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Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples (Partners PrEP)

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ClinicalTrials.gov Identifier: NCT00557245
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : November 27, 2014
Last Update Posted : November 27, 2014
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Connie Celum, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions HIV-1 Infections
HIV Infections
Interventions Drug: Tenofovir Disoproxil Fumarate (TDF)
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
Drug: Placebo
Enrollment 4758

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily. FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Period Title: Overall Study
Started 1589 1583 1586
Completed 1577 1571 1574
Not Completed 12 12 12
Reason Not Completed
Lost to Follow-up             7             8             10
Ineligible             5             4             2
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo Total
Hide Arm/Group Description TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily. FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily Placebo TDF & Placebo FTC/TDF, 1 tablet each daily. Total of all reporting groups
Overall Number of Baseline Participants 1584 1579 1584 4747
Hide Baseline Analysis Population Description
All randomized participants, less those who were found to be ineligible (n=11)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1584 participants 1579 participants 1584 participants 4747 participants
18-24 years 184 177 172 533
25-34 years 721 690 688 2099
35-44 years 480 498 513 1491
45 years and older 199 214 211 624
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1584 participants 1579 participants 1584 participants 4747 participants
Female
598
  37.8%
566
  35.8%
621
  39.2%
1785
  37.6%
Male
986
  62.2%
1013
  64.2%
963
  60.8%
2962
  62.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1584 participants 1579 participants 1584 participants 4747 participants
Kenya 700 698 697 2095
Uganda 884 881 887 2652
Percentage of participants who had unprotected sex in the past month   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 1584 participants 1579 participants 1584 participants 4747 participants
28 26 26 80
[1]
Measure Description: The percentage of participants who had any unprotected sex acts in the prior month.
1.Primary Outcome
Title Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
Hide Description The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, less those who were found to ineligible (n=11), less those found to be infected at enrollment (n=14), and less those who did not return for any follow-up (n=25).
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Overall Number of Participants Analyzed 1572 1568 1568
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 100 person years
0.65
(0.38 to 1.05)
0.50
(0.27 to 0.85)
1.99
(1.49 to 2.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold was 0.05.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.19 to 0.56
Estimation Comments Placebo arm is the reference group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold was 0.05.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.13 to 0.45
Estimation Comments Placebo arm is the reference group.
2.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants, less those found to be ineligible (n=11)
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Overall Number of Participants Analyzed 1584 1579 1584
Measure Type: Number
Unit of Measure: Participants
118 115 118
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
Hide Description Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Overall Number of Participants Analyzed 1571 1565 1570
Measure Type: Number
Unit of Measure: percentage of doses taken of dispensed
97 97 97
4.Secondary Outcome
Title Study Drug Adherence: Self-reported Missed Doses of Study Drug
Hide Description Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with self-reported adherence.
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF + Placebo FTC/TDF orally, once daily.
Overall Number of Participants Analyzed 1549 1552 1551
Measure Type: Number
Unit of Measure: percentage of visits
Missed any doses 15 15 15
Missed 2+ consecutive doses 4 4 4
5.Secondary Outcome
Title Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC
Hide Description

HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.

Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1).

Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who seroconverted during the Partners PrEP trial, including those who were retrospectively found to be HIV infected at enrollment (TDF arm: n=5; FTC-TDF arm: n=3; placebo arm: n=6). For 4 of 96 HIV-1 seroconverters (TDF arm: n=2; FTC-TDF arm: n=1; placebo arm: n=1) HIV-1 RNA was unable to be amplified for HIV-1 resistance testing.
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Overall Number of Participants Analyzed 20 15 57
Measure Type: Number
Unit of Measure: Participants
1 1 0
6.Secondary Outcome
Title Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
Hide Description

Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.

N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics).

Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized participants, less those found to be ineligible (n=11)
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Overall Number of Participants Analyzed 1584 1579 1584
Measure Type: Number
Unit of Measure: participants
102 76 85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Regression, Logistic
Comments Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Regression, Logistic
Comments Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.
7.Secondary Outcome
Title Prevalence of Unprotected Sex During Follow-up
Hide Description Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, less those found to be ineligible (n=11).
