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Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02282293
Recruitment Status : Completed
First Posted : November 4, 2014
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Diana Havlir, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Malaria
Human Immunodeficiency Virus
Interventions Drug: Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS)
Drug: Monthly placebo + daily trimethoprim/sulfamethoxazole (TS)
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Period Title: Overall Study
Started 100 100
Completed 97 97
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             2             2
Unable to comply with study procedures             1             0
Moved out of study area             0             1
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy Total
Hide Arm/Group Description

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
30.3  (5.8) 29.8  (6.8) 30.1  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
100
 100.0%
100
 100.0%
200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
100
 100.0%
100
 100.0%
200
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Gestational age (cont)  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 100 participants 100 participants 200 participants
19.2  (4.1) 19.9  (4.5) 19.6  (4.3)
Gestational age (cat)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
12-16 wk
28
  28.0%
25
  25.0%
53
  26.5%
> 16-20 wk
30
  30.0%
26
  26.0%
56
  28.0%
> 20 - 24 wk
29
  29.0%
27
  27.0%
56
  28.0%
> 24 - 28 wk
13
  13.0%
22
  22.0%
35
  17.5%
Gravidity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
1 pregnancy
5
   5.0%
13
  13.0%
18
   9.0%
2 pregnancy
13
  13.0%
12
  12.0%
25
  12.5%
>= 3 pregnancies
82
  82.0%
75
  75.0%
157
  78.5%
Insecticide-treated bednet (ITN) ownership  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
57
  57.0%
57
  57.0%
114
  57.0%
Household Wealth  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Lowest Tertile
33
  33.0%
34
  34.0%
67
  33.5%
Middle Tertile
30
  30.0%
36
  36.0%
66
  33.0%
Highest Tertile
37
  37.0%
30
  30.0%
67
  33.5%
Receiving TMP-SMX prophylaxis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
90
  90.0%
91
  91.0%
181
  90.5%
Receiving ART  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
82
  82.0%
79
  79.0%
161
  80.5%
CD4+ T-cell count, cells/mm^3  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 100 participants 100 participants 200 participants
500
(392 to 622)
516
(368 to 660)
516
(372 to 638)
HIV load below limit of detection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
51
  51.0%
60
  60.0%
111
  55.5%
WHO HIV disease stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
WHO Stage 1
93
  93.0%
97
  97.0%
190
  95.0%
WHO Stage 2
4
   4.0%
1
   1.0%
5
   2.5%
WHO Stage 3
3
   3.0%
2
   2.0%
5
   2.5%
WHO Stage 4
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description:

WHO clinical staging of HIV/AIDS is defined in the following document: https://www.who.int/hiv/pub/guidelines/clinicalstaging.pdf

In brief:

Stage 1. Asymptomatic Stage 2. Minor infections or <10% weight loss Stage 3. TB, bacterial infections; systemic symptoms or laboratory values of chronic illness Stage 4. Opportunistic infections or cancers

Detection of malaria parasites by LAMP  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
11
  11.0%
6
   6.0%
17
   8.5%
1.Primary Outcome
Title Number of Participants With Placental Malaria
Hide Description The primary outcome will be the prevalence of placental malaria based on placental histopathology and dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence of placental infection.
Time Frame at delivery estimated to be within 10 to 30 weeks of study entry
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description:

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Overall Number of Participants Analyzed 96 98
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.1%
6
   6.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TS + DP Placebo Pregnancy, Daily TS + Monthly DP Pregnancy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments Calculated p-value
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
0.50 to 7.61
Estimation Comments [Not Specified]
2.Primary Outcome
Title Incidence of Malaria, Pregnant Women
Hide Description The primary outcome will be the incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days.
Time Frame Time at risk will begin following administration of first dose of study drug to delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description:

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: Events per person-year
0.03 0.00
3.Secondary Outcome
Title Maternal Parasitemia at Delivery by Microscopy and LAMP
Hide Description Proportion of women with parasitemia detected by microscopy or LAMP at delivery
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Out of all 100 enrolled women in each arm: two women in TS+Placebo arm did not have maternal blood specimens collected to analyze; One participant in Daily TS + Monthly DP pregnancy arm did not have blood slide completed for microscopy results but did have blood spot collected for LAMP analysis
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description:

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Overall Number of Participants Analyzed 98 100
Measure Type: Count of Participants
Unit of Measure: Participants
Microscopy Number Analyzed 98 participants 99 participants
0
   0.0%
1
   1.0%
LAMP Number Analyzed 98 participants 100 participants
2
   2.0%
4
   4.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TS + DP Placebo Pregnancy, Daily TS + Monthly DP Pregnancy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
0.50 to 7.61
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR)
Hide Description Proportion of placental blood samples positive for malaria by microscopy or PCR
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Out of all 100 enrolled women in each arm: four women in TS+Placebo arm and two women in TS+DP arm did not have placental blood specimens collected to analyze; One participant TS+Placebo arm did not have microscopy results; Only one placental blood specimen was collected for each woman
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description:

