Switch From Tenofovir to Raltegravir for Low Bone Mineral Density - Full Text View

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

This study is not yet open for participant recruitment.

Verified by St Vincent's Hospital, Sydney, July 2009

First Received: July 14, 2009 Last Updated: August 14, 2009 History of Changes

Sponsor:	St Vincent's Hospital, Sydney
Collaborators:	Merck Holdsworth House Medical Practice The Alfred Hospital, Melbourne
Information provided by:	St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:	NCT00939874

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Resource links provided by NLM:

MedlinePlus related topics: AIDS Minerals Osteoporosis

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Raltegravir

U.S. FDA Resources

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

Primary Outcome Measures:

Bone Mineral Density [ Time Frame: over 48 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: over 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	September 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Raltegravir: Active Comparator	Drug: Raltegravir Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

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 hip 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, untreated hypothyroidism or hyperparathyroidism according to local reference ranges)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939874

Contacts

Contact: Robyn A Richardson, RN	+61 2 8382 3872	rrichardson1@stvincents.com.au
Contact: Andrew D Carr, Professor	+61 2 8382 3438	acarr@stvincents.com.au

Locations

Australia, New South Wales
St Vincents Hospital
Sydney, New South Wales, Australia, 2010
Holdsworth Medical Practice
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 Hospital, Melbourne

Investigators

Principal Investigator:

Andrew D Carr, Professor

St Vincents Hospital

More Information

No publications provided

Responsible Party:	St Vincents Hospital, Sydney ( Professor Andrew Carr )
Study ID Numbers:	TROP
Study First Received:	July 14, 2009
Last Updated:	August 14, 2009
ClinicalTrials.gov Identifier:	NCT00939874 History of Changes
Health Authority:	Australia:St Vincents Hospital Research Ethics Office

Keywords provided by St Vincent's Hospital, Sydney:

HIV+
Raltegravir
Tenofovir
osteopenia

osteoporosis
bone markers
treatment experienced

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Bone Diseases
Reverse Transcriptase Inhibitors
Musculoskeletal Diseases
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Osteoporosis
Bone Diseases, Metabolic
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on February 08, 2010