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FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

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ClinicalTrials.gov Identifier: NCT00625404
Recruitment Status : Completed
First Posted : February 28, 2008
Results First Posted : April 16, 2014
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
FHI 360

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Drug: Truvada
Other: Placebo
Enrollment 2120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg). Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Period Title: Overall Study
Started 1062 1058
Completed 855 885
Not Completed 207 173
Arm/Group Title Truvada Arm Placebo Arm Total
Hide Arm/Group Description Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients. Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients. Total of all reporting groups
Overall Number of Baseline Participants 1062 1058 2120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1062 participants 1058 participants 2120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1062
 100.0%
1058
 100.0%
2120
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1062 participants 1058 participants 2120 participants
23
(18 to 35)
23
(18 to 35)
23
(18 to 35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1062 participants 1058 participants 2120 participants
Female
1062
 100.0%
1058
 100.0%
2120
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title HIV Infection
Hide Description HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.
Time Frame Cumulative HIV infection between enrollment and 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Overall Number of Participants Analyzed 1024 1032
Measure Type: Number
Unit of Measure: participants
33 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is > 0.3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.59 to 1.52
Estimation Comments [Not Specified]
2.Primary Outcome
Title Confirmed Grade 2 or Higher Serum Creatinine Toxicity
Hide Description Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal
Time Frame cumulative toxicity through 52 weeks of product use and 4 weeks post product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 1021 1033
Measure Type: Number
Unit of Measure: participants
4 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Primary Outcome
Title Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
Hide Description The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.
Time Frame 10-26 months per site
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.
The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.
Overall Number of Participants Analyzed 1025 1033
Measure Type: Number
Unit of Measure: Number of adverse events
2257 2384
4.Primary Outcome
Title Confirmed Grade 3 or Higher Reduction in Phosphorus
Hide Description Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL
Time Frame Through 52 weeks on product and 4 weeks post-product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 1021 1033
Measure Type: Number
Unit of Measure: participants
45 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments Log-rank test for difference in rates between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Primary Outcome
Title Confirmed Grade 3 or Higher ALT Elevation
Hide Description Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal
Time Frame Through 52 weeks on product and 4 weeks post-product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 1021 1033
Measure Type: Number
Unit of Measure: participants
6 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments Log-rank test for difference in rates between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Primary Outcome
Title Confirmed Grade 3 or Higher AST Elevation
Hide Description Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal
Time Frame Through 52 weeks on product and 4 weeks post-product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 1021 1033
Measure Type: Number
Unit of Measure: participants
3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments Log-rank test for difference in rates between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Plasma HIV RNA Level (HIV-1 Viral Load)
Hide Description Viral load at the time of HIV detection, HIV conversion and through 16 weeks
Time Frame up to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 27 21
Log Mean (Standard Deviation)
Unit of Measure: log copies/mL
4.40  (1.05) 4.37  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments t-test for difference on viral loads
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Estimation Comments [Not Specified]
8.Secondary Outcome
Title CD4+ T-cell Count
Hide Description CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks
Time Frame Up to 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 26 20
Mean (Standard Deviation)
Unit of Measure: cells/mL
579.3  (318.2) 601.4  (318.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments t-test for difference in mean CD-4 counts
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title FTC and/or Tenofovir Resistance
Hide Description

Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).

participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time.

Time Frame up to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All women who seroconverted were assessed for possible resistance.
