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.

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Key information

Conditions

HIV Blood-Borne Infections Bone Diseases Bone Diseases, Metabolic Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

East Sydney Doctors, Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 dual energy x-ray absorptiometry (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-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

Treatment and study plan

raltegravir

Drug

Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

Other names: Isentress, MK-0518

Primary outcomes

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips

Time frame: from Baseline to Weeks 48 and 96

Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96

Secondary outcomes

Percentage of Participants With HIV Viral Load <50 Copies/mL

Time frame: from Baseline to Week 96

Plasma HIV viral load remained <50 copies/mL

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital, Sydney

Other

Collaborators

Holdsworth House Medical Practice
Merck Sharp & Dohme LLC
The Alfred

Registry information

Acronym: TROP

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2014
First posted: Jul 15, 2009
Registry last updated: Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed