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Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

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ClinicalTrials.gov Identifier: NCT00921557
Recruitment Status : Completed
First Posted : June 16, 2009
Results First Posted : March 28, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Drug: Alendronate
Drug: Placebo
Dietary Supplement: Calcium carbonate/vitamin D
Enrollment 52
Recruitment Details Fifty-two (52) study participants were recruited between November 5, 2009 and March 27, 2014, at 10 study sites: 8 in the United States and 2 in Brazil.
Pre-assignment Details Children and adolescents were randomly assigned to 3 treatment sequence groups. Two participants were enrolled, but because their baseline lumbar spine bone mineral density z-score was greater than -1.5 at their baseline visit, they never started study treatment and were taken off the study.
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description Participants received alendronate for 96 weeks Participants received alendronate for 48 weeks followed by placebo for 48 weeks Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Period Title: Weeks 0-48 (on Study Treatment)
Started 17 17 18
Completed 15 [1] 17 [1] 18 [1]
Not Completed 2 0 0
Reason Not Completed
Baseline lumbar spine > -1.5             2             0             0
[1]
Completed 48 weeks
Period Title: Weeks 48-96 (on Study Treatment)
Started 15 17 18
Completed 15 16 17
Not Completed 0 1 1
Reason Not Completed
Site Closure             0             1             0
Became a ward of the state             0             0             1
Period Title: Weeks 96-144 (Off Study Treatment)
Started 15 16 17
Completed 12 15 16
Not Completed 3 1 1
Reason Not Completed
Site closure             1             0             0
Not able to attend clinic             2             1             1
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate Total
Hide Arm/Group Description Participants received alendronate for 96 weeks Participants received alendronate for 48 weeks followed by placebo for 48 weeks Participants received placebo for 48 weeks followed by alendronate for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 15 17 18 50
Hide Baseline Analysis Population Description
Includes participants who took at least one dose of study treatment (alendronate/placebo)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 18 participants 50 participants
16
(11 to 23)
16
(12 to 23)
16
(11 to 22)
16
(11 to 23)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
11 - < 15 years Number Analyzed 15 participants 17 participants 18 participants 50 participants
7
  46.7%
4
  23.5%
6
  33.3%
17
  34.0%
15 - < 19 years Number Analyzed 15 participants 17 participants 18 participants 50 participants
6
  40.0%
9
  52.9%
8
  44.4%
23
  46.0%
>= 19 years Number Analyzed 15 participants 17 participants 18 participants 50 participants
2
  13.3%
4
  23.5%
4
  22.2%
10
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 18 participants 50 participants
Female
5
  33.3%
6
  35.3%
5
  27.8%
16
  32.0%
Male
10
  66.7%
11
  64.7%
13
  72.2%
34
  68.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White non-Hispanic Number Analyzed 15 participants 17 participants 18 participants 50 participants
3
  20.0%
3
  17.6%
1
   5.6%
7
  14.0%
Black non-Hispanic Number Analyzed 15 participants 17 participants 18 participants 50 participants
2
  13.3%
4
  23.5%
1
   5.6%
7
  14.0%
Hispanic (regardless of race) Number Analyzed 15 participants 17 participants 18 participants 50 participants
10
  66.7%
10
  58.8%
16
  88.9%
36
  72.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 17 participants 18 participants 50 participants
6
  40.0%
8
  47.1%
7
  38.9%
21
  42.0%
Brazil Number Analyzed 15 participants 17 participants 18 participants 50 participants
9
  60.0%
9
  52.9%
11
  61.1%
29
  58.0%
Tanner stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
1 Number Analyzed 15 participants 17 participants 18 participants 50 participants
1
   6.7%
0
   0.0%
2
  11.1%
3
   6.0%
2 Number Analyzed 15 participants 17 participants 18 participants 50 participants
3
  20.0%
2
  11.8%
2
  11.1%
7
  14.0%
3 Number Analyzed 15 participants 17 participants 18 participants 50 participants
5
  33.3%
1
   5.9%
2
  11.1%
8
  16.0%
4 Number Analyzed 15 participants 17 participants 18 participants 50 participants
1
   6.7%
8
  47.1%
6
  33.3%
15
  30.0%
5 Number Analyzed 15 participants 17 participants 18 participants 50 participants
5
  33.3%
6
  35.3%
6
  33.3%
17
  34.0%
[1]
Measure Description: Tanner stage represents the extent of physical development in children, adolescents and adults. It is based on external physical characteristics such as the size of breasts, genitals and pubic hair. Before puberty children are Tanner 1. Adults are Tanner 5. Study participants were classified as the most advanced stage of breasts and pubic hair (females) and genitals and pubic hair (males).
Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 15 participants 17 participants 18 participants 50 participants
0
   0.0%
2
  11.8%
1
   5.6%
3
   6.0%
No Number Analyzed 15 participants 17 participants 18 participants 50 participants
15
 100.0%
15
  88.2%
17
  94.4%
47
  94.0%
Bone age   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 18 participants 49 participants
14
(10 to 22)
16
(11 to 23)
15
(11 to 21)
15
(10 to 23)
[1]
Measure Analysis Population Description: Bone age estimates maturity of a child's skeletal system. It was assessed by taking an X-ray of the left wrist, hand, and fingers. the X-ray was compared with images in a standard atlas of bone development, based on data from large numbers of other kids of the same gender and age. One participant did not have bone age measured at entry.
Use of tenofovir   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 15 participants 17 participants 18 participants 50 participants
7
  46.7%
7
  41.2%
9
  50.0%
23
  46.0%
No Number Analyzed 15 participants 17 participants 18 participants 50 participants
8
  53.3%
10
  58.8%
9
  50.0%
27
  54.0%
[1]
Measure Description: Tenofovir disoproxil is a drug used to treat HIV
CDC HIV disease category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
A/1 Number Analyzed 15 participants 17 participants 18 participants 50 participants
0
   0.0%
1
   5.9%
3
  16.7%
4
   8.0%
B/2 Number Analyzed 15 participants 17 participants 18 participants 50 participants
2
  13.3%
0
   0.0%
6
  33.3%
8
  16.0%
C/3 Number Analyzed 15 participants 17 participants 18 participants 50 participants
13
  86.7%
16
  94.1%
9
  50.0%
38
  76.0%
[1]
Measure Description: Severity of HIV disease was classified using the Centers for Disease Control (CDC) 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults (https://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm). Disease category C/3 is the most advanced.
HIV-1 RNA (copies/ml)  
Measure Type: Count of Participants
Unit of measure:  Participants
<= 400 Number Analyzed 15 participants 17 participants 18 participants 50 participants
10
  66.7%
16
  94.1%
15
  83.3%
41
  82.0%
>400 Number Analyzed 15 participants 17 participants 18 participants 50 participants
5
  33.3%
1
   5.9%
3
  16.7%
9
  18.0%
CD4 cell count (cells/mm^3)  
Measure Type: Count of Participants
Unit of measure:  Participants
200 - <500 Number Analyzed 15 participants 17 participants 18 participants 50 participants
3
  20.0%
3
  17.6%
2
  11.1%
8
  16.0%
500 - < 1000 Number Analyzed 15 participants 17 participants 18 participants 50 participants
10
  66.7%
10
  58.8%
10
  55.6%
30
  60.0%
>= 1000 Number Analyzed 15 participants 17 participants 18 participants 50 participants
2
  13.3%
4
  23.5%
6
  33.3%
12
  24.0%
25-OH Vitamin D (ng/mL)  
Measure Type: Count of Participants
Unit of measure:  Participants
10 - < 20 Number Analyzed 15 participants 17 participants 18 participants 50 participants
1
   6.7%
5
  29.4%
0
   0.0%
6
  12.0%
20 - < 30 Number Analyzed 15 participants 17 participants 18 participants 50 participants
7
  46.7%
8
  47.1%
6
  33.3%
21
  42.0%
>= 30 Number Analyzed 15 participants 17 participants 18 participants 50 participants
7
  46.7%
4
  23.5%
12
  66.7%
23
  46.0%
Lumbar spine BMD (g/cm^2)  
Median (Full Range)
Unit of measure:  G/cm^2
Number Analyzed 15 participants 17 participants 18 participants 50 participants
0.64
(0.47 to 0.93)
0.73
(0.50 to 0.89)
0.66
(0.50 to 0.88)
0.70
(0.47 to 0.93)
Whole body (with head) BMD (g/cm^2)   [1] 
Median (Full Range)
Unit of measure:  G/cm^2
Number Analyzed 14 participants 16 participants 16 participants 46 participants
0.87
(0.68 to 1.05)
0.91
(0.62 to 1.08)
0.86
(0.69 to 1.08)
0.87
(0.62 to 1.08)
[1]
Measure Analysis Population Description: Whole body (with head) BMD was missing at entry for some participants because of software problems with the DXA machines.
1.Primary Outcome
Title Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD
Hide Description Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks.
Time Frame Weeks 0, 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who started study treatment
Arm/Group Title 1: Alendronate 2: Placebo
Hide Arm/Group Description:
Participants received alendronate for 48 weeks
Participants received placebo for 48 weeks
Overall Number of Participants Analyzed 32 18
Median (95% Confidence Interval)
Unit of Measure: Percent change from baseline
Week 24
14.4
(8.8 to 19.4)
5.5
(1.2 to 7.6)
Week 48
15.9
(9.2 to 25.3)
7.1
(4.9 to 8.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1: Alendronate, 2: Placebo
Comments Comparison of percent change from baseline to week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Not adjusted for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1: Alendronate, 2: Placebo
Comments Comparison of percent change from baseline to week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Not adjusted for multiple comparisons
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures
Hide Description Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.
Time Frame Week 0 to 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title 1: Alendronate 2: Placebo
Hide Arm/Group Description:
Participants received alendronate for 48 weeks
Participants received placebo for 48 weeks
Overall Number of Participants Analyzed 32 18
Measure Type: Count of Participants
Unit of Measure: Participants
5
  15.6%
2
  11.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1: Alendronate, 2: Placebo
Comments Comparison of percentage of participants experiencing primary safety outcome
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments Not adjusted for multiple comparisons
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD
Hide Description Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.
Time Frame Weeks 0, 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who started treatment and had Whole Body (with head) BMD available at week 0
Arm/Group Title 1: Alendronate 2: Placebo
Hide Arm/Group Description:
Participants received alendronate for 48 weeks
Participants received placebo for 48 weeks
Overall Number of Participants Analyzed 30 16
Median (95% Confidence Interval)
Unit of Measure: Percent change from baseline
Week 24 Number Analyzed 30 participants 16 participants
5.5
(3.7 to 8.1)
0.3
(-0.5 to 3.6)
Week 48 Number Analyzed 29 participants 16 participants
10.7
(6.0 to 16.2)
5.2
(1.6 to 8.5)
4.Secondary Outcome
Title Percent Change From Baseline to Week 96 in Lumbar Spine BMD
Hide Description Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.
Time Frame Weeks 0 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who started study treatment and had measurements available at weeks 0 and 96
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Overall Number of Participants Analyzed 14 16
Median (95% Confidence Interval)
Unit of Measure: Percent change from baseline
24.9
(11.1 to 69.8)
14.8
(11.4 to 32.6)
5.Secondary Outcome
Title Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD
Hide Description Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.
Time Frame Weeks 0 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who started study treatment and had measurements available at weeks 0 and 96
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Overall Number of Participants Analyzed 12 14
Median (95% Confidence Interval)
Unit of Measure: Percent change from baseline
19.6
(7.7 to 30.4)
10.3
(5.1 to 24.9)
6.Secondary Outcome
Title Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures
Hide Description Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004).
Time Frame Weeks 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who started treatment
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 15 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 to 48 Number Analyzed 15 participants 17 participants 18 participants
2
  13.3%
3
  17.6%
2
  11.1%
Week 48 to 96 Number Analyzed 15 participants 17 participants 18 participants
1
   6.7%
3
  17.6%
2
  11.1%
Week 96 to 144 Number Analyzed 15 participants 16 participants 17 participants
3
  20.0%
4
  25.0%
3
  17.6%
7.Secondary Outcome
Title Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD
Hide Description A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in lumbar spine BMD from baseline. Results represent average changes in lumbar spine BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.
