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

Primary Purpose

HIV, Osteopenia, Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Raltegravir
Sponsored by
St Vincent's Hospital, Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV+, Raltegravir, Tenofovir, osteopenia, osteoporosis, bone markers, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

    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

Sites / Locations

  • East Sydney Doctors
  • Holdsworth Medical Practice
  • St Vincents Hospital
  • The Alfred Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raltegravir

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants With HIV Viral Load <50 Copies/mL
Plasma HIV viral load remained <50 copies/mL

Full Information

First Posted
July 14, 2009
Last Updated
May 28, 2015
Sponsor
St Vincent's Hospital, Sydney
Collaborators
Merck Sharp & Dohme LLC, Holdsworth House Medical Practice, The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT00939874
Brief Title
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Acronym
TROP
Official Title
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's Hospital, Sydney
Collaborators
Merck Sharp & Dohme LLC, Holdsworth House Medical Practice, The Alfred

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Osteopenia, Osteoporosis, HIV Infections
Keywords
HIV+, Raltegravir, Tenofovir, osteopenia, osteoporosis, bone markers, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raltegravir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Other Intervention Name(s)
Isentress, MK-0518
Intervention Description
Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
Primary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With HIV Viral Load <50 Copies/mL
Description
Plasma HIV viral load remained <50 copies/mL
Time Frame
from Baseline to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: provision of written, informed consent HIV-infected adults at least 18 years of age receiving stable ART including TDF and a r/PI for the previous 6 months no prior PI genotypic resistance or known replication of HIV in patients receiving a PI plasma HIV RNA < 50 copies/ml for at least the previous 3 months spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA) Exclusion Criteria: participation in any other clinical trial (unless approved by the study PI) use of TDF for previously active chronic hepatitis B infection receiving or requiring therapy for low BMD (including prior fragility fracture) using oral corticosteroids or inhaled fluticasone virological failure on, or intolerance to, RAL contra-indication to RAL therapy (see appendix 2) breast-feeding pregnancy 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Carr, Professor
Organizational Affiliation
St Vincents Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Sydney Doctors
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St Vincents Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

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