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Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries (PROMISE)

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ClinicalTrials.gov Identifier: NCT01061151
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Drug: Zidovudine (ZDV)
Drug: Nevirapine (NVP): Antepartum Mothers
Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
Drug: Lamivudine-Zidovudine (3TC-ZDV)
Drug: Lopinavir-ritonavir (LPV-RTV)
Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV])
Drug: Nevirapine (NVP): Infant short-course
Drug: Nevirapine (NVP): Infant extended
Other: No Intervention
Other: Discontinue triple ARVs
Other: Continue triple ARVs

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Antepartum Arm A Mothers received ZDV+sdNVP+TRV tail
Antepartum Arm B Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
Antepartum Arm C Mothers received Triple ARV (FTC-TDF/LPV-RTV)
Late Presenters Registrational component to assess entry criteria for possible randomization in the Postpartum Component

Participant Flow for 2 periods

Period 1:   Protocol Version 2.0: 04/2011-09/2012
    Antepartum Arm A   Antepartum Arm B   Antepartum Arm C   Late Presenters
STARTED   855   861   25   129 
Mothers That Met All Inclusion Criteria   853   861   24   129 
COMPLETED   623   620   16   101 
NOT COMPLETED   232   241   9   28 
Protocol Violation                2                0                0                1 
Death                6                9                1                2 
Withdrawal by Subject                89                82                2                10 
Lost to Follow-up                73                65                2                10 
Site Closure                15                19                1                0 
Subject Unable to Get to Clinic                44                61                2                5 
Other Reason                3                5                1                0 

Period 2:   Protocol Version 3.0: 10/2012-10/2014
    Antepartum Arm A   Antepartum Arm B   Antepartum Arm C   Late Presenters
STARTED   694   686   422   75 
Mothers That Met All Inclusion Criteria   694   684   421   75 
COMPLETED   542   548   345   55 
NOT COMPLETED   152   138   77   20 
Protocol Violation                0                0                2                4 
Adverse Event                1                0                0                0 
Death                3                5                1                1 
Withdrawal by Subject                54                52                31                3 
Lost to Follow-up                49                36                25                4 
Site Closure                12                11                2                0 
Subject Unable to Get to Clinic                28                26                15                5 
Other Reason                5                8                1                3 



  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.
No text entered.

Reporting Groups
  Description
Antepartum Arm A Mothers received ZDV+sdNVP+TRV tail
Antepartum Arm B Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
Antepartum Arm C Mothers received Triple ARV (FTC-TDF/LPV-RTV)
Late Presenters Registrational component to assess entry criteria for possible randomization in the Postpartum Component
Total Total of all reporting groups

Baseline Measures
   Antepartum Arm A   Antepartum Arm B   Antepartum Arm C   Late Presenters   Total 
Overall Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Age 
[Units: Years]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
   26.5 
 (22.8 to 30.1) 
 26.6 
 (23.3 to 30.3) 
 26.4 
 (22.7 to 30.4) 
 26.8 
 (23.2 to 31.1) 
 26.5 
 (23.0 to 30.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Female      1547 100.0%      1545 100.0%      445 100.0%      204 100.0%      3741 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
Black Non-Hispanic           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Black Non-Hispanic   1493   1487   440   183   3603 
Hispanic (Regardless of Race)           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Hispanic (Regardless of Race)   7   12   4   2   25 
Asian, Pacific Islander           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Asian, Pacific Islander   47   46   1   19   113 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
Malawi           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Malawi   489   493   155   31   1168 
Tanzania           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Tanzania   23   24   10   0   57 
South Africa           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
South Africa   513   510   78   27   1128 
Uganda           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Uganda   207   205   85   9   506 
Zimbabwe           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Zimbabwe   237   236   99   116   688 
Zambia           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
Zambia   32   31   18   2   83 
India           
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
India   46   46   0   19   111 
Weight [1] 
[Units: Kg]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   200   3737 
   64 
 (57.5 to 73.5) 
 64.6 
 (58 to 74.1) 
 64.4 
 (58 to 75.9) 
 60.9 
 (53 to 68.9) 
 64 
 (57.5 to 74) 
[1] Some late presenters had incomplete measurements
BMI [1] 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1545   1535   442   198   3720 
   25.9 
 (23.5 to 29.5) 
 26.3 
 (23.4 to 29.8) 
 26.3 
 (23.5 to 30.1) 
 23.6 
 (21.8 to 26.8) 
 26 
 (23.4 to 29.6) 
[1] Some participants had incomplete measurements for either weight, height, or both.
HIV RNA level prior to randomization [1] 
[Units: Copies/ml]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1540   1542   445   196   3723 
   6409 
 (1450.5 to 22720) 
 8002 
 (1854 to 28767) 
 8393 
 (1909 to 28454) 
 12140 
 (2407.5 to 39138.5) 
 7409 
 (1708 to 26350) 
[1] Baseline HIV RNA data was incomplete for some participants.
Viral Load at enrollment [1] 
[Units: Log10 copies/mL]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1540   1542   445   196   3723 
   3.8 
 (3.2 to 4.4) 
 3.9 
 (3.3 to 4.5) 
 3.9 
 (3.3 to 4.5) 
 4.1 
 (3.4 to 4.6) 
 3.9 
 (3.2 to 4.4) 
[1] Baseline HIV RNA data was incomplete for some participants.
CD4 count at screening 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
   534 
 (435 to 678) 
 526 
 (439 to 651) 
 538 
 (434 to 684) 
 520 
 (353 to 723) 
 530 
 (434 to 670) 
ALT (SGPT) [1] 
[Units: Units/liter]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   196   3733 
   12 
 (10 to 16) 
 12 
 (9 to 15) 
 12 
 (9 to 15) 
 16.5 
 (12 to 22) 
 12 
 (10 to 16) 
[1] Baseline Alanine Aminotransferase (ALT) values were incomplete for some late presenters.
Hemoglobin 
[Units: G/dl]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   204   3741 
   11 
 (10.2 to 11.8) 
 11.1 
 (10.3 to 11.8) 
 11 
 (10.3 to 11.8) 
 10.6 
 (9.5 to 11.7) 
 11 
 (10.2 to 11.8) 
WBC [1] 
[Units: (cells/mm^3)]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   196   3733 
   6800 
 (5670 to 8200) 
 6900 
 (5700 to 8200) 
 6840 
 (5700 to 7900) 
 8660 
 (6895 to 10755) 
 6900 
 (5700 to 8250) 
[1] Baseline White Blood Cell (WBC) values were incomplete for some participants.
Absolute Neutrophil Count at Baseline [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   196   3733 
   4140 
 (3250 to 5360) 
 4209 
 (3297 to 5300) 
 3990 
 (3220 to 4990) 
 5680 
 (4342.5 to 7662.5) 
 4220 
 (3297 to 5400) 
[1] Baseline Absolute Neutrophil Count (ANC) values were incomplete for some participants.
Platelet count [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1544   444   195   3730 
   238000 
 (200000 to 282000) 
 236000 
 (196000 to 282000) 
 242500 
 (203000 to 290000) 
 255000 
 (217000 to 321000) 
 239000 
 (200000 to 285000) 
[1] Baseline platelet counts were incomplete for some participants.
Serum Creatinine [1] 
[Units: mg/dL]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   199   3736 
   0.5 
 (0.4 to 0.6) 
 0.5 
 (0.4 to 0.6) 
 0.5 
 (0.4 to 0.6) 
 0.6 
 (0.5 to 0.6) 
 0.5 
 (0.4 to 0.6) 
[1] Baseline Serum Creatinine values were incomplete for some participants.
WHO Clinical Staging of HIV/AIDS [1] [2] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 1544   1542   445   169   3700 
Clinical stage I      1493  96.7%      1506  97.7%      434  97.5%      165  97.6%      3598  97.2% 
Clinical stage II      50   3.2%      34   2.2%      11   2.5%      4   2.4%      99   2.7% 
Clinical stage III      1   0.1%      2   0.1%      0   0.0%      0   0.0%      3   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.
[2] Baseline WHO staging category was incomplete for some participants.
Calculated Creatinine Clearance (ml/min) [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 1547   1545   445   199   3736 
<= 50 ml/min      0   0.0%      0   0.0%      0   0.0%      1   0.5%      1   0.0% 
> 50 - 60 ml/min      1   0.1%      0   0.0%      1   0.2%      1   0.5%      3   0.1% 
> 60 - 80 ml/min      5   0.3%      5   0.3%      2   0.4%      2   1.0%      14   0.4% 
> 80 - 100 ml/min      27   1.7%      31   2.0%      6   1.3%      10   5.0%      74   2.0% 
> 100 - 120 ml/min      90   5.8%      108   7.0%      39   8.8%      31  15.6%      268   7.2% 
> 120 ml/min      1424  92.0%      1401  90.7%      397  89.2%      154  77.4%      3376  90.4% 
[1] Baseline Calculated Creatinine Clearance values were incomplete for some participants
Gestational age at study entry (weeks) [1] 
[Units: Weeks]
Median (Inter-Quartile Range)
         
Participants Analyzed 
[Units: Participants]
 1547   1544   445   194   3730 
   25.7 
 (20.9 to 30.3) 
 25.2 
 (20.6 to 30.1) 
 26 
 (21.9 to 31.1) 
 38.6 
 (37.3 to 40) 
 25.6 
 (21.1 to 30.4) 
[1] Baseline gestational age was incomplete for some participants.
Gestational age at study entry [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 1547   1544   445   10   3546 
<14 weeks      10   0.6%      8   0.5%      2   0.4%      0   0.0%      20   0.6% 
14 - <28 weeks      956  61.8%      1008  65.3%      264  59.3%      0   0.0%      2228  62.8% 
28 - <34 weeks      418  27.0%      368  23.8%      116  26.1%      1  10.0%      903  25.5% 
34 - < 37 weeks      117   7.6%      113   7.3%      45  10.1%      0   0.0%      275   7.8% 
>= 37 weeks      46   3.0%      47   3.0%      18   4.0%      9  90.0%      120   3.4% 
[1] Baseline gestational age was incomplete for some participants.
The Most Complex ARV Regimen for Prior PMTCT [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 1539   1544   445   204   3732 
HAART including NNRTI      7   0.5%      5   0.3%      2   0.4%      0   0.0%      14   0.4% 
sdNVP+ZDV      33   2.1%      48   3.1%      6   1.3%      0   0.0%      87   2.3% 
sdNVP      41   2.7%      46   3.0%      15   3.4%      2   1.0%      104   2.8% 
One PI      0   0.0%      1   0.1%      0   0.0%      0   0.0%      1   0.0% 
One NRTI      2   0.1%      2   0.1%      0   0.0%      0   0.0%      4   0.1% 
No ARVs for prior PMTCT/no prior pregnancy      1456  94.6%      1442  93.4%      422  94.8%      202  99.0%      3522  94.4% 
[1]

Baseline ARV history data were incomplete for some participants.

PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor

The Last ARV Regimen before Entry during the Current Pregnancy [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 1539   1544   445   204   3732 
HAART including NNRTI      1   0.1%      1   0.1%      0   0.0%      7   3.4%      9   0.2% 
Two NRTIs      2   0.1%      5   0.3%      3   0.7%      10   4.9%      20   0.5% 
sdNVP+ZDV      2   0.1%      0   0.0%      0   0.0%      1   0.5%      3   0.1% 
sdNVP      5   0.3%      2   0.1%      0   0.0%      33  16.2%      40   1.1% 
One NRTI      326  21.2%      336  21.8%      125  28.1%      0   0.0%      787  21.1% 
No ARVs during the current pregnancy      1203  78.2%      1200  77.7%      317  71.2%      153  75.0%      2873  77.0% 
[1]

Baseline ARV history data were incomplete for some participants.

NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine



  Outcome Measures

1.  Primary:   Antepartum Component: Number of Confirmed Infant HIV Infections   [ Time Frame: Measured at birth or Week 1 study visit ]

2.  Primary:   Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events   [ Time Frame: Measured through the Week 1 postpartum study visit ]

3.  Primary:   Antepartum Component: Number of Mothers With Obstetrical Complications   [ Time Frame: Measured through the Week 1 postpartum study visit ]

4.  Primary:   Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)   [ Time Frame: Measured at birth ]

5.  Primary:   Postpartum Component: Incidence of Confirmed Infant HIV Infection   [ Time Frame: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first ]

6.  Primary:   Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events   [ Time Frame: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first ]

7.  Primary:   Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

8.  Secondary:   Antepartum Component: Number of Infant HIV Infections   [ Time Frame: Measured at the birth (<= 3 days postpartum) visit ]

9.  Secondary:   Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery   [ Time Frame: Measured at the time of delivery ]

10.  Secondary:   Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery   [ Time Frame: Measured through 24 months post-delivery ]

11.  Secondary:   Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery   [ Time Frame: Measured at 12 and 24 months post-delivery ]

12.  Secondary:   Maternal Health Component: Incidence of Death   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

13.  Secondary:   Maternal Health Component: Incidence of AIDS-defining Illness   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

14.  Secondary:   Maternal Health Component: Incidence of HIV/AIDS-related Events   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

15.  Secondary:   Maternal Health Component: Incidence of HIV/AIDS-related Event or Death   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

16.  Secondary:   Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

17.  Secondary:   Maternal Health Component: Incidence of Tuberculosis   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

18.  Secondary:   Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results   [ Time Frame: From study entry until July 7, 2015, an average of 94 weeks of follow-up. ]

19.  Secondary:   Antepartum Component: Overall and HIV-free Infant Survival Through 24 Months of Age (in Conjunction With Infants in the Postpartum Component)   [ Time Frame: Measured through 24 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

20.  Secondary:   Antepartum Component: Adherence to the Maternal Antiretroviral (ARV) Regimen, as Measured by Maternal Report   [ Time Frame: Measured through the Week 1 postpartum study visit ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

21.  Secondary:   Antepartum Component: Maternal and Infant Viral Resistance to the Maternal and Infant ARV Strategies   [ Time Frame: Measured at the end of the 5-year study period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

22.  Secondary:   Antepartum Component: Cost Effectiveness and Feasibility of the Trial ARV Regimens   [ Time Frame: Measured at the end of the 5-year study period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

23.  Secondary:   Antepartum Component: Antepartum Change in HBV DNA Viral Load Between Week 8 and Baseline Levels (Using Log HBV DNA) Among Women With Detectable HBV DNA Viral Loads at Baseline and Other HBV Outcome Measures   [ Time Frame: Measured at Week 8 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

24.  Secondary:   Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures   [ Time Frame: Measured through complete cessation of breastfeeding or 18 months of age, whichever comes first ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

25.  Secondary:   Postpartum Component: Rates and Patterns of Maternal and Infant Resistance to the Maternal and Infant ARV Regimens   [ Time Frame: Measured at the end of the 5-year study period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

26.  Secondary:   Postpartum Component: Cost-effectiveness and Feasibility of the Study ARV Prophylaxis Regimens   [ Time Frame: Measured at the end of the 5-year study period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

27.  Secondary:   Postpartum Component: Pharmacokinetic Parameters of ARV Drugs Measured in Maternal Plasma, Hair, Breast Milk, and Infant Blood (Plasma or Dried Blood Spot) Samples Collected at Birth; Weeks 1, 6, 14, and 26; and Subsequent Visits During Breastfeeding   [ Time Frame: Measured through the last study visit during breastfeeding, or 18 months postpartum, whichever comes first ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

28.  Secondary:   Postpartum Component: Functional Maternal Antibody and HIV-envelope Binding Responses in Breast Milk and Plasma, Until Cessation of Breastfeeding or 18 Months Postpartum, Whichever Comes First   [ Time Frame: Measured through the time of cessation of breastfeeding or 18 months postpartum, whichever comes first ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

29.  Secondary:   Maternal Health Component: Composite Endpoint of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

30.  Secondary:   Maternal Health Component: Number of Cardiovascular or Other Metabolic Events   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

31.  Secondary:   Maternal Health Component: Other Targeted Medical Conditions   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

32.  Secondary:   Maternal Health Component: Composite Endpoint of Any Condition Outlined in Appendix IV of the Protocol or Death   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

33.  Secondary:   Maternal Health Component: Viral Resistance   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

34.  Secondary:   Maternal Health Component: Self-reported Adherence   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

35.  Secondary:   Maternal Health Component: Quality of Life   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

36.  Secondary:   Maternal Health Component: Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

37.  Secondary:   Maternal Health Component: Cost-effectiveness   [ Time Frame: From study entry until July 7, 2015. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 of Results:
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. [Updated August 2009]. Available from: http://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf
WHO Case Definitions of HIV for Surveillance and Revised Clinical Staging and Immunological Classification of HIV-related Disease in Adults and Children, World Health Organization, 2007. Available: http://apps.who.int/iris/handle/10665/43699

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

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01061151     History of Changes
Obsolete Identifiers: NCT01253538
Other Study ID Numbers: 1077BF (PROMISE)
10777 ( Registry Identifier: DAIDS ES )
IMPAACT 1077BF
First Submitted: February 1, 2010
First Posted: February 2, 2010
Results First Submitted: September 28, 2017
Results First Posted: February 9, 2018
Last Update Posted: February 9, 2018