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Overall Number of Participants Analyzed 96 98
Measure Type: Count of Participants
Unit of Measure: Participants
Microscopy of placental blood Number Analyzed 95 participants 98 participants
0
   0.0%
1
   1.0%
LAMP analysis of placental blood Number Analyzed 96 participants 98 participants
1
   1.0%
3
   3.1%
5.Secondary Outcome
Title Number of Monthly Routine Visits With Positive Blood Samples for Parasites
Hide Description Proportion of monthly routine blood samples positive by LAMP for parasites
Time Frame Following administration of first dose of study drug to delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description:

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Overall Number of Participants Analyzed 100 100
Overall Number of Units Analyzed
Type of Units Analyzed: Visits with positive blood sample
392 368
Count of Units
Unit of Measure: visits with positive blood sample
12
   3.1%
5
   1.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TS + DP Placebo Pregnancy, Daily TS + Monthly DP Pregnancy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments Calculated p-value
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.13 to 1.48
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Composite Adverse Birth Outcome (Proportion With Low Birth Weight (<2500 gm), Spontaneous Abortion (<28 Weeks), Stillbirth (Fetal Demise ≥28 Weeks), Congenital Anomaly, or Preterm Delivery (<37 Weeks)
Hide Description Proportion with low birth weight (<2500 gm), spontaneous abortion (<28 weeks), stillbirth (fetal demise ≥28 weeks), congenital anomaly, or preterm delivery (<37 weeks)
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description:

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
15
  15.0%
20
  20.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TS + DP Placebo Pregnancy, Daily TS + Monthly DP Pregnancy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.72 to 2.45
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Routine Visits Measured Every 8 Weeks During Pregnancy for Which the Participants Had Anemia
Hide Description Anemia (hemoglobin less than 11g/dL) measured every 8 weeks during pregnancy
Time Frame Following administration of first dose of study drugs to delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description:

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

Overall Number of Participants Analyzed 100 100
Overall Number of Units Analyzed
Type of Units Analyzed: Routine visit done every 8 weeks
206 191
Count of Units
Unit of Measure: Routine visit done every 8 weeks
65
  31.6%
51
  26.7%
Time Frame Following administration of first study drug to 6 weeks postpartum
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Hide Arm/Group Description

Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP placebo (tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Placebo

Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.

Infants will be given DP (half strength tablets once a day for 3 consecutive days) every four weeks from 2 months to 24 months of age. Infants will be given TS daily starting at 6 weeks of life using weight-based guidelines.

Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy

Monthly dihydroartemisinin-piperaquine (DP) for infants

All-Cause Mortality
TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      0/100 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/100 (4.00%)      6/100 (6.00%)    
Blood and lymphatic system disorders     
Anemia   3/100 (3.00%)  2/100 (2.00%) 
Congenital, familial and genetic disorders     
Congenital anomaly   1/100 (1.00%)  4/100 (4.00%) 
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 0%
TS + DP Placebo Pregnancy Daily TS + Monthly DP Pregnancy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/100 (92.00%)      91/100 (91.00%)    
Blood and lymphatic system disorders     
Anemia   40/100 (40.00%)  49 38/100 (38.00%)  45
Thrombocytopenia   11/100 (11.00%)  11 10/100 (10.00%)  11
General disorders     
Abdominal pain   68/100 (68.00%)  85 63/100 (63.00%)  74
Cough   41/100 (41.00%)  69 43/100 (43.00%)  55
Headache   34/100 (34.00%)  39 37/100 (37.00%)  43
Malaise   24/100 (24.00%)  27 21/100 (21.00%)  24
Diarrhea   14/100 (14.00%)  17 11/100 (11.00%)  14
Chills   9/100 (9.00%)  11 11/100 (11.00%)  11
Vomiting   6/100 (6.00%)  7 7/100 (7.00%)  7
Anorexia   6/100 (6.00%)  6 4/100 (4.00%)  4
Hepatobiliary disorders     
Elevated ALT level   0/100 (0.00%)  0 1/100 (1.00%)  1
Pregnancy, puerperium and perinatal conditions     
Stillbirth   0/100 (0.00%)  0 1/100 (1.00%)  1
Psychiatric disorders     
Altered mental status   0/100 (0.00%)  0 1/100 (1.00%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory Distress   1/100 (1.00%)  1 0/100 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Grant Dorsey
Organization: UCSF
Phone: 415-206-4680
Publications of Results:
Responsible Party: Diana Havlir, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02282293     History of Changes
Other Study ID Numbers: PROMOTE-BC2
First Submitted: October 30, 2014
First Posted: November 4, 2014
Results First Submitted: September 19, 2018
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019