Trial Outcomes & Findings for Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults (NCT NCT00119379)
NCT ID: NCT00119379
Last Updated: 2017-06-07
Results Overview
Subcutaneous abdominal fat mitochondrial DNA (mtDNA)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline to Week 48
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Uridine Supplementation
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Uridine Supplementation
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
Baseline Characteristics
Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults
Baseline characteristics by cohort
| Measure |
Uridine Supplementation
n=26 Participants
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 Participants
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
n=5 Participants
|
48 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 48Subcutaneous abdominal fat mitochondrial DNA (mtDNA)
Outcome measures
| Measure |
Uridine Supplementation
n=26 Participants
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 Participants
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Change in Fat mtDNA Content
|
-169 copies/cell
Interval -778.0 to 64.0
|
321 copies/cell
Interval -298.0 to 669.0
|
PRIMARY outcome
Timeframe: Baseline to Week 48Peripheral blood mononuclear cell (PBMC) mitochondrial DNA (mtDNA), measured in copies/cell
Outcome measures
| Measure |
Uridine Supplementation
n=26 Participants
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 Participants
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Change in PBMC mtDNA
|
-24 copies/cell
Interval -158.0 to 91.0
|
-52 copies/cell
Interval -105.0 to 108.0
|
SECONDARY outcome
Timeframe: Baseline to Week 48Change in limb fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan
Outcome measures
| Measure |
Uridine Supplementation
n=26 Participants
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 Participants
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Change in Limb Fat
|
0.1 limb fat (kg)
Interval -0.03 to 0.3
|
0.4 limb fat (kg)
Interval -0.06 to 1.2
|
SECONDARY outcome
Timeframe: Baseline to Week 48Change in trunk fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan
Outcome measures
| Measure |
Uridine Supplementation
n=26 Participants
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 Participants
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Change in Trunk Fat
|
0.2 trunk fat (kg)
Interval -0.5 to 0.6
|
0.7 trunk fat (kg)
Interval -0.04 to 1.4
|
SECONDARY outcome
Timeframe: Baseline to Week 48Change in lumbar spine bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan
Outcome measures
| Measure |
Uridine Supplementation
n=26 Participants
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 Participants
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Change in Lumbar Spine Bone Mineral Density (BMD)
|
0.39 lumbar spine BMD, g/cm^2
Interval -0.96 to 1.68
|
0.0 lumbar spine BMD, g/cm^2
Interval -2.9 to 1.76
|
SECONDARY outcome
Timeframe: Baseline to Week 48Change in hip bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan
Outcome measures
| Measure |
Uridine Supplementation
n=26 Participants
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 Participants
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Change in Hip Bone Mineral Density (BMD)
|
0.45 hip BMD, g/cm^2
Interval -0.27 to 3.56
|
-3.3 hip BMD, g/cm^2
Interval -5.1 to 0.0
|
Adverse Events
Uridine Supplementation
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Switch to TDF
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Uridine Supplementation
n=26 participants at risk
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 participants at risk
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia Gr. 3
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Abnormal phos. Gr. 3
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 3 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Renal calculus Gr. 3
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Musculoskeletal and connective tissue disorders
Elevated CK Gr. 3 & 4
|
7.7%
2/26 • Number of events 3 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
12.5%
3/24 • Number of events 4 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Endocrine disorders
Pancreatitis Gr. 3
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Ear and labyrinth disorders
Vertigo Gr. 3
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Cardiac disorders
Hypercholesterolem Gr. 3
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Gastrointestinal disorders
Diarrhea Gr. 3
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Hypertrigliceridemia Gr. 3 & 4
|
7.7%
2/26 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Abnormal AST Gr. 3
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Renal and urinary disorders
Dysuria Gr. 3
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
Other adverse events
| Measure |
Uridine Supplementation
n=26 participants at risk
NucleomaxX 36 grams TID every other day
NucleomaxX: NucleomaxX 36 grams TID every other day
|
Switch to TDF
n=24 participants at risk
Switch of AZT or d4T to tenofovir
Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir
|
|---|---|---|
|
Blood and lymphatic system disorders
Incisional hematoma Gr. 1 & 2
|
7.7%
2/26 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
20.8%
5/24 • Number of events 5 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Infected Incisional hematoma Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Incisional seroma Gr. 1 & 2
|
7.7%
2/26 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Metabolism and nutrition disorders
Hyperglycemia Gr. 1 & 2
|
11.5%
3/26 • Number of events 4 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Metabolism and nutrition disorders
Hypoglycemia Gr. 1 & 2
|
7.7%
2/26 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
8.3%
2/24 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Hypophosphatemia Gr. 2
|
15.4%
4/26 • Number of events 6 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
16.7%
4/24 • Number of events 4 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis Gr. 1
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Cardiac disorders
Tachycardia Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Vascular disorders
Thrombocytopenia Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Elevated triglycerides Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Respiratory, thoracic and mediastinal disorders
URI Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Elevated AST Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
8.3%
2/24 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Gastrointestinal disorders
Diarhhea
|
7.7%
2/26 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Blood and lymphatic system disorders
Neurtropenia Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Ear and labyrinth disorders
Otitis Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Prob. Herpes simplex Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Renal and urinary disorders
Prob. Renal calculus Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Gastrointestinal disorders
Rash/Bactrim allergy Gr. 1
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Elevated CK Gr. 2
|
7.7%
2/26 • Number of events 3 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Vascular disorders
Abnormal LDL Chol Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Herpes zoster Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Incisional neuritis Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Blood and lymphatic system disorders
Gross hematuria Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Vascular disorders
Abnormal cholesterol Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Metabolism and nutrition disorders
Abnormal Glucose Gr. 1 & 2
|
7.7%
2/26 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
8.3%
2/24 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Abnormal ALT Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Abnormal BMD/T score Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Abnormal creatine Gr. 2
|
7.7%
2/26 • Number of events 2 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Abnormal FBS Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
General disorders
Elevated LFTs Gr. 2
|
0.00%
0/26 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
4.2%
1/24 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
|
Eye disorders
Chalazion left eye - Gr. 2
|
3.8%
1/26 • Number of events 1 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
0.00%
0/24 • Weeks 4,8,12,18 and 36
Study evaluation was conducted at study entry and week 48; and additional safety visits were carried out at weeks 4,8,12,18 and 36 for the purpose of clinical and laboratory monitoring for toxicities, intolerance and adherance.
|
Additional Information
Dr. Grace McComsey
University Hospitals Case Medical Center
Phone: 216-844-2739
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place