Switch From Tenofovir to Raltegravir for Low Bone Mineral Density (TROP)
This study is ongoing, but not recruiting participants.
Sponsor:
St Vincent's Hospital, Sydney
Collaborators:
Merck
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: October 12, 2011
Last verified: October 2011
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Tenofovir
Tenofovir Disoproxil Fumarate
Raltegravir
Raltegravir potassium
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | August 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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-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
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
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: | October 12, 2011 |
| 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 Bone Diseases, Metabolic 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 |
Musculoskeletal Diseases Tenofovir Tenofovir disoproxil 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 June 17, 2013