Time Frame Weeks 0, 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who started study treatment
Arm/Group Title 1: Alendronate 2: Placebo
Hide Arm/Group Description:
Participants received alendronate for 48 weeks
Participants received placebo for 48 weeks
Overall Number of Participants Analyzed 32 18
Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline
Male Number Analyzed 21 participants 13 participants
20.3
(13.0 to 27.6)
6.8
(4.7 to 8.8)
Female Number Analyzed 11 participants 5 participants
25.4
(13.3 to 37.5)
9.4
(-0.1 to 18.9)
Non-hispanic Number Analyzed 12 participants 2 participants
19.4
(7.6 to 31.1)
4.8
(-1.4 to 11.1)
Hispanic Number Analyzed 20 participants 16 participants
23.6
(16.3 to 31.0)
7.8
(5.2 to 10.5)
11 - < 15 years Number Analyzed 11 participants 6 participants
37.1
(27.7 to 46.5)
10.6
(5.6 to 15.7)
15 - < 19 years Number Analyzed 15 participants 8 participants
16.5
(9.6 to 23.4)
8.0
(5.8 to 10.1)
>= 19 years Number Analyzed 6 participants 4 participants
8.1
(-0.7 to 16.9)
1.9
(-4.4 to 8.2)
On Tenofovir Number Analyzed 14 participants 9 participants
24.8
(15.1 to 34.5)
6.8
(3.6 to 10.0)
Not on Tenofovir Number Analyzed 18 participants 9 participants
19.9
(11.6 to 28.2)
8.2
(3.9 to 12.5)
25-OH Vit D<30 ng/ml Number Analyzed 21 participants 6 participants
22.0
(13.5 to 30.4)
6.8
(1.9 to 11.7)
25-0H Vit D>=30 ng/ml Number Analyzed 11 participants 12 participants
22.1
(13.5 to 30.8)
7.8
(4.6 to 11.0)
Bone age < 15 years Number Analyzed 12 participants 9 participants
36.0
(28.1 to 43.9)
10.0
(6.9 to 13.0)
Bone age>=15 years Number Analyzed 19 participants 9 participants
11.3
(7.6 to 15.1)
5.0
(1.6 to 8.4)
Tanner stage <= 3 Number Analyzed 12 participants 6 participants
33.0
(22.7 to 43.3)
10.6
(5.6 to 15.7)
Tanner stage >= 4 Number Analyzed 20 participants 12 participants
15.4
(9.2 to 21.6)
5.9
(3.3 to 8.6)
8.Secondary Outcome
Title Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Whole Body (With Head) BMD.
Hide Description A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in whole body (with head) BMD from baseline. Results represent average changes in whole body (with head) BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.
Time Frame Weeks 0, 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who started study treatment and had Whole Body (with head) available at week 0
Arm/Group Title 1: Alendronate 2: Placebo
Hide Arm/Group Description:
Participants received alendronate for 48 weeks
Participants received placebo for 48 weeks
Overall Number of Participants Analyzed 30 16
Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline
Male Number Analyzed 20 participants 11 participants
11.4
(7.4 to 15.3)
4.1
(1.1 to 7.1)
Female Number Analyzed 10 participants 5 participants
14.0
(6.0 to 22.0)
8.2
(1.6 to 14.7)
Non-Hispanic Number Analyzed 12 participants 2 participants
9.8
(2.7 to 17.0)
0.3
(-4.4 to 4.9)
Hispanic Number Analyzed 18 participants 14 participants
13.9
(10.0 to 17.7)
6.1
(3.3 to 8.9)
11 - < 15 years Number Analyzed 10 participants 6 participants
19.2
(12.9 to 25.5)
8.0
(2.9 to 13.2)
15 - < 19 years Number Analyzed 14 participants 6 participants
10.5
(6.1 to 14.9)
6.5
(3.0 to 10.0)
>= 19 years Number Analyzed 6 participants 4 participants
4.7
(-2.0 to 11.4)
-0.3
(-3.8 to 3.2)
On tenofovir Number Analyzed 12 participants 9 participants
13.2
(7.6 to 18.8)
5.0
(1.5 to 8.6)
Not on tenofovir Number Analyzed 18 participants 7 participants
11.6
(6.7 to 16.5)
5.8
(0.5 to 11.2)
25-0H Vit D<30 ng/ml Number Analyzed 19 participants 5 participants
10.6
(5.6 to 15.6)
5.8
(-2.7 to 14.3)
25-0H Vit D>=30 ng/ml Number Analyzed 11 participants 11 participants
15.1
(10.6 to 19.5)
5.2
(2.3 to 8.0)
Bone age < 15 years Number Analyzed 10 participants 8 participants
19.0
(14.7 to 23.3)
8.4
(4.7 to 12.1)
Bone age >=15 years Number Analyzed 19 participants 8 participants
7.7
(4.1 to 11.2)
2.3
(-0.6 to 5.2)
Tanner stage <= 3 Number Analyzed 10 participants 6 participants
18.0
(10.5 to 25.5)
8.0
(2.9 to 13.2)
Tanner stage >= 4 Number Analyzed 20 participants 10 participants
9.4
(5.9 to 12.8)
3.8
(0.6 to 7.0)
9.Secondary Outcome
Title Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD
Hide Description Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%.
