HIVPhase 4TROPNCT00939874

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

A Phase 4 study testing Raltegravir in people with HIV and Osteopenia, run by St Vincent's Hospital, Sydney at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, Osteopenia, Osteoporosis
What is being tested?: Raltegravir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 4 sitesAustralia
Study dates: Oct 2009to Apr 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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)

Show all 9Show fewer

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

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

The Alfred Hospital
Melbourne, Victoria, 3004
East Sydney Doctors
Sydney, New South Wales, 2010
Holdsworth Medical Practice
Sydney, New South Wales, 2010
St Vincents Hospital
Sydney, New South Wales, 2010

Other trials in Australia

About this study

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.

Conditions: HIV, Osteopenia, Osteoporosis, HIV Infections
Being tested: Raltegravir
Keywords: HIV+, Raltegravir, Tenofovir, osteopenia, osteoporosis, bone markers, treatment experienced
Medical subject headings: Bone Diseases, Metabolic, Osteoporosis, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RaltegravirDrug
Also called Isentress, MK-0518
Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

Study groups in NCT00939874
Study group	Role	What they receive
Raltegravir	Experimental	Not described Receives: Drug: Raltegravir

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: from Baseline to Weeks 48 and 96

Secondary outcomes (1)

Percentage of Participants With HIV Viral Load <50 Copies/mL
Plasma HIV viral load remained <50 copies/mL
Measured: from Baseline to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Apr 2014

First posted15 Jul 2009 (estimated)
Study startOct 2009
Primary completionJun 2012
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00939874
Sponsor's protocol ID: TROP
Acronym: TROP
Status last verified: May 2015
First submitted: 14 Jul 2009
Last updated: 12 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
ClinicalTrials.gov ID: NCT00939874
Acronym / sponsor ID: TROP / TROP
Conditions: HIV, Osteopenia, Osteoporosis, HIV Infections
Keywords: HIV+, Raltegravir, Tenofovir, osteopenia, osteoporosis, bone markers, treatment experienced
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: St Vincent's Hospital, SydneyUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, Holdsworth House Medical Practice, The Alfred
Study start: Oct 2009
Primary completion: Jun 2012 (actual)
Study completion: Apr 2014 (actual)
First posted: 15 Jul 2009 (estimated)
Results: Posted 12 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Raltegravir	Experimental	Drug: Raltegravir

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RaltegravirAlso: Isentress, MK-0518Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.	Drug	Raltegravir

Primary outcome

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

1 secondary outcome

Percentage of Participants With HIV Viral Load <50 Copies/mL
Time frame: from Baseline to Week 96

Results and safety

Results posted to the registry on 12 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Raltegravir	52	32

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

Time frame: from Baseline to Weeks 48 and 96. Mean (95% Confidence Interval). Unit: percent change

Measure	Raltegravir n = 37
Spine BMD, week 48 (n=37)	2.7 (1.6 to 3.7)
Spine BMD, week 96 (n=32)	3.0 (1.8 to 4.1)
Total hip BMD week 48 (n=37)	2.3 (1.4 to 3.1)
Total hip BMD week 96 (n=32)	1.9 (1.1 to 2.5)

Raltegravir: p <0.0001, t-test, 2 sided

Population analysed: Week 48 data were available for 37 completed participants and Week 96 data were available for 32 completed participants. Fifteen of the enrolled 52 participants were screen failures.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: at 48 and 96 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raltegravir	5 of 37 (13.5%)	23 of 37 (62.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew D Carr, Professor principal investigator

St Vincents Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Raltegravir in people with HIV and Osteopenia, run by St Vincent's Hospital, Sydney at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips (time frame: from Baseline to Weeks 48 and 96). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00939874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.