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Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV) (BLIR-HIV)

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ClinicalTrials.gov Identifier: NCT01228318
Recruitment Status : Completed
First Posted : October 26, 2010
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ighovwerha Ofotokun, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions HIV Infection
Bone Loss
Osteopenia
Osteoporosis
Intervention Drug: Zoledronic acid
Enrollment 63
Recruitment Details At the Grady Hospital Infectious Disease Clinic 343 subjects were assessed for eligibility and 280 were excluded. 63 viremic treatment-naïve adult HIV-infected subjects were randomized in a double-blinded, placebo-controlled study (ART+placebo N=29; ART+Zoledronic acid N=34). Participants were enrolled between January 2011 and August 2014.
Pre-assignment Details  
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description

Participants in this arm received a 5 milligrams (mg)/100 milliliter (mL) solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.

Study visits occurred at 12, 24, 48, 96, and 144 weeks.

Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel.

Study visits occurred at 12, 24, 48, 96, and 144 weeks.

Period Title: Overall Study
Started 34 29
Completed 30 22
Not Completed 4 7
Reason Not Completed
Clinic no show to receive intervention             1             0
Unable to contact             2             5
Moved             0             2
Incarcerated             1             0
Arm/Group Title Zoledronic Acid Placebo Total
Hide Arm/Group Description Participants in this arm received a 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel. Total of all reporting groups
Overall Number of Baseline Participants 34 29 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 29 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
29
 100.0%
63
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 29 participants 63 participants
Female
27
  79.4%
23
  79.3%
50
  79.4%
Male
7
  20.6%
6
  20.7%
13
  20.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 29 participants 63 participants
Hispanic or Latino
2
   5.9%
0
   0.0%
2
   3.2%
Not Hispanic or Latino
32
  94.1%
29
 100.0%
61
  96.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 29 participants 63 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
27
  79.4%
26
  89.7%
53
  84.1%
White
7
  20.6%
3
  10.3%
10
  15.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 29 participants 63 participants
34 29 63
Body Mass Index (BMI)  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 34 participants 29 participants 63 participants
24.4
(18.9 to 41.2)
23.8
(16.9 to 38.7)
23.8
(16.9 to 41.2)
Cluster of differentiation 4 (CD4) T-cell count  
Median (Full Range)
Unit of measure:  cells/uL
Number Analyzed 34 participants 29 participants 63 participants
91.5
(5 to 239)
117
(3 to 574)
101
(3 to 574)
HIV-1 Viral Load  
Median (Full Range)
Unit of measure:  Log10 copies/ml
Number Analyzed 34 participants 29 participants 63 participants
4.97
(3.69 to 6.44)
4.93
(2.51 to 6.06)
4.96
(2.51 to 6.44)
Weight  
Median (Full Range)
Unit of measure:  Kilograms
Number Analyzed 34 participants 29 participants 63 participants
72.9
(49.8 to 118.2)
73.3
(54.9 to 107.2)
73.3
(49.8 to 118.2)
Age  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 29 participants 63 participants
38
(30 to 50)
37
(30 to 51)
38
(30 to 51)
Height  
Median (Full Range)
Unit of measure:  Inches
Number Analyzed 34 participants 29 participants 63 participants
69
(61 to 76)
70
(61 to 77)
70
(61 to 77)
1.Primary Outcome
Title Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels
Hide Description Serum C-terminal telopeptide of collagen (CTx) levels through week 144 were examined by evaluating the baseline-adjusted means. The baseline-adjusted CTx mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at each scheduled clinical visit. The expected outcome is that HIV-infected individuals will display increased indices of bone resorption (CTx) as a result of diminished bone mineral density (BMD). Lower CTx values indicate that better maintenance of bone mineral density.
Time Frame Baseline, Week 12 through Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with CTx measurements at the indicated week are included in this analysis.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:

Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Overall Number of Participants Analyzed 31 26
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ng/ml
Week 12 Number Analyzed 30 participants 26 participants
0.092
(0.040 to 0.145)
0.297
(0.240 to 0.353)
Week 24 Number Analyzed 31 participants 25 participants
0.122
(0.074 to 0.171)
0.331
(0.276 to 0.384)
Week 48 Number Analyzed 28 participants 24 participants
0.122
(0.077 to 0.168)
0.264
(0.215 to 0.313)
Week 72 Number Analyzed 25 participants 22 participants
0.138
(0.088 to 0.189)
0.242
(0.188 to 0.296)
Week 96 Number Analyzed 23 participants 23 participants
0.126
(0.042 to 0.209)
0.321
(0.238 to 0.404)
Week 120 Number Analyzed 20 participants 20 participants
0.137
(0.088 to 0.187)
0.201
(0.151 to 0.250)
Week 144 Number Analyzed 21 participants 20 participants
0.148
(0.096 to 0.200)
0.200
(0.147 to 0.254)
2.Secondary Outcome
Title Baseline-Adjusted Means of Osteocalcin
Hide Description Osteocalcin was evaluated to examine the inhibitory effect of single dose zoledronic acid on HAART associated changes in markers of bone turnover. Osteocalcin is released from bone during resorption and higher levels in the circulatory system indicate increased bone turnover. HIV-infected individuals are expected to have increased bone resorption. The baseline-adjusted osteocalcin mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Baseline-adjusted means of osteocalcin at week 144 are presented.
Time Frame Baseline, Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with osteocalcin measurements at Week 144 are included in this analysis.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:

Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Overall Number of Participants Analyzed 21 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ng/ml
9.176
(4.557 to 13.796)
13.597
(8.862 to 18.332)
3.Other Pre-specified Outcome
Title Baseline-Adjusted Means of Dual-energy X-ray Absorptiometry (DXA)
Hide Description Development of osteoporosis was assessed by examining bone mineral density (BMD) by DXA scan. Baseline-adjusted means of DXA scan Z-scores are presented for the lumbar spine (L1-L4), left hip, and femur neck. The baseline-adjusted BMD mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Bone density Z-scores tell how close to the average that a person is (adjusted for age, race, and gender). A Z-score of 0 means the value matches that of the average person. Z-score values below 0 indicate lower than average bone density while values above 0 indicate higher bone density than the average person.
Time Frame Baseline, Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants who had a DXA scan performed at baseline and at least one additional study visit.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:

Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Overall Number of Participants Analyzed 29 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Z score
Lumbar Spine
-0.177
(-0.371 to 0.016)
-0.836
(-1.062 to -0.609)
Hip
-0.860
(-0.992 to -0.728)
-1.092
(-1.246 to -0.938)
Femoral Neck
-0.665
(-0.833 to -0.498)
-0.817
(-1.012 to -0.622)
4.Post-Hoc Outcome
Title Percentage of Participants With Virological Suppression by Week 144
Hide Description The percentage of participants achieving viral load suppression by study week 144. Virologic suppression was defined as HIV RNA polymerase chain reaction (PCR) (viral loads) less than 50 copies per mL.
Time Frame Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants are included in this analysis, using all available measurements of viral load.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:

Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Overall Number of Participants Analyzed 34 29
Measure Type: Number
Unit of Measure: percentage of participants
91 100
5.Post-Hoc Outcome
Title CD4 T Cell Count
Hide Description Immunologic response measured by CD4 T cell count by treatment arm and weeks on study.
Time Frame Baseline, Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants with a CD4 count measurement at the time points indicated.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:

Subjects in this arm will receive 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Subjects in the placebo arm will receive placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered iv over 15-30 minutes under the supervision of study personnel.

Zoledronic acid: a. A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.

b. A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes.

Overall Number of Participants Analyzed 34 29
Mean (Standard Deviation)
Unit of Measure: cells/uL
Baseline Number Analyzed 34 participants 29 participants
102  (69) 155  (145)
Week 144 Number Analyzed 31 participants 22 participants
347  (27) 439  (52)
Time Frame Adverse effects elicited from the BLIR patient at each scheduled visit (12, 24, 48, 96, and 144 weeks) using the Case Report Form Checklist of 36 HAART Signs and Symptoms. Participants were also volunteered complaints of side effects that were outside of the checklist.
Adverse Event Reporting Description The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the ClinicalTrials.gov definitions.
 
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description Participants in this arm received a 5mg/100mL solution of zoledronic acid infused intravenously over 15-30 minutes under the supervision of study personnel. Participants in the placebo arm received a placebo to match the study drug, containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution administered intravenously over 15-30 minutes under the supervision of study personnel.
All-Cause Mortality
Zoledronic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zoledronic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/34 (20.59%)      6/29 (20.69%)    
Endocrine disorders     
Hospitalization due to pancreatitis *  1/34 (2.94%)  1 0/29 (0.00%)  0
Hospitalization related to Graves' Disease *  0/34 (0.00%)  0 1/29 (3.45%)  3
Gastrointestinal disorders     
Hospitalization due to gastro esphageal reflux disease * [1]  1/34 (2.94%)  1 0/29 (0.00%)  0
General disorders     
Hospitalization due to abdominal pain * [2]  1/34 (2.94%)  1 0/29 (0.00%)  0
Hospitalization * [3]  1/34 (2.94%)  1 0/29 (0.00%)  0
Infections and infestations     
Hospitalization due to neurosyphilis *  1/34 (2.94%)  1 0/29 (0.00%)  0
Psychiatric disorders     
Psychiatric hospitalization * [4]  0/34 (0.00%)  0 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders     
Hospitalization due to community acquired pneumonia *  1/34 (2.94%)  1 3/29 (10.34%)  3
Hospitalization due to brochitis and otitis externa *  1/34 (2.94%)  1 0/29 (0.00%)  0
Vascular disorders     
Hospitalization due to sub-acute cerebrovascular accident *  0/34 (0.00%)  0 1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant was admitted due to chest pain and abnormal electrocardiogram; cardiac tests were normal and gastro esophageal reflux disease was diagnosed
[2]
Participant was hospitalized with complaints of abdominal pain and was discharged after being observed for 24 hours.
[3]
Participant was admitted with multiple diagnoses that were unrelated to study treatment
[4]
Participant admitted to psychiatric unit due to homicidal intentions against family member. This event is considered unrelated to study treatment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zoledronic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/34 (100.00%)      28/29 (96.55%)    
Blood and lymphatic system disorders     
Lower extremity edema *  2/34 (5.88%)  4 1/29 (3.45%)  1
Ear and labyrinth disorders     
Tinnitus *  2/34 (5.88%)  15 2/29 (6.90%)  9
Pain in right ear *  1/34 (2.94%)  1 1/29 (3.45%)  1
Decreased hearing/ear stopped up *  2/34 (5.88%)  4 0/29 (0.00%)  0
Eye disorders     
Itchy/watery eye *  1/34 (2.94%)  1 3/29 (10.34%)  7
Seeing spots *  0/34 (0.00%)  0 2/29 (6.90%)  4
Gastrointestinal disorders     
Diarrhea   26/34 (76.47%)  113 18/29 (62.07%)  69
Flatulence   24/34 (70.59%)  128 13/29 (44.83%)  91
Dyspepsia   16/34 (47.06%)  42 13/29 (44.83%)  34
Vomiting   10/34 (29.41%)  20 10/29 (34.48%)  20
Dysphagia   7/34 (20.59%)  29 8/29 (27.59%)  25
Bloody stool *  2/34 (5.88%)  3 0/29 (0.00%)  0
Bitter mouth taste *  2/34 (5.88%)  9 0/29 (0.00%)  0
Constipation *  1/34 (2.94%)  2 0/29 (0.00%)  0
General disorders     
Fatigue   28/34 (82.35%)  176 22/29 (75.86%)  145
Night sweats   26/34 (76.47%)  87 15/29 (51.72%)  56
Headache   26/34 (76.47%)  110 15/29 (51.72%)  81
Numbness/tingling   27/34 (79.41%)  156 13/29 (44.83%)  114
Decreased libido   24/34 (70.59%)  127 15/29 (51.72%)  92
Weight loss   21/34 (61.76%)  46 15/29 (51.72%)  42
Loss of appetite   20/34 (58.82%)  66 15/29 (51.72%)  63
Insomnia   21/34 (61.76%)  140 14/29 (48.28%)  90
Myalgias   20/34 (58.82%)  99 15/29 (51.72%)  89
Arthralgias   18/34 (52.94%)  71 17/29 (58.62%)  105
Flulike symptoms   18/34 (52.94%)  31 13/29 (44.83%)  19
Fever   15/34 (44.12%)  26 15/29 (51.72%)  22
Chills   17/34 (50.00%)  29 13/29 (44.83%)  27
Nausea   17/34 (50.00%)  55 13/29 (44.83%)  45
Blurred vision   17/34 (50.00%)  76 12/29 (41.38%)  93
Loss of memory   15/34 (44.12%)  99 12/29 (41.38%)  83
Abdominal pain   13/34 (38.24%)  36 9/29 (31.03%)  45
Motor weakness   11/34 (32.35%)  32 9/29 (31.03%)  78
Asthenia   10/34 (29.41%)  33 9/29 (31.03%)  62
Oral pain   8/34 (23.53%)  16 6/29 (20.69%)  20
Photophobia   4/34 (11.76%)  18 10/29 (34.48%)  37
Bone pain   6/34 (17.65%)  28 5/29 (17.24%)  30
Odynophagia   1/34 (2.94%)  1 1/29 (3.45%)  1
Dizziness *  5/34 (14.71%)  10 4/29 (13.79%)  12
Back pain *  7/34 (20.59%)  36 5/29 (17.24%)  19
Tooth ache *  3/34 (8.82%)  46 4/29 (13.79%)  42
Generalized muscle pain *  2/34 (5.88%)  3 2/29 (6.90%)  9
Left eye twitching *  2/34 (5.88%)  2 1/29 (3.45%)  3
Dry mouth *  0/34 (0.00%)  0 2/29 (6.90%)  7
Intermittent nose bleed *  2/34 (5.88%)  3 0/29 (0.00%)  0
Throat pain *  0/34 (0.00%)  0 2/29 (6.90%)  2
Abdominal tenderness *  0/34 (0.00%)  0 1/29 (3.45%)  2
Anal pain *  1/34 (2.94%)  1 0/29 (0.00%)  0
Flank pain *  3/34 (8.82%)  8 0/29 (0.00%)  0
Bloating *  0/34 (0.00%)  0 1/29 (3.45%)  1
Bruising easily *  0/34 (0.00%)  0 1/29 (3.45%)  1
Bump inside mouth *  0/34 (0.00%)  0 1/29 (3.45%)  1
Easily distracted *  1/34 (2.94%)  7 0/29 (0.00%)  0
Entire body heat *  1/34 (2.94%)  1 0/29 (0.00%)  0
General body aches *  0/34 (0.00%)  0 1/29 (3.45%)  1
Hair thinning *  0/34 (0.00%)  0 1/29 (3.45%)  2
Hotflashes *  2/34 (5.88%)  12 0/29 (0.00%)  0
Left sided weakness *  0/34 (0.00%)  0 1/29 (3.45%)  2
Numbness (hands, legs, body) *  3/34 (8.82%)  4 1/29 (3.45%)  1
Loss of balance *  0/34 (0.00%)  0 1/29 (3.45%)  1
Right facial swelling *  0/34 (0.00%)  0 1/29 (3.45%)  1
Right side weakness *  0/34 (0.00%)  0 1/29 (3.45%)  9
Salivation *  1/34 (2.94%)  8 0/29 (0.00%)  0
Stomach feels tight *  1/34 (2.94%)  3 0/29 (0.00%)  0
Infections and infestations     
Oral thrush   9/34 (26.47%)  11 6/29 (20.69%)  14
Pain from shingles *  2/34 (5.88%)  6 1/29 (3.45%)  3
Boil left buttock *  0/34 (0.00%)  0 1/29 (3.45%)  1
Herpes outbreak *  0/34 (0.00%)  0 2/29 (6.90%)  4
Hordeolum *  1/34 (2.94%)  1 0/29 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle cramps (hands, feet, legs) *  5/34 (14.71%)  8 1/29 (3.45%)  1
Foot pain *  1/34 (2.94%)  2 3/29 (10.34%)  5
Ankle tenderness/pain *  1/34 (2.94%)  3 1/29 (3.45%)  1
Arm pain *  2/34 (5.88%)  2 0/29 (0.00%)  0
Bone pain in left hand *  1/34 (2.94%)  1 0/29 (0.00%)  0
Knee swollen *  0/34 (0.00%)  0 1/29 (3.45%)  1
Lower left leg pain *  0/34 (0.00%)  0 1/29 (3.45%)  1
Muscle spasms *  0/34 (0.00%)  0 1/29 (3.45%)  1
Neck pain/stiffness *  1/34 (2.94%)  1 3/29 (10.34%)  11
Pain in right knee *  1/34 (2.94%)  1 0/29 (0.00%)  0
Right shoulder discomfort *  0/34 (0.00%)  0 1/29 (3.45%)  1
Right wrist pain *  1/34 (2.94%)  1 0/29 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Kaposi sarcoma   2/34 (5.88%)  10 0/29 (0.00%)  0
Psychiatric disorders     
Depression   21/34 (61.76%)  150 16/29 (55.17%)  131
Anxiety *  1/34 (2.94%)  6 1/29 (3.45%)  4
Hearing voices *  0/34 (0.00%)  0 1/29 (3.45%)  5
Renal and urinary disorders     
Bladder spasms *  0/34 (0.00%)  0 1/29 (3.45%)  2
Dark urine *  1/34 (2.94%)  4 0/29 (0.00%)  0
Frequent urination *  1/34 (2.94%)  3 0/29 (0.00%)  0
Urinary retention *  1/34 (2.94%)  4 0/29 (0.00%)  0
Urinary urgency *  0/34 (0.00%)  0 1/29 (3.45%)  1
Reproductive system and breast disorders     
Groin pain *  2/34 (5.88%)  3 0/29 (0.00%)  0
Erectile dysfunction *  1/34 (2.94%)  1 0/29 (0.00%)  0
Pelvic pain *  1/34 (2.94%)  1 1/29 (3.45%)  1
Testicular pain *  0/34 (0.00%)  0 1/29 (3.45%)  3
Vaginal itching *  0/34 (0.00%)  0 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   28/34 (82.35%)  141 22/29 (75.86%)  79
Nasal/sinus drainage   28/34 (82.35%)  141 22/29 (75.86%)  79
Shortness of breath   20/34 (58.82%)  101 13/29 (44.83%)  94
Bronchitis   5/34 (14.71%)  5 6/29 (20.69%)  9
Sore throat *  3/34 (8.82%)  3 5/29 (17.24%)  6
Chest pain *  4/34 (11.76%)  4 3/29 (10.34%)  8
Burning in chest with excertion *  0/34 (0.00%)  0 1/29 (3.45%)  1
Congestion *  1/34 (2.94%)  1 1/29 (3.45%)  2
Dry throat *  0/34 (0.00%)  0 1/29 (3.45%)  1
Wheezing *  1/34 (2.94%)  1 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash (head, shoulder, feet)   21/34 (61.76%)  90 18/29 (62.07%)  76
Dark spots *  3/34 (8.82%)  10 0/29 (0.00%)  0
Dry skin *  3/34 (8.82%)  5 0/29 (0.00%)  0
Facial acne *  1/34 (2.94%)  1 0/29 (0.00%)  0
Psoriasis *  2/34 (5.88%)  2 0/29 (0.00%)  0
Rash left forehead *  0/34 (0.00%)  0 1/29 (3.45%)  1
Scalp pruritus *  0/34 (0.00%)  0 1/29 (3.45%)  1
Welts when skin scratched *  2/34 (5.88%)  10 0/29 (0.00%)  0
Vascular disorders     
Vein distended   2/34 (5.88%)  15 3/29 (10.34%)  17
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
This single site proof-of-concept phase 2b study had a small sample size & a 144-week study duration so it could not evaluate the impact of the intervention on long-term bone outcomes. The population enrolled limited the generalization of findings.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Igho Ofotokun, MD, MSc
Organization: Emory University
Phone: 404-616-0659
Responsible Party: Ighovwerha Ofotokun, Emory University
ClinicalTrials.gov Identifier: NCT01228318     History of Changes
Other Study ID Numbers: IRB00038739
BLIR-HIV ( Other Identifier: Other )
First Submitted: October 23, 2010
First Posted: October 26, 2010
Results First Submitted: March 27, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018