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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:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
HIV Osteopenia Osteoporosis HIV Infections Drug: Raltegravir Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Study Start Date : October 2009
Primary Completion Date : June 2012
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Raltegravir Drug: Raltegravir
Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
Other Names:
  • Isentress
  • MK-0518


Outcome Measures

Primary Outcome Measures :
  1. Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips [ Time Frame: from Baseline to Weeks 48 and 96 ]
    Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96


Secondary Outcome Measures :
  1. Percentage of Participants With HIV Viral Load <50 Copies/mL [ Time Frame: from Baseline to Week 96 ]
    Plasma HIV viral load remained <50 copies/mL


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939874


Locations
Australia, New South Wales
East Sydney Doctors
Sydney, New South Wales, Australia, 2010
Holdsworth Medical Practice
Sydney, New South Wales, Australia, 2010
St Vincents Hospital
Sydney, New South Wales, Australia, 2010
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
St Vincent's Hospital, Sydney
Merck Sharp & Dohme Corp.
Holdsworth House Medical Practice
The Alfred
Investigators
Principal Investigator: Andrew D Carr, Professor St Vincents Hospital
More Information

Responsible Party: Andrew Carr, Professor, Head Clinical Research program, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT00939874     History of Changes
Other Study ID Numbers: TROP
First Posted: July 15, 2009    Key Record Dates
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015
Last Verified: May 2015

Keywords provided by Andrew Carr, St Vincent's Hospital, Sydney:
HIV+
Raltegravir
Tenofovir
osteopenia
osteoporosis
bone markers
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Osteoporosis
Bone Diseases, Metabolic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Tenofovir
Raltegravir Potassium
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors