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: April 15, 2014
Last verified: April 2014
  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 BMD will improve in osteopenic or osteoporotic patients switching from ART including 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: Allocation: Non-Randomized
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:
  • BMD of lumbar spine and hips [ Time Frame: over 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LFTS, urea, electrolytes, creatinine, VL and CD4 count, Bone alkaline phosphatase and osteocalcin, N-telopeptide [ Time Frame: at 48 & 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 37
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 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-OH 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 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
St Vincents Hospital
Sydney, New South Wales, Australia, 2010
Holdsworth Medical Practice
Sydney, New South Wales, Australia, 2010
East Sydney Doctors
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
Last Updated: April 15, 2014
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Osteoporosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Tenofovir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 19, 2014