NCT00939874

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_4 hiv

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 12, 2015

Completed
Last Updated

June 12, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

July 14, 2009

Results QC Date

January 13, 2015

Last Update Submit

May 28, 2015

Conditions

HIVOsteopeniaOsteoporosisHIV Infections

Keywords

HIV+RaltegravirTenofovirosteopeniaosteoporosisbone markerstreatment experienced

Outcome Measures

Primary Outcomes (1)

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

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

    from Baseline to Weeks 48 and 96

Secondary Outcomes (1)

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

    from Baseline to Week 96

Study Arms (1)

Raltegravir

EXPERIMENTAL
Drug: Raltegravir

Interventions

RaltegravirDRUG

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

Also known as: Isentress, MK-0518
Raltegravir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

East Sydney Doctors

Sydney, New South Wales, 2010, Australia

Location

Holdsworth Medical Practice

Sydney, New South Wales, 2010, Australia

Location

St Vincents Hospital

Sydney, New South Wales, 2010, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosisHIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Professor Andrew Carr
Organization
St Vincents Hospital
andrew.carr@svha.org.au
+61 2 8382 3359

Study Officials

  • Andrew D Carr, Professor

    St Vincents Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head Clinical Research program

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

April 1, 2014

Last Updated

June 12, 2015

Results First Posted

June 12, 2015

Record last verified: 2015-05

Locations

AU(4)