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF + Placebo FTC/TDF orally, once daily.
Overall Number of Participants Analyzed 1584 1579 1584
Measure Type: Number
Unit of Measure: percentage of visits
14 13 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Regression, Logistic
Comments Generalized estimating equations, logistic link, with robust standard errors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Regression, Logistic
Comments Generalized estimating equations, logistic link, with robust standard errors.
8.Secondary Outcome
Title Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
Hide Description Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized female participants, less those found to be ineligible (n=7)
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Overall Number of Participants Analyzed 595 565 621
Overall Number of Units Analyzed
Type of Units Analyzed: Live-born infants
81 47 66
Measure Type: Number
Unit of Measure: Number of live-born infants
4 4 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Regression, Logistic
Comments Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Regression, Logistic
Comments generalized estimating equations with logistic link to account for multiple pregnancies and multiple births
9.Secondary Outcome
Title Length Among Infants Born to Female Participants Taking Study Drug
Hide Description The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Time Frame up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Infants born to women taking study drug during follow-up
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF + Placebo FTC/TDF orally, once daily.
Overall Number of Participants Analyzed 81 47 66
Measure Type: Number
Unit of Measure: z-score difference per study month
-0.006 0.036 -0.033
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Mixed Models Analysis
Comments linear mixed-effects model
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Mixed Models Analysis
Comments Linear mixed-effects model
Method of Estimation Estimation Parameter Slope Difference over time
Estimated Value 0.07
Estimation Comments Placebo arm is the reference group.
10.Secondary Outcome
Title Weight Among Infants Born to Female Participants Taking Study Drug
Hide Description The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Time Frame up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Infants born to women taking study drug during follow-up
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF + Placebo FTC/TDF orally, once daily.
Overall Number of Participants Analyzed 81 47 66
Measure Type: Number
Unit of Measure: z-score difference per study month
-0.021 0.009 -0.056
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments Linear mixed effects model
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Linear mixed effects model
11.Secondary Outcome
Title Head Circumference Among Infants Born to Female Participants Taking Study Drug
Hide Description The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.
Time Frame up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Infants born to women taking study drug during follow-up
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description:
Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo TDF + Placebo FTC/TDF orally, once daily.
Overall Number of Participants Analyzed 81 47 66
Measure Type: Number
Unit of Measure: z-score difference per study month
-0.057 -0.005 -0.079
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tenofovir Disoproxil Fumarate (TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Mixed Models Analysis
Comments Linear mixed effects model
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments Linear mixed effects model
Time Frame Up to 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Hide Arm/Group Description TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily. FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
All-Cause Mortality
Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   118/1584 (7.45%)      115/1579 (7.28%)      118/1584 (7.45%)    
Congenital, familial and genetic disorders       
ANKYLOGLOSSIA CONGENITAL   2/1584 (0.13%)  2 0/1579 (0.00%)  0 0/1584 (0.00%)  0
EXOMPHALOS   0/1584 (0.00%)  0 1/1579 (0.06%)  1 1/1584 (0.06%)  1
HYPOSPADIAS   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
POLYDACTYLY   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
SYNDACTYLY   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
VENTRICULAR SEPTAL DEFECT   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
Eye disorders       
BLINDNESS   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
CATARACT   1/1584 (0.06%)  1 1/1579 (0.06%)  1 0/1584 (0.00%)  0
OPTIC NEUROPATHY   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
Gastrointestinal disorders       
ABDOMINAL HERNIA   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
ABDOMINAL PAIN   1/1584 (0.06%)  1 2/1579 (0.13%)  2 2/1584 (0.13%)  2
ACUTE ABDOMEN   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
DIARRHOEA   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
DIARRHOEA HAEMORRHAGIC   1/1584 (0.06%)  1 1/1579 (0.06%)  1 0/1584 (0.00%)  0
DIVERTICULUM INTESTINAL   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
FOOD POISONING   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
GASTRITIS   3/1584 (0.19%)  3 0/1579 (0.00%)  0 0/1584 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
HAEMATEMESIS   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
INGUINAL HERNIA   1/1584 (0.06%)  1 3/1579 (0.19%)  3 3/1584 (0.19%)  3
PEPTIC ULCER   4/1584 (0.25%)  4 1/1579 (0.06%)  1 3/1584 (0.19%)  4
PROCTITIS   0/1584 (0.00%)  0 1/1579 (0.06%)  1 1/1584 (0.06%)  1
TOOTH DEVELOPMENT DISORDER   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
UMBILICAL HERNIA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
VOLVULUS   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
General disorders       
ASTHENIA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
INFLUENZA LIKE ILLNESS   0/1584 (0.00%)  0 2/1579 (0.13%)  2 0/1584 (0.00%)  0
Immune system disorders       
ALLERGY TO ARTHROPOD STING   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
ANAPHYLACTIC REACTION   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
Infections and infestations       
ACUTE HIV INFECTION   1/1584 (0.06%)  1 0/1579 (0.00%)  0 1/1584 (0.06%)  1
ANAL INFECTION   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  3
APPENDICITIS   2/1584 (0.13%)  2 0/1579 (0.00%)  0 0/1584 (0.00%)  0
BREAST ABSCESS   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
BRONCHOPNEUMONIA   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
BRUCELLOSIS   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
CEREBRAL MALARIA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
CERVICITIS   1/598 (0.17%)  1 0/566 (0.00%)  0 0/621 (0.00%)  0
DYSENTERY   2/1584 (0.13%)  2 0/1579 (0.00%)  0 0/1584 (0.00%)  0
FEBRILE INFECTION   1/1584 (0.06%)  1 2/1579 (0.13%)  2 1/1584 (0.06%)  1
GASTROENTERITIS   2/1584 (0.13%)  2 1/1579 (0.06%)  1 1/1584 (0.06%)  1
GASTROENTERITIS SHIGELLA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
HORDEOLUM   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
LOBAR PNEUMONIA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
LUNG ABSCESS   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
MALARIA   28/1584 (1.77%)  31 28/1579 (1.77%)  30 37/1584 (2.34%)  40
ORCHITIS   1/1584 (0.06%)  1 1/1579 (0.06%)  1 0/1584 (0.00%)  0
PELVIC ABSCESS   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
PELVIC INFLAMMATORY DISEASE   3/598 (0.50%)  3 0/566 (0.00%)  0 0/621 (0.00%)  0
PNEUMONIA   0/1584 (0.00%)  0 1/1579 (0.06%)  1 2/1584 (0.13%)  2
POSTOPERATIVE WOUND INFECTION   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
PULMONARY TUBERCULOSIS   0/1584 (0.00%)  0 1/1579 (0.06%)  1 1/1584 (0.06%)  1
RESPIRATORY TRACT INFECTION   0/1584 (0.00%)  0 1/1579 (0.06%)  1 1/1584 (0.06%)  1
SALPINGITIS   0/598 (0.00%)  0 0/566 (0.00%)  0 1/621 (0.16%)  1
SEPSIS   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
TYPHOID FEVER   1/1584 (0.06%)  1 2/1579 (0.13%)  2 1/1584 (0.06%)  1
URINARY TRACT INFECTION   4/1584 (0.25%)  4 0/1579 (0.00%)  0 1/1584 (0.06%)  1
WOUND INFECTION   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
Injury, poisoning and procedural complications       
ALCOHOL POISONING   2/1584 (0.13%)  2 0/1579 (0.00%)  0 0/1584 (0.00%)  0
CATARACT TRAUMATIC   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
CHEMICAL EYE INJURY   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
CHEST INJURY   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
CLAVICLE FRACTURE   0/1584 (0.00%)  0 1/1579 (0.06%)  2 0/1584 (0.00%)  0
DRUG TOXICITY   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
ELECTROCUTION   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
FALL   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
FEMUR FRACTURE   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
FIBULA FRACTURE   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
GUN SHOT WOUND   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
HEAD INJURY   0/1584 (0.00%)  0 3/1579 (0.19%)  3 3/1584 (0.19%)  3
HUMERUS FRACTURE   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
INDUCED ABORTION HAEMORRHAGE   0/598 (0.00%)  0 0/566 (0.00%)  0 1/621 (0.16%)  1
INJURY   1/1584 (0.06%)  1 0/1579 (0.00%)  0 1/1584 (0.06%)  1
LOWER LIMB FRACTURE   0/1584 (0.00%)  0 0/1579 (0.00%)  0 2/1584 (0.13%)  2
POISONING   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
ROAD TRAFFIC ACCIDENT   1/1584 (0.06%)  1 5/1579 (0.32%)  5 6/1584 (0.38%)  6
SCIATIC NERVE INJURY   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
SOFT TISSUE INJURY   3/1584 (0.19%)  3 2/1579 (0.13%)  2 3/1584 (0.19%)  3
STRUCK BY LIGHTNING   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
TENDON RUPTURE   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
THERMAL BURN   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
TIBIA FRACTURE   1/1584 (0.06%)  1 0/1579 (0.00%)  0 1/1584 (0.06%)  1
Investigations       
ALANINE AMINOTRANSFERASE INCREASED   3/1584 (0.19%)  3 2/1579 (0.13%)  2 2/1584 (0.13%)  2
ASPARTATE AMINOTRANSFERASE INCREASED   4/1584 (0.25%)  4 2/1579 (0.13%)  2 2/1584 (0.13%)  2
BLOOD BILIRUBIN INCREASED   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
BLOOD GLUCOSE DECREASED   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
BLOOD PHOSPHORUS DECREASED   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
HAEMOGLOBIN DECREASED   1/1584 (0.06%)  1 5/1579 (0.32%)  5 2/1584 (0.13%)  2
NEUTROPHIL COUNT DECREASED   13/1584 (0.82%)  15 18/1579 (1.14%)  20 10/1584 (0.63%)  10
PLATELET COUNT DECREASED   1/1584 (0.06%)  1 5/1579 (0.32%)  5 4/1584 (0.25%)  5
WEIGHT DECREASED   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
WHITE BLOOD CELL COUNT DECREASED   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
Metabolism and nutrition disorders       
DEHYDRATION   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
DIABETES MELLITUS   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
DIABETIC COMPLICATION   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
HYPERGLYCAEMIA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
Musculoskeletal and connective tissue disorders       
BACK PAIN   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
FRACTURE MALUNION   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
INTERVERTEBRAL DISC PROTRUSION   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
MYALGIA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
CERVIX CARCINOMA   0/598 (0.00%)  0 0/566 (0.00%)  0 1/621 (0.16%)  1
OESOPHAGEAL CARCINOMA   1/1584 (0.06%)  1 0/1579 (0.00%)  0 1/1584 (0.06%)  1
UTERINE LEIOMYOMA   0/598 (0.00%)  0 1/566 (0.18%)  1 0/621 (0.00%)  0
Nervous system disorders       
CEREBRAL INFARCTION   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
CEREBROVASCULAR ACCIDENT   1/1584 (0.06%)  1 0/1579 (0.00%)  0 1/1584 (0.06%)  1
CONVULSION   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
HEADACHE   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
LOSS OF CONSCIOUSNESS   2/1584 (0.13%)  2 0/1579 (0.00%)  0 0/1584 (0.00%)  0
NEUROPATHY PERIPHERAL   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
SYNCOPE   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
Pregnancy, puerperium and perinatal conditions       
ABORTION SPONTANEOUS   7/598 (1.17%)  7 8/566 (1.41%)  8 6/621 (0.97%)  6
ANTEPARTUM HAEMORRHAGE   0/598 (0.00%)  0 1/566 (0.18%)  1 0/621 (0.00%)  0
NORMAL DELIVERY   5/598 (0.84%)  5 2/566 (0.35%)  2 2/621 (0.32%)  2
PERINEAL LACERATION   1/598 (0.17%)  1 0/566 (0.00%)  0 0/621 (0.00%)  0
POSTPARTUM HAEMORRHAGE   0/598 (0.00%)  0 0/566 (0.00%)  0 1/621 (0.16%)  1
PREMATURE LABOUR   1/598 (0.17%)  1 0/566 (0.00%)  0 1/621 (0.16%)  1
PROLONGED LABOUR   0/598 (0.00%)  0 1/566 (0.18%)  1 0/621 (0.00%)  0
Psychiatric disorders       
ACUTE PSYCHOSIS   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
ANXIETY   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
COMPLETED SUICIDE   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
DEPRESSION   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
MAJOR DEPRESSION   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
SCHIZOPHRENIA   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
SUICIDE ATTEMPT   1/1584 (0.06%)  1 2/1579 (0.13%)  2 1/1584 (0.06%)  1
Renal and urinary disorders       
ACUTE PRERENAL FAILURE   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
Reproductive system and breast disorders       
BENIGN PROSTATIC HYPERPLASIA   1/986 (0.10%)  1 1/1013 (0.10%)  1 0/963 (0.00%)  0
CERVIX DISORDER   1/598 (0.17%)  1 0/566 (0.00%)  0 0/621 (0.00%)  0
FALLOPIAN TUBE CYST   0/598 (0.00%)  0 0/566 (0.00%)  0 1/621 (0.16%)  1
METRORRHAGIA   1/598 (0.17%)  1 0/566 (0.00%)  0 0/621 (0.00%)  0
OVARIAN CYST   0/598 (0.00%)  0 1/566 (0.18%)  1 1/621 (0.16%)  1
Respiratory, thoracic and mediastinal disorders       
ASTHMA   0/1584 (0.00%)  0 1/1579 (0.06%)  1 1/1584 (0.06%)  1
PLEURISY   0/1584 (0.00%)  0 0/1579 (0.00%)  0 1/1584 (0.06%)  1
PULMONARY EMBOLISM   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
Skin and subcutaneous tissue disorders       
SCAR PAIN   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
Social circumstances       
VICTIM OF CRIME   1/1584 (0.06%)  1 0/1579 (0.00%)  0 1/1584 (0.06%)  1
Surgical and medical procedures       
COLOSTOMY   1/1584 (0.06%)  1 0/1579 (0.00%)  0 0/1584 (0.00%)  0
Vascular disorders       
HYPERTENSION   0/1584 (0.00%)  0 1/1579 (0.06%)  1 0/1584 (0.00%)  0
HYPOTENSION   1/1584 (0.06%)  1 0/1579 (0.00%)  0 1/1584 (0.06%)  1
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 1%
Tenofovir Disoproxil Fumarate (TDF) Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1306/1584 (82.45%)      1316/1579 (83.34%)      1297/1584 (81.88%)    
Gastrointestinal disorders       
DIARRHOEA   48/1584 (3.03%)  56 37/1579 (2.34%)  39 39/1584 (2.46%)  41
GASTRITIS   20/1584 (1.26%)  22 28/1579 (1.77%)  31 24/1584 (1.52%)  28
ABDOMINAL PAIN   23/1584 (1.45%)  23 22/1579 (1.39%)  23 24/1584 (1.52%)  24
DIARRHOEA HAEMORRHAGIC   17/1584 (1.07%)  17 16/1579 (1.01%)  16 15/1584 (0.95%)  17
Infections and infestations       
MALARIA   290/1584 (18.31%)  371 267/1579 (16.91%)  356 280/1584 (17.68%)  352
UPPER RESPIRATORY TRACT INFECTION   125/1584 (7.89%)  147 159/1579 (10.07%)  189 142/1584 (8.96%)  169
RESPIRATORY TRACT INFECTION   108/1584 (6.82%)  117 91/1579 (5.76%)  107 114/1584 (7.20%)  133
URINARY TRACT INFECTION   105/1584 (6.63%)  121 86/1579 (5.45%)  96 103/1584 (6.50%)  122
PELVIC INFLAMMATORY DISEASE   59/598 (9.87%)  71 48/566 (8.48%)  55 55/621 (8.86%)  62
GASTROENTERITIS   33/1584 (2.08%)  36 32/1579 (2.03%)  34 30/1584 (1.89%)  32
TYPHOID FEVER   32/1584 (2.02%)  39 28/1579 (1.77%)  31 23/1584 (1.45%)  24
SYPHILIS   28/1584 (1.77%)  30 27/1579 (1.71%)  31 23/1584 (1.45%)  24
CELLULITIS   26/1584 (1.64%)  27 12/1579 (0.76%)  13 26/1584 (1.64%)  27
URETHRITIS   26/1584 (1.64%)  33 16/1579 (1.01%)  16 20/1584 (1.26%)  22
PNEUMONIA   16/1584 (1.01%)  17 17/1579 (1.08%)  19 21/1584 (1.33%)  23
PHARYNGITIS   16/1584 (1.01%)  16 18/1579 (1.14%)  18 15/1584 (0.95%)  15
Injury, poisoning and procedural complications       
SOFT TISSUE INJURY   18/1584 (1.14%)  18 19/1579 (1.20%)  19 16/1584 (1.01%)  17
Investigations       
NEUTROPHIL COUNT DECREASED   598/1584 (37.75%)  1109 686/1579 (43.45%)  1322 577/1584 (36.43%)  1076
BLOOD PHOSPHORUS DECREASED   440/1584 (27.78%)  763 460/1579 (29.13%)  785 473/1584 (29.86%)  787
HAEMOGLOBIN DECREASED   259/1584 (16.35%)  384 230/1579 (14.57%)  335 231/1584 (14.58%)  331
PLATELET COUNT DECREASED   190/1584 (11.99%)  306 188/1579 (11.91%)  305 177/1584 (11.17%)  298
BLOOD BICARBONATE DECREASED   123/1584 (7.77%)  142 118/1579 (7.47%)  130 135/1584 (8.52%)  148
ASPARTATE AMINOTRANSFERASE INCREASED   93/1584 (5.87%)  138 103/1579 (6.52%)  146 96/1584 (6.06%)  124
BLOOD CREATININE INCREASED   76/1584 (4.80%)  99 107/1579 (6.78%)  126 86/1584 (5.43%)  108
ALANINE AMINOTRANSFERASE INCREASED   90/1584 (5.68%)  103 87/1579 (5.51%)  104 73/1584 (4.61%)  85
WHITE BLOOD CELL COUNT DECREASED   50/1584 (3.16%)  59 71/1579 (4.50%)  93 64/1584 (4.04%)  83
BLOOD BILIRUBIN INCREASED   56/1584 (3.54%)  82 49/1579 (3.10%)  64 63/1584 (3.98%)  88
Pregnancy, puerperium and perinatal conditions       
ABORTION SPONTANEOUS   13/598 (2.17%)  14 19/566 (3.36%)  20 17/621 (2.74%)  17
Renal and urinary disorders       
PROTEINURIA   40/1584 (2.53%)  47 36/1579 (2.28%)  46 34/1584 (2.15%)  43
URETHRAL DISCHARGE   17/1584 (1.07%)  20 21/1579 (1.33%)  23 18/1584 (1.14%)  22
Reproductive system and breast disorders       
GENITAL ULCERATION   26/1584 (1.64%)  29 35/1579 (2.22%)  48 34/1584 (2.15%)  38
Respiratory, thoracic and mediastinal disorders       
PHARYNGOLARYNGEAL PAIN   14/1584 (0.88%)  14 19/1579 (1.20%)  19 27/1584 (1.70%)  28
COUGH   22/1584 (1.39%)  25 20/1579 (1.27%)  21 11/1584 (0.69%)  12
Vascular disorders       
HYPERTENSION   19/1584 (1.20%)  20 14/1579 (0.89%)  18 30/1584 (1.89%)  42
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Connie Celum
Organization: University of Washington
Phone: 206-520-3824
EMail: ccelum@uw.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Connie Celum, University of Washington
ClinicalTrials.gov Identifier: NCT00557245     History of Changes
Other Study ID Numbers: 32528-A
IND 75,365;
07-7454-A-01
First Submitted: November 8, 2007
First Posted: November 12, 2007
Results First Submitted: October 30, 2014
Results First Posted: November 27, 2014
Last Update Posted: November 27, 2014