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

July 14, 2009
May 28, 2015
October 2009
June 2012   (final data collection date for primary outcome measure)
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
Bone Mineral Density [ Time Frame: over 48 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00939874 on ClinicalTrials.gov Archive Site
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
LFTS, urea, electrolytes, creatinine, VL and CD4 count, Bone alkaline phosphatase and osteocalcin, N-telopeptide [ Time Frame: over 48 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Osteopenia
  • Osteoporosis
  • HIV Infections
Drug: Raltegravir
Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
Other Names:
  • Isentress
  • MK-0518
Experimental: Raltegravir
Intervention: Drug: Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2014
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00939874
TROP
Yes
Andrew Carr, St Vincent's Hospital, Sydney
St Vincent's Hospital, Sydney
  • Merck Sharp & Dohme Corp.
  • Holdsworth House Medical Practice
  • The Alfred
Principal Investigator: Andrew D Carr, Professor St Vincents Hospital
St Vincent's Hospital, Sydney
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP