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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Holdsworth House Medical Practice
The Alfred
Information provided by (Responsible Party):
Andrew Carr, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:
NCT00939874
First received: July 14, 2009
Last updated: May 28, 2015
Last verified: May 2015
  Purpose

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 Intervention Phase
HIV
Osteopenia
Osteoporosis
HIV Infections
Drug: Raltegravir
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by St Vincent's Hospital, Sydney:

Primary Outcome Measures:
  • Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips [ Time Frame: from Baseline to Weeks 48 and 96 ] [ Designated as safety issue: No ]
    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 [ Time Frame: from Baseline to Week 96 ] [ Designated as safety issue: Yes ]
    Plasma HIV viral load remained <50 copies/mL


Enrollment: 52
Study Start Date: October 2009
Study Completion Date: April 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir Drug: Raltegravir
Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
Other Names:
  • Isentress
  • MK-0518

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 14, 2009
Results First Received: January 13, 2015
Last Updated: May 28, 2015
Health Authority: Australia: Therapeutic Goods Administration (TGA)

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Tenofovir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015