Time Frame Weeks 48, 96 and 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment and had measurements available at the two time points of interest
Arm/Group Title 1B: Alendronate/Placebo (48 Week Change) 2: Placebo/Alendronate (48 Week Change) 1B: Alendronate/Placebo (96 Week Change)
Hide Arm/Group Description:
Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
Overall Number of Participants Analyzed 15 15 15
Median (95% Confidence Interval)
Unit of Measure: Percent change
0.9
(-1.1 to 6.4)
2.0
(-0.6 to 4.6)
1.7
(-1.0 to 6.1)
10.Secondary Outcome
Title Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD
Hide Description Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%.
Time Frame Weeks 48, 96 and 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment and had measurements available at both time points.
Arm/Group Title 1B: Alendronate/Placebo (48 Week Change) 2: Placebo/Alendronate (48 Week Change) 1B: Alendronate/Placebo (96 Week Change)
Hide Arm/Group Description:
Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
Overall Number of Participants Analyzed 15 13 15
Median (95% Confidence Interval)
Unit of Measure: Percent change
0.8
(-1.9 to 3.1)
0.5
(-0.4 to 2.1)
0.9
(0.0 to 5.9)
11.Secondary Outcome
Title Change From Baseline to Week 48 in Bone Marker Turnover
Hide Description Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.
Time Frame Weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Correlation of Changes in Bone Marker Turnover With Changes in Lumbar Spine and Whole Body (With Head) BMD
Hide Description Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.
Time Frame Weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change From Baseline to Week 48 in Receptor Activator of Nuclear Factor Kappa-B Ligand/Osteoprotegerin (RANKL/OPG) Ratio
Hide Description Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.
Time Frame Weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Correlation of Changes in RANKL/OPG Ratio With Changes in Lumbar Spine and Whole Body (With Head) BMD
Hide Description Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.
Time Frame Weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Change From Baseline to Week 48 in Central Fat Content
Hide Description Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.
Time Frame Weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Correlation of Changes in Central Fat Content With Changes in Lumbar Spine and Whole Body (With Head) BMD
Hide Description Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.
Time Frame Weeks 0 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Percent of Participants With HIV-1 RNA <= 400 Copies/ml
Hide Description Percent calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.
Time Frame Weeks 0, 48, 96 and 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who started study treatment.
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 15 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 15 participants 17 participants 18 participants
10
  66.7%
16
  94.1%
15
  83.3%
Week 48 Number Analyzed 15 participants 17 participants 16 participants
10
  66.7%
16
  94.1%
14
  87.5%
Week 96 Number Analyzed 14 participants 15 participants 17 participants
12
  85.7%
12
  80.0%
13
  76.5%
Week 144 Number Analyzed 12 participants 14 participants 16 participants
10
  83.3%
10
  71.4%
10
  62.5%
18.Secondary Outcome
Title Change in CD4 Percent From Baseline
Hide Description Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement
Time Frame Weeks 0, 48, 96 and 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who started study treatment and had CD4 percent available at week 0.
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 15 17 18
Median (95% Confidence Interval)
Unit of Measure: percent of lymphocytes that are CD4 cell
Week 48 - Week 0 Number Analyzed 15 participants 17 participants 17 participants
0
(-3 to 4)
1
(-2 to 3)
1
(-2 to 4)
Week 96 - Week 0 Number Analyzed 14 participants 15 participants 17 participants
0
(-5 to 4)
-1
(-3 to 3)
2
(-4 to 3)
Week 144 - Week 0 Number Analyzed 12 participants 14 participants 16 participants
1
(-9 to 4)
-1
(-3 to 4)
-4
(-5 to 8)
19.Secondary Outcome
Title Change in Centers for Disease Control (CDC) HIV Disease Category
Hide Description Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up
Time Frame Weeks 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who started study treatment.
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 15 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 to 48 Number Analyzed 15 participants 17 participants 18 participants
1
   6.7%
0
   0.0%
0
   0.0%
Week 48 to 96 Number Analyzed 15 participants 17 participants 18 participants
0
   0.0%
1
   5.9%
0
   0.0%
Week 96 to 144 Number Analyzed 15 participants 16 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
20.Secondary Outcome
Title Percent of Participants With Detectable Urinary Alendronate
Hide Description Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.
Time Frame Weeks 48, 96 and 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description:
Participants received alendronate for 96 weeks
Participants received alendronate for 48 weeks followed by placebo for 48 weeks
Participants received placebo for 48 weeks followed by alendronate for 48 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From first dose of study treatment to end of follow-up (144 weeks)
Adverse Event Reporting Description Expedited adverse event (EAE) reporting followed the DAIDS EAE Manual under the SAE Reporting Category and including fetal losses. Events were graded (1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death) according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Clarification Aug 2009. Reports are summarized by randomized arm for consistency with outcomes and because effects of alendronate can continue for months after stopping the drug.
 
Arm/Group Title 1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Hide Arm/Group Description Participants received alendronate for 48 weeks Participants received alendronate for 48 weeks followed by placebo for 48 weeks Participants received placebo for 48 weeks followed by alendronate for 48 weeks
All-Cause Mortality
1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%)   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/15 (13.33%)   2/17 (11.76%)   3/18 (16.67%) 
Blood and lymphatic system disorders       
Neutropenia  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Infections and infestations       
Pneumonia  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Pneumonia bacterial  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Tuberculosis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Burkitt's lymphoma  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Nervous system disorders       
Epilepsy  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
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 5%
1A: Alendronate/Alendronate 1B: Alendronate/Placebo 2: Placebo/Alendronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   17/17 (100.00%)   18/18 (100.00%) 
Blood and lymphatic system disorders       
Lymph node pain  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Lymphadenitis  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Cardiac disorders       
Bradycardia  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Left ventricular hypertrophy  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Palpitations  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Sinus bradycardia  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Tachycardia  1  0/15 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
Ventricular extrasystoles  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders       
Deafness  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Ear congestion  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Ear pain  1  0/15 (0.00%)  2/17 (11.76%)  0/18 (0.00%) 
Otorrhoea  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Eye disorders       
Conjunctival hyperaemia  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Eye pain  1  1/15 (6.67%)  1/17 (5.88%)  1/18 (5.56%) 
Myopia  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Vision blurred  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Abdominal pain  1  3/15 (20.00%)  1/17 (5.88%)  2/18 (11.11%) 
Abdominal pain lower  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Abdominal pain upper  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Aphthous ulcer  1  1/15 (6.67%)  1/17 (5.88%)  0/18 (0.00%) 
Dental caries  1  0/15 (0.00%)  0/17 (0.00%)  3/18 (16.67%) 
Diarrhoea  1  2/15 (13.33%)  0/17 (0.00%)  1/18 (5.56%) 
Dyspepsia  1  1/15 (6.67%)  3/17 (17.65%)  3/18 (16.67%) 
Dysphagia  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Food poisoning  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Gastritis  1  1/15 (6.67%)  1/17 (5.88%)  1/18 (5.56%) 
Gastrooesophageal reflux disease  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Gingival pain  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Gingival recession  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Haematochezia  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Intestinal haemorrhage  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Lip blister  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Lip ulceration  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Nausea  1  2/15 (13.33%)  0/17 (0.00%)  0/18 (0.00%) 
Necrotising colitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Noninfective gingivitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Odynophagia  1  0/15 (0.00%)  1/17 (5.88%)  2/18 (11.11%) 
Oesophagitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Oral pain  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Proctalgia  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Stomatitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Tooth discolouration  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Toothache  1  0/15 (0.00%)  1/17 (5.88%)  7/18 (38.89%) 
Vomiting  1  2/15 (13.33%)  2/17 (11.76%)  0/18 (0.00%) 
General disorders       
Chest pain  1  3/15 (20.00%)  1/17 (5.88%)  4/18 (22.22%) 
Fatigue  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Gait disturbance  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Local swelling  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Malaise  1  1/15 (6.67%)  0/17 (0.00%)  1/18 (5.56%) 
Pain  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Peripheral swelling  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Pyrexia  1  3/15 (20.00%)  1/17 (5.88%)  3/18 (16.67%) 
Systemic inflammatory response syndrome  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Infections and infestations       
Acarodermatitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Bronchitis  1  0/15 (0.00%)  2/17 (11.76%)  1/18 (5.56%) 
Cellulitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Conjunctivitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Cytomegalovirus oesophagitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Dengue fever  1  1/15 (6.67%)  2/17 (11.76%)  2/18 (11.11%) 
Escherichia sepsis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Escherichia urinary tract infection  1  0/15 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
Flea infestation  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Gastroenteritis  1  1/15 (6.67%)  1/17 (5.88%)  1/18 (5.56%) 
Gingivitis  1  1/15 (6.67%)  4/17 (23.53%)  3/18 (16.67%) 
Herpes simplex  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Herpes zoster  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Impetigo  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Latent tuberculosis  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Lice infestation  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Molluscum contagiosum  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Ophthalmic herpes simplex  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Oral candidiasis  1  0/15 (0.00%)  0/17 (0.00%)  3/18 (16.67%) 
Oral herpes  1  2/15 (13.33%)  1/17 (5.88%)  1/18 (5.56%) 
Otitis externa  1  0/15 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
Otitis media  1  1/15 (6.67%)  3/17 (17.65%)  2/18 (11.11%) 
Otitis media chronic  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Pharyngitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Pneumocystis jirovecii pneumonia  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Pneumonia  1  0/15 (0.00%)  2/17 (11.76%)  0/18 (0.00%) 
Pneumonia bacterial  1  1/15 (6.67%)  1/17 (5.88%)  1/18 (5.56%) 
Pneumonia staphylococcal  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Pulmonary tuberculosis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Scarlet fever  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Septic shock  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Sinusitis bacterial  1  2/15 (13.33%)  2/17 (11.76%)  3/18 (16.67%) 
Subcutaneous abscess  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Tinea infection  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Tinea versicolour  1  2/15 (13.33%)  2/17 (11.76%)  1/18 (5.56%) 
Tonsillitis  1  2/15 (13.33%)  0/17 (0.00%)  2/18 (11.11%) 
Tooth abscess  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Upper respiratory tract infection  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Urinary tract infection bacterial  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Viral infection  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Vulvovaginitis  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Injury, poisoning and procedural complications       
Arthropod sting  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Burns first degree  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Contusion  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Hand fracture  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Laceration  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Ligament sprain  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Procedural pain  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Tooth fracture  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Investigations       
Alanine aminotransferase  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Alanine aminotransferase increased  1  0/15 (0.00%)  2/17 (11.76%)  3/18 (16.67%) 
Aspartate aminotransferase  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Aspartate aminotransferase increased  1  0/15 (0.00%)  3/17 (17.65%)  2/18 (11.11%) 
Blood albumin decreased  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Blood alkaline phosphatase abnormal  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Blood alkaline phosphatase increased  1  6/15 (40.00%)  2/17 (11.76%)  4/18 (22.22%) 
Blood bicarbonate decreased  1  2/15 (13.33%)  4/17 (23.53%)  4/18 (22.22%) 
Blood bilirubin increased  1  2/15 (13.33%)  4/17 (23.53%)  6/18 (33.33%) 
Blood calcium decreased  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Blood calcium increased  1  3/15 (20.00%)  1/17 (5.88%)  0/18 (0.00%) 
Blood cholesterol increased  1  1/15 (6.67%)  2/17 (11.76%)  1/18 (5.56%) 
Blood creatinine increased  1  1/15 (6.67%)  2/17 (11.76%)  4/18 (22.22%) 
Blood glucose decreased  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Blood glucose increased  1  1/15 (6.67%)  1/17 (5.88%)  2/18 (11.11%) 
Blood pH decreased  1  2/15 (13.33%)  1/17 (5.88%)  2/18 (11.11%) 
Blood phosphorus decreased  1  4/15 (26.67%)  3/17 (17.65%)  4/18 (22.22%) 
Blood potassium decreased  1  0/15 (0.00%)  1/17 (5.88%)  2/18 (11.11%) 
Blood sodium decreased  1  5/15 (33.33%)  2/17 (11.76%)  7/18 (38.89%) 
