Trial Outcomes & Findings for Switch From Tenofovir to Raltegravir for Low Bone Mineral Density (NCT NCT00939874)

NCT ID: NCT00939874

Last Updated: 2015-06-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: from Baseline to Weeks 48 and 96
• Results posted on: 2015-06-12

Participant Flow

Participant milestones

Measure	Raltegravir Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Overall Study STARTED	52
Overall Study Completed Week 48	37
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Baseline characteristics by cohort

Measure	Raltegravir n=37 Participants Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment Australia	37 participants n=5 Participants

PRIMARY outcome

Timeframe: from Baseline to Weeks 48 and 96

Population: 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.

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

Outcome measures

Measure	Raltegravir n=37 Participants Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips Spine BMD, week 48 (n=37)	2.7 percent change Interval 1.6 to 3.7
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips Spine BMD, week 96 (n=32)	3.0 percent change Interval 1.8 to 4.1
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips Total hip BMD week 48 (n=37)	2.3 percent change Interval 1.4 to 3.1
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips Total hip BMD week 96 (n=32)	1.9 percent change Interval 1.1 to 2.5

SECONDARY outcome

Timeframe: from Baseline to Week 96

Population: Week 96 data were available for 32 completed participants

Plasma HIV viral load remained <50 copies/mL

Outcome measures

Measure	Raltegravir n=32 Participants Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Percentage of Participants With HIV Viral Load <50 Copies/mL	90.6 percentage of participants

Adverse Events

Raltegravir

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Raltegravir n=37 participants at risk Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Pregnancy, puerperium and perinatal conditions PARTNER PREGNANCY	2.7% 1/37 • Number of events 1 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Musculoskeletal and connective tissue disorders RIGHT FLANK/QUADRANT PAIN	2.7% 1/37 • Number of events 1 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Blood and lymphatic system disorders CEREBRAL ANEURYSM	2.7% 1/37 • Number of events 1 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Renal and urinary disorders LEFT KIDNEY STONES	2.7% 1/37 • Number of events 1 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Musculoskeletal and connective tissue disorders PROBABLE LUMBAR RADICULOPATHY	2.7% 1/37 • Number of events 1