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 33 35
Measure Type: Number
Unit of Measure: participants
3 1
10.Secondary Outcome
Title Pregnancy Complications
Hide Description Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications
Time Frame up to 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 70 45
Measure Type: Number
Unit of Measure: participants
20 10
11.Secondary Outcome
Title Pill Counts and Participant Report of Adherence to Once-daily Pill Taking
Hide Description Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts
Time Frame Up to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 1024 1032
Mean (Standard Deviation)
Unit of Measure: percentage of days
87  (0.20) 89  (0.17)
12.Secondary Outcome
Title Participant Report of Change in Number of Sexual Partners
Hide Description Difference in mean number of reported sexual partners between final study visit and enrollment visit
Time Frame Up to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Women reporting on sexual behavior during follow-up
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description:
Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Number of Participants Analyzed 977 989
Mean (Standard Deviation)
Unit of Measure: mean number of sexual partners
-0.14  (0.60) -0.13  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Truvada Arm, Placebo Arm
Comments t-test for difference in change in number of sexual partners over time
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .01
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
 
Arm/Group Title Truvada Arm Placebo Arm
Hide Arm/Group Description Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg). Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
All-Cause Mortality
Truvada Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Truvada Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/1025 (3.22%)      23/1033 (2.23%)    
Blood and lymphatic system disorders     
anemia  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Congenital, familial and genetic disorders     
exomphalos  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Gastrointestinal disorders     
typhoid fever  1  2/1025 (0.20%)  2 1/1033 (0.10%)  1
gastroenteritis  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Infections and infestations     
malaria  1  4/1025 (0.39%)  4 3/1033 (0.29%)  3
pneumonia  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
respiratory tract infection  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
tuberculosis  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Bartholin's abscess  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
influenza  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
pelvic inflammatory disease  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
urinary tract infection  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Injury, poisoning and procedural complications     
fracture  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
wound  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
abdominal injury  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
joint sprain  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Musculoskeletal and connective tissue disorders     
joint contracture  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
joint dislocation  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Nervous system disorders     
syncope  1  2/1025 (0.20%)  2 1/1033 (0.10%)  1
muscular weakness  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
neuropathy peripheral  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
abortion  1  3/1025 (0.29%)  3 0/1033 (0.00%)  0
ectopic pregnancy  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
foetal distress syndrome  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
premature rupture of the membranes  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Psychiatric disorders     
intentional overdose  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
depression  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
withdrawal syndrome  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Reproductive system and breast disorders     
menorrhagia  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Respiratory, thoracic and mediastinal disorders     
asthma  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
Surgical and medical procedures     
removal of foreign body  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Vascular disorders     
hypotension  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Truvada Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   761/1025 (74.24%)      749/1033 (72.51%)    
Blood and lymphatic system disorders     
Anaemia  1  6/1025 (0.59%)  6 5/1033 (0.48%)  6
Lymphadenopathy  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Cardiac disorders     
Palpitations  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
Congenital, familial and genetic disorders     
Exomphalos  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Ear and labyrinth disorders     
