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 ongoing, but not recruiting participants.

First Received on July 14, 2009. Last Updated on October 12, 2011 History of Changes

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

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:	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

MedlinePlus related topics: Bone Density HIV/AIDS Minerals Osteoporosis

Drug Information available for: Tenofovir Tenofovir disoproxil 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: Isentress MK-0518

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 February 09, 2012