Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

HIV Infections Clinical Trial

— TROP  

Official title:

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939874
• Other study ID #: TROP
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2009
• Last updated: May 28, 2015
• Start date: October 2009
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: St Vincent's Hospital, Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration (TGA)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. provision of written, informed consent

2. HIV-infected adults at least 18 years of age

3. receiving stable ART including TDF and a r/PI for the previous 6 months

4. no prior PI genotypic resistance or known replication of HIV in patients receiving a PI

5. plasma HIV RNA < 50 copies/ml for at least the previous 3 months

6. spine or neck of femur t-score = -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA)

Exclusion Criteria:

7. participation in any other clinical trial (unless approved by the study PI)

8. use of TDF for previously active chronic hepatitis B infection

9. receiving or requiring therapy for low BMD (including prior fragility fracture)

10. using oral corticosteroids or inhaled fluticasone

11. virological failure on, or intolerance to, RAL

12. contra-indication to RAL therapy (see appendix 2)

13. breast-feeding

14. pregnancy

15. 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections
• Osteopenia
• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	East Sydney Doctors	Sydney	New South Wales
Australia	Holdsworth Medical Practice	Sydney	New South Wales
Australia	St Vincents Hospital	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
St Vincent's Hospital, Sydney	Holdsworth House Medical Practice, Merck Sharp & Dohme Corp., The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With HIV Viral Load <50 Copies/mL	Plasma HIV viral load remained <50 copies/mL	from Baseline to Week 96	Yes