Ear pain  1  1/1025 (0.10%)  1 5/1033 (0.48%)  5
Otorrhoea  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Eye disorders     
Eye pain  1  1/1025 (0.10%)  1 4/1033 (0.39%)  4
Abnormal vision  1  1/1025 (0.10%)  2 1/1033 (0.10%)  1
Dry eye  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Eye pruritus  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Photophobia  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Vision blurred  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Visual acuity reduced  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  50/1025 (4.88%)  52 32/1033 (3.10%)  33
Abdominal pain  1  27/1025 (2.63%)  27 27/1033 (2.61%)  27
Vomiting  1  37/1025 (3.61%)  38 12/1033 (1.16%)  12
Typhoid fever  1  24/1025 (2.34%)  25 14/1033 (1.36%)  17
Gastroenteritis  1  21/1025 (2.05%)  21 14/1033 (1.36%)  16
Diarrhoea  1  17/1025 (1.66%)  18 17/1033 (1.65%)  21
Dyspepsia  1  11/1025 (1.07%)  11 16/1033 (1.55%)  17
Toothache  1  13/1025 (1.27%)  15 7/1033 (0.68%)  7
Gastritis  1  8/1025 (0.78%)  8 11/1033 (1.06%)  11
Dysentery  1  7/1025 (0.68%)  8 5/1033 (0.48%)  5
Flatulence  1  5/1025 (0.49%)  5 6/1033 (0.58%)  6
Dental caries  1  2/1025 (0.20%)  2 3/1033 (0.29%)  3
Peptic ulcer  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
Abdominal distension  1  0/1025 (0.00%)  0 2/1033 (0.19%)  2
Aphthous stomatitis  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Colitis  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Constipation  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Haemorrhoids  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Cheilitis  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Gingival pain  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Gingivitis  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Hyperphagia  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Mouth ulceration  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Odynophagia  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Rectal haemorrhage  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Rectal prolapse  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Stomatitis  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Umbilical hernia  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
General disorders     
Fatigue  1  17/1025 (1.66%)  17 8/1033 (0.77%)  8
Malaise  1  7/1025 (0.68%)  8 11/1033 (1.06%)  11
Pain  1  4/1025 (0.39%)  4 2/1033 (0.19%)  2
Oedema peripheral  1  1/1025 (0.10%)  1 3/1033 (0.29%)  3
Pyrexia  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Chills  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Local swelling  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Procedural pain  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Thirst  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Immune system disorders     
Dermatitis allergic  1  30/1025 (2.93%)  33 21/1033 (2.03%)  21
Pruritus allergic  1  11/1025 (1.07%)  12 6/1033 (0.58%)  6
Conjunctivitis allergic  1  3/1025 (0.29%)  3 9/1033 (0.87%)  9
Hypersensitivity  1  8/1025 (0.78%)  8 2/1033 (0.19%)  2
Rhinitis allergic  1  1/1025 (0.10%)  1 4/1033 (0.39%)  5
Allergic cough  1  2/1025 (0.20%)  3 1/1033 (0.10%)  1
Allergic sinusitis  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Idiopathic urticaria  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Infections and infestations     
Malaria  1  123/1025 (12.00%)  154 121/1033 (11.71%)  157
Respiratory tract infection  1  96/1025 (9.37%)  108 108/1033 (10.45%)  125
Vaginitis bacterial  1  67/1025 (6.54%)  69 81/1033 (7.84%)  81
Candidiasis  1  60/1025 (5.85%)  62 52/1033 (5.03%)  57
Chlamydial infection  1  35/1025 (3.41%)  35 38/1033 (3.68%)  39
Urinary tract infection  1  23/1025 (2.24%)  23 34/1033 (3.29%)  38
Nasopharyngitis  1  19/1025 (1.85%)  21 36/1033 (3.48%)  42
Tonsillitis  1  23/1025 (2.24%)  28 23/1033 (2.23%)  26
Tinea infection  1  18/1025 (1.76%)  18 19/1033 (1.84%)  22
Pelvic inflammatory disease  1  16/1025 (1.56%)  16 20/1033 (1.94%)  20
Vaginal infection  1  20/1025 (1.95%)  23 12/1033 (1.16%)  12
Trichomoniasis  1  13/1025 (1.27%)  13 16/1033 (1.55%)  16
Influenza  1  13/1025 (1.27%)  14 14/1033 (1.36%)  16
Pneumonia  1  12/1025 (1.17%)  13 13/1033 (1.26%)  14
Cervicitis  1  11/1025 (1.07%)  11 10/1033 (0.97%)  10
Abscess  1  9/1025 (0.88%)  9 8/1033 (0.77%)  8
Gonorrhoea  1  10/1025 (0.98%)  10 5/1033 (0.48%)  5
Sinusitis  1  7/1025 (0.68%)  7 2/1033 (0.19%)  2
Furuncle  1  5/1025 (0.49%)  5 3/1033 (0.29%)  4
Tuberculosis  1  4/1025 (0.39%)  4 2/1033 (0.19%)  2
Vulvovaginitis  1  4/1025 (0.39%)  4 2/1033 (0.19%)  2
Wound infection  1  3/1025 (0.29%)  3 3/1033 (0.29%)  3
Eye infection  1  3/1025 (0.29%)  3 2/1033 (0.19%)  2
Oral herpes  1  4/1025 (0.39%)  5 1/1033 (0.10%)  1
Pharyngitis  1  3/1025 (0.29%)  3 1/1033 (0.10%)  1
Herpes zoster  1  2/1025 (0.20%)  2 1/1033 (0.10%)  1
Otitis externa  1  2/1025 (0.20%)  2 1/1033 (0.10%)  1
Pyelonephritis  1  0/1025 (0.00%)  0 3/1033 (0.29%)  3
Helminthic infection  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Hordeolum  1  0/1025 (0.00%)  0 2/1033 (0.19%)  2
Otitis media  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Amoebiasis  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Bartholin's abscess  1  1/1025 (0.10%)  2 0/1033 (0.00%)  0
Bronchopneumonia  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Cellulitis  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Ear infection  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Extrapulmonary tuberculosis  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Herpes simplex  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Parotitis  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Rhinitis  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Injury, poisoning and procedural complications     
Wound  1  5/1025 (0.49%)  5 11/1033 (1.06%)  11
Joint sprain  1  5/1025 (0.49%)  5 2/1033 (0.19%)  2
Animal bite  1  1/1025 (0.10%)  1 3/1033 (0.29%)  3
Fracture  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
Human bite  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Incision site pain  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Periorbital haematoma  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Thermal burn  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Abdominal injury  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Anthropod sting  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Contusion  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Contusion of knee  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Face injury  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Injury  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Mouth injury  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Tooth fracture  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Investigations     
Blood phosphorus decreased  1  199/1025 (19.41%)  267 189/1033 (18.30%)  257
Aspartate aminotransferase increased  1  134/1025 (13.07%)  177 119/1033 (11.52%)  147
Alanine aminotransferase increased  1  119/1025 (11.61%)  162 110/1033 (10.65%)  125
Blood phosphorus increased  1  93/1025 (9.07%)  103 102/1033 (9.87%)  121
Blood creatinine increased  1  70/1025 (6.83%)  95 67/1033 (6.49%)  79
Liver function test abnormal  1  26/1025 (2.54%)  35 18/1033 (1.74%)  19
Blood bicarbonate decreased  1  12/1025 (1.17%)  13 20/1033 (1.94%)  22
Eosinophil count increased  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Platelet count increased  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Creatinine renal clearance decreased  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Glucose urine  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Haemoglobin decreased  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Heart rate decreased  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Hormonal level abnormal  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Renal function test abnormal  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Weight decreased  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  10/1025 (0.98%)  10 4/1033 (0.39%)  4
Anorexia  1  0/1025 (0.00%)  0 2/1033 (0.19%)  2
Dehydration  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  21/1025 (2.05%)  22 25/1033 (2.42%)  26
Arthralgia  1  14/1025 (1.37%)  15 6/1033 (0.58%)  6
Myalgia  1  6/1025 (0.59%)  6 10/1033 (0.97%)  12
Soft tissue injury  1  8/1025 (0.78%)  9 5/1033 (0.48%)  5
Musculoskeletal chest pain  1  4/1025 (0.39%)  4 5/1033 (0.48%)  5
Arthritis  1  3/1025 (0.29%)  3 4/1033 (0.39%)  4
Neck pain  1  2/1025 (0.20%)  2 3/1033 (0.29%)  3
Musculoskeletal stiffness  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Joint contracture  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Joint dislocation  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Muscle mass  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Osteitis  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Pain in extremity  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Synovial cyst  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Nervous system disorders     
Headache  1  134/1025 (13.07%)  153 148/1033 (14.33%)  173
Dizziness  1  52/1025 (5.07%)  56 45/1033 (4.36%)  46
Hypoaesthesia  1  5/1025 (0.49%)  6 3/1033 (0.29%)  3
Neuropathy peripheral  1  4/1025 (0.39%)  5 0/1033 (0.00%)  0
Syncope  1  2/1025 (0.20%)  2 2/1033 (0.19%)  2
Paraesthesia  1  3/1025 (0.29%)  3 0/1033 (0.00%)  0
Insomnia  1  0/1025 (0.00%)  0 2/1033 (0.19%)  3
Somnolence  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Burning sensation  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Hemiparesis  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Muscular weakness  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Neuritis  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Vision blurred  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion  1  11/1025 (1.07%)  11 7/1033 (0.68%)  7
Ectopic pregnancy  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Foetal distress syndrome  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Vomiting in pregnancy  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Abortion threatened  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Premature rupture of the membranes  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Somatoform disorder pregnancy  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Psychiatric disorders     
Intentional overdose  1  2/1025 (0.20%)  2 2/1033 (0.19%)  2
Anxiety  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Depression  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Mood swings  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Panic attack  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Withdrawal syndrome  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Renal and urinary disorders     
Dysuria  1  3/1025 (0.29%)  3 1/1033 (0.10%)  1
Proteinuria  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Haematuria  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Urinary incontinence  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Reproductive system and breast disorders     
Vaginal discharge  1  19/1025 (1.85%)  22 13/1033 (1.26%)  14
Dysfunctional uterine bleeding  1  17/1025 (1.66%)  18 13/1033 (1.26%)  13
Metrorrhagia  1  10/1025 (0.98%)  10 14/1033 (1.36%)  15
Menorrhagia  1  12/1025 (1.17%)  12 9/1033 (0.87%)  9
Dysmenorrhoea  1  8/1025 (0.78%)  8 6/1033 (0.58%)  6
Genital ulceration  1  10/1025 (0.98%)  10 1/1033 (0.10%)  2
Pelvic pain  1  3/1025 (0.29%)  3 4/1033 (0.39%)  4
Vulvovaginal pruritus  1  1/1025 (0.10%)  1 5/1033 (0.48%)  5
Amenorrhoea  1  0/1025 (0.00%)  0 2/1033 (0.19%)  2
Premenstrual syndrome  1  1/1025 (0.10%)  1 1/1033 (0.10%)  1
Breast discomfort  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Breast pain  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Coital bleeding  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Dyspareunia  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Galacthorrhoea  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Genital erosion  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Menometrorrhagia  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Ovarian cyst  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Uterine leiomyoma  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Vaginal ulceration  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  13/1025 (1.27%)  13 5/1033 (0.48%)  5
Cough  1  6/1025 (0.59%)  6 5/1033 (0.48%)  5
Asthma  1  3/1025 (0.29%)  3 4/1033 (0.39%)  6
Epistaxis  1  2/1025 (0.20%)  2 4/1033 (0.39%)  4
Chest pain  1  0/1025 (0.00%)  0 4/1033 (0.39%)  4
Bronchitis  1  1/1025 (0.10%)  1 2/1033 (0.19%)  3
Nasal congestion  1  1/1025 (0.10%)  1 2/1033 (0.19%)  2
Hyperventilation  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Pleurisy  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Postnasal drip  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Pulmonary congestion  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  6/1025 (0.59%)  6 10/1033 (0.97%)  10
Pruritus generalised  1  4/1025 (0.39%)  4 5/1033 (0.48%)  5
Pruritus  1  3/1025 (0.29%)  3 2/1033 (0.19%)  2
Dermatitis atopic  1  1/1025 (0.10%)  1 1/1033 (0.10%)  2
Eczema  1  0/1025 (0.00%)  0 2/1033 (0.19%)  2
Acne  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Angioedema  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Chloasma  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Dermatitis  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Dry skin  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Scar pain  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Skin exfoliation  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Skin hyperpigmentation  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Skin hypopigmentation  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Skin ulcer  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Urticaria  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Social circumstances     
Physical assault  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Surgical and medical procedures     
Removal of foreign body  1  0/1025 (0.00%)  0 1/1033 (0.10%)  1
Vascular disorders     
Hypertension  1  2/1025 (0.20%)  2 2/1033 (0.19%)  2
Venous insufficiency  1  3/1025 (0.29%)  3 0/1033 (0.00%)  0
Hypotension  1  2/1025 (0.20%)  2 0/1033 (0.00%)  0
Varicose vein  1  0/1025 (0.00%)  0 2/1033 (0.19%)  2
Lymphoedema  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Orthostatic hypotension  1  1/1025 (0.10%)  1 0/1033 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jennifer Deese, Principal Investigator
Organization: FHI 360
Phone: 919-544-7040 ext 11292
Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT00625404     History of Changes
Other Study ID Numbers: 10015
First Submitted: February 19, 2008
First Posted: February 28, 2008
Results First Submitted: December 9, 2013
Results First Posted: April 16, 2014
Last Update Posted: July 25, 2018