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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00939874




Registration number
NCT00939874
Ethics application status
Date submitted
14/07/2009
Date registered
14/07/2009
Date last updated
28/05/2015

Titles & IDs
Public title
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Scientific title
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Secondary ID [1] 0 0
TROP
Universal Trial Number (UTN)
Trial acronym
TROP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Osteopenia 0 0
Osteoporosis 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Raltegravir

Experimental: Raltegravir -


Treatment: Drugs: Raltegravir
Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips - Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96
Timepoint [1] 0 0
from Baseline to Weeks 48 and 96
Secondary outcome [1] 0 0
Percentage of Participants With HIV Viral Load <50 Copies/mL - Plasma HIV viral load remained <50 copies/mL
Timepoint [1] 0 0
from Baseline to Week 96

Eligibility
Key inclusion criteria
1. provision of written, informed consent

2. HIV-infected adults at least 18 years of age

3. receiving stable ART including TDF and a r/PI for the previous 6 months

4. no prior PI genotypic resistance or known replication of HIV in patients receiving a
PI

5. plasma HIV RNA < 50 copies/ml for at least the previous 3 months

6. spine or neck of femur t-score = -1.0 (i.e. WHO-defined osteopenia) measured by dual
energy x-ray absorptiometry (DEXA)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
7. participation in any other clinical trial (unless approved by the study PI)

8. use of TDF for previously active chronic hepatitis B infection

9. receiving or requiring therapy for low BMD (including prior fragility fracture)

10. using oral corticosteroids or inhaled fluticasone

11. virological failure on, or intolerance to, RAL

12. contra-indication to RAL therapy (see appendix 2)

13. breast-feeding

14. pregnancy

15. secondary, endocrinological cause of low BMD:25-hydroxy vitamin D deficiency,
hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone > 25% below
lower limit of reference range and/or luteinizing hormone > 2 x upper limit of normal
(ULN),untreated hypothyroidism or hyperparathyroidism according to local reference
ranges

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
East Sydney Doctors - Sydney
Recruitment hospital [2] 0 0
Holdsworth Medical Practice - Sydney
Recruitment hospital [3] 0 0
St Vincents Hospital - Sydney
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Holdsworth House Medical Practice
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Alfred
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if low bone mineral density (a measurement of how
thick and strong bones are) improves in adults with HIV infection who switch their HIV
medication tenofovir to another HIV medication raltegravir.

Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic
patients switching from ART including tenofovir disoproxil fumarate (TDF) and a
ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.
Trial website
https://clinicaltrials.gov/show/NCT00939874
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew D Carr, Professor
Address 0 0
St Vincents Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications