 
 (21.8 to 28.3) 
 24.5 
 (21.8 to 28.1) 
[1] Baseline weight and height measure were not completed for some participants
WHO stage at entry [1] [2] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   827   823   1650 
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] 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] Baseline WHO staging criteria was not completed for some participants.
Duration of Antiretroviral therapy (ART) prior to study entry 
[Units: Weeks]
Median (Inter-Quartile Range)
     
Participants Analyzed   827   825   1652 
   17 
 (11 to 23) 
 17 
 (11 to 23) 
 17 
 (11 to 23) 
ART regimen prior to entry [1] 
[Units: Participants]
Count of Participants
     
HAART including boosted PI       
Participants Analyzed   827   825   1652 
HAART including boosted PI   629   612   1241 
HAART including non-boosted PI       
Participants Analyzed   827   825   1652 
HAART including non-boosted PI   12   16   28 
HAART including NNRTI [EFV]       
Participants Analyzed   827   825   1652 
HAART including NNRTI [EFV]   180   172   352 
HAART including NNRTI [NVP]       
Participants Analyzed   827   825   1652 
HAART including NNRTI [NVP]   4   8   12 
HAART including NNRTI [RPV]       
Participants Analyzed   827   825   1652 
HAART including NNRTI [RPV]   1   1   2 
HAART including NNRTI and PI       
Participants Analyzed   827   825   1652 
HAART including NNRTI and PI   1   0   1 
Three or more NRTIs       
Participants Analyzed   827   825   1652 
Three or more NRTIs   3   11   14 
Zero NRTIs       
Participants Analyzed   827   825   1652 
Zero NRTIs   0   1   1 
HAART including II       
Participants Analyzed   827   825   1652 
HAART including II   4   4   8 
HAART including PI and II       
Participants Analyzed   827   825   1652 
HAART including PI and II   2   0   2 
[1] 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] 
[Units: Participants]
Count of Participants
     
Positive       
Participants Analyzed   821   819   1640 
Positive   29   28   57 
Negative       
Participants Analyzed   821   819   1640 
Negative   771   768   1539 
Indeterminate       
Participants Analyzed   821   819   1640 
Indeterminate   1   0   1 
Not obtained, Hep B antibody +ve       
Participants Analyzed   821   819   1640 
Not obtained, Hep B antibody +ve   20   23   43 
[1] Baseline Hepatitis B surface antigen was not obtained for some participants
Hepatitis B surface antibody [1] 
[Units: Participants]
Count of Participants
     
Positive       
Participants Analyzed   826   823   1649 
Positive   263   248   511 
Negative       
Participants Analyzed   826   823   1649 
Negative   424   425   849 
Indeterminate       
Participants Analyzed   826   823   1649 
Indeterminate   1   2   3 
Not obtained, Hep B antibody +ve       
Participants Analyzed   826   823   1649 
Not obtained, Hep B antibody +ve   138   148   286 
[1] Baseline Hepatitis B surface antibody was not obtained for some participants
CD4+ cell count on ART [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
     
Participants Analyzed   827   825   1652 
   696 
 (575 to 870) 
 695 
 (575 to 868) 
 696 
 (575 to 869) 
[1] CD4+ cell count was evaluated at screening
Pre-ART CD4+ cell count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
     
Participants Analyzed   827   825   1652 
   550 
 (461 to 682) 
 548 
 (463 to 677) 
 549 
 (462 to 680) 
Plasma HIV Viral Load [1] 
[Units: Participants]
Count of Participants
     
< 400 copies/ml       
Participants Analyzed   822   819   1641 
< 400 copies/ml   744   742   1486 
400 - <1000 copies/ml       
Participants Analyzed   822   819   1641 
400 - <1000 copies/ml   30   24   54 
1000- <10000 copies/ml       
Participants Analyzed   822   819   1641 
1000- <10000 copies/ml   32   29   61 
10000-<100000 copies/ml       
Participants Analyzed   822   819   1641 
10000-<100000 copies/ml   15   24   39 
>=100000 copies/ml       
Participants Analyzed   822   819   1641 
>=100000 copies/ml   1   0   1 
[1] Baseline Plasma HIV viral load was not obtained for some participants


  Outcome Measures

1.  Primary:   Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

2.  Secondary:   Incidence Rate of AIDS - Defining Illness   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

3.  Secondary:   Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

4.  Secondary:   Incidence Rate of Deaths   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

5.  Secondary:   Incidence Rate of HIV/AIDS Related Events   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

6.  Secondary:   Incidence Rate of HIV/AIDS Related Events or Death   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

7.  Secondary:   Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

8.  Secondary:   Incidence Rate of Grade 2 and Above Toxicity   [ Time Frame: All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symtoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up) ]

9.  Secondary:   Incidence Rate of Cardiovascular or Other Metabolic Events   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

10.  Secondary:   Incidence Rate of Other Targeted Medical Conditions   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

11.  Secondary:   Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death   [ Time Frame: From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up). ]

12.  Secondary:   Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm   [ 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. ]

13.  Secondary:   Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers   [ 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). ]

14.  Secondary:   Cost Effectiveness and Feasibility of Treatment Models   [ 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). ]

15.  Secondary:   Medication Adherence   [ 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). ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  

16.  Secondary:   Quality of Life   [ 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). ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
phone: (919) 405-1429
e-mail: mallen@fhi360.org


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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: August 7, 2018