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Switch From Tenofovir to Raltegravir for Low Bone Mineral Density (TROP)

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ClinicalTrials.gov Identifier: NCT00939874
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Holdsworth House Medical Practice
The Alfred
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital, Sydney

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
Osteopenia
Osteoporosis
HIV Infections
Intervention Drug: Raltegravir
Enrollment 52

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raltegravir
Hide Arm/Group Description Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Period Title: Overall Study
Started 52
Completed Week 48 37
Completed 32
Not Completed 20
Arm/Group Title Raltegravir
Hide Arm/Group Description Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
35
  94.6%
>=65 years
2
   5.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
50
(30 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
1
   2.7%
Male
36
  97.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 37 participants
37
1.Primary Outcome
Title Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
Hide Description Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96
Time Frame from Baseline to Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Week 48 data were available for 37 completed participants and Week 96 data were available for 32 completed participants. Fifteen of the enrolled 52 participants were screen failures.
Arm/Group Title Raltegravir
Hide Arm/Group Description:
Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Overall Number of Participants Analyzed 37
Mean (95% Confidence Interval)
Unit of Measure: percent change
Spine BMD, week 48 (n=37)
2.7
(1.6 to 3.7)
Spine BMD, week 96 (n=32)
3.0
(1.8 to 4.1)
Total hip BMD week 48 (n=37)
2.3
(1.4 to 3.1)
Total hip BMD week 96 (n=32)
1.9
(1.1 to 2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Raltegravir
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HIV Viral Load <50 Copies/mL
Hide Description Plasma HIV viral load remained <50 copies/mL
Time Frame from Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Week 96 data were available for 32 completed participants
Arm/Group Title Raltegravir
Hide Arm/Group Description:
Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
90.6
Time Frame at 48 and 96 weeks
Adverse Event Reporting Description An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
 
Arm/Group Title Raltegravir
Hide Arm/Group Description Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
All-Cause Mortality
Raltegravir
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir
Affected / at Risk (%) # Events
Total   5/37 (13.51%)    
Blood and lymphatic system disorders   
CEREBRAL ANEURYSM   1/37 (2.70%)  1
Gastrointestinal disorders   
HOSPITAL ADMISSION FOR MALENA AND FEVERS   1/37 (2.70%)  1
Musculoskeletal and connective tissue disorders   
RIGHT FLANK/QUADRANT PAIN   1/37 (2.70%)  1
PROBABLE LUMBAR RADICULOPATHY   1/37 (2.70%)  1
Pregnancy, puerperium and perinatal conditions   
PARTNER PREGNANCY   1/37 (2.70%)  1
Renal and urinary disorders   
LEFT KIDNEY STONES   1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders   
LOWER REPIRATORY TRACT INFECTION   1/37 (2.70%)  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%
Raltegravir
Affected / at Risk (%) # Events
Total   23/37 (62.16%)    
Eye disorders   
Conjunctivitis   2/37 (5.41%) 
Gastrointestinal disorders   
Abdominal Cramps   2/37 (5.41%) 
Diarrhoea  1  4/37 (10.81%) 
Reflux   2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders   
Cold   2/37 (5.41%) 
Sleep Apnoea   2/37 (5.41%) 
Upper Respiratory Tract Infection   7/37 (18.92%) 
Viral Upper Respiratory Tract Infection   2/37 (5.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 4
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.
The Institution, its personnel and the Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the sponsor. This includes periodic information releases and announcements to the news media or a third party regarding the progress of this Study.
Results Point of Contact
Name/Title: Professor Andrew Carr
Organization: St Vincents Hospital
Phone: +61 2 8382 3359
Responsible Party: Andrew Carr, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT00939874     History of Changes
Other Study ID Numbers: TROP
First Submitted: July 14, 2009
First Posted: July 15, 2009
Results First Submitted: January 13, 2015
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015