Blood sodium increased  1  0/15 (0.00%)  2/17 (11.76%)  2/18 (11.11%) 
Blood uric acid increased  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Haemoglobin decreased  1  0/15 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
Heart rate irregular  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Lipase abnormal  1  1/15 (6.67%)  1/17 (5.88%)  1/18 (5.56%) 
Low density lipoprotein increased  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Neutrophil count decreased  1  2/15 (13.33%)  2/17 (11.76%)  6/18 (33.33%) 
Platelet count decreased  1  2/15 (13.33%)  2/17 (11.76%)  1/18 (5.56%) 
Prothrombin time abnormal  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Weight decreased  1  0/15 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
White blood cell count decreased  1  0/15 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
Metabolism and nutrition disorders       
Body fat disorder  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Lactic acidosis  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Malnutrition  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/15 (13.33%)  4/17 (23.53%)  8/18 (44.44%) 
Back pain  1  0/15 (0.00%)  1/17 (5.88%)  2/18 (11.11%) 
Bone pain  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Flank pain  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Kyphosis  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Musculoskeletal chest pain  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Myalgia  1  6/15 (40.00%)  4/17 (23.53%)  4/18 (22.22%) 
Pain in extremity  1  0/15 (0.00%)  3/17 (17.65%)  3/18 (16.67%) 
Pain in jaw  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Temporomandibular joint syndrome  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lipoma  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Penile wart  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Skin papilloma  1  1/15 (6.67%)  0/17 (0.00%)  2/18 (11.11%) 
Nervous system disorders       
Dizziness  1  1/15 (6.67%)  1/17 (5.88%)  3/18 (16.67%) 
Headache  1  3/15 (20.00%)  2/17 (11.76%)  2/18 (11.11%) 
Loss of consciousness  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Migraine  1  1/15 (6.67%)  0/17 (0.00%)  2/18 (11.11%) 
Seizure  1  1/15 (6.67%)  0/17 (0.00%)  1/18 (5.56%) 
Tremor  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Pregnancy, puerperium and perinatal conditions       
Abortion early  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Abortion spontaneous  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Pregnancy  1  1/15 (6.67%)  1/17 (5.88%)  0/18 (0.00%) 
Psychiatric disorders       
Attention deficit/hyperactivity disorder  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Major depression  1  0/15 (0.00%)  2/17 (11.76%)  1/18 (5.56%) 
Substance abuse  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Suicidal ideation  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Renal and urinary disorders       
Dysuria  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Nephrolithiasis  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Renal tubular dysfunction  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Urethral stenosis  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Reproductive system and breast disorders       
Balanoposthitis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Dysmenorrhoea  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Gynaecomastia  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Pelvic pain  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Penile pain  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Polycystic ovaries  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchiectasis  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Cough  1  2/15 (13.33%)  2/17 (11.76%)  2/18 (11.11%) 
Dyspnoea  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Nasal congestion  1  1/15 (6.67%)  1/17 (5.88%)  1/18 (5.56%) 
Nasal polyps  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Nasal pruritus  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Pharyngeal inflammation  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Pharyngeal ulceration  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Pulmonary pain  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Rhinorrhoea  1  2/15 (13.33%)  0/17 (0.00%)  1/18 (5.56%) 
Sinus congestion  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne  1  2/15 (13.33%)  2/17 (11.76%)  1/18 (5.56%) 
Alopecia  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Blister  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Drug eruption  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
Erythema  1  0/15 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Lichen planus  1  0/15 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Lipoatrophy  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Macule  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Papule  1  1/15 (6.67%)  0/17 (0.00%)  1/18 (5.56%) 
Pityriasis alba  1  2/15 (13.33%)  0/17 (0.00%)  0/18 (0.00%) 
Pruritus generalised  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Vascular disorders       
Hypotension  1  0/15 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Varicose vein  1  1/15 (6.67%)  0/17 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Results Point of Contact
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00921557     History of Changes
Other Study ID Numbers: P1076
10669 ( Registry Identifier: DAIDS-ES Registry Number )
IMPAACT P1076
First Submitted: June 12, 2009
First Posted: June 16, 2009
Results First Submitted: December 15, 2016
Results First Posted: March 28, 2017
Last Update Posted: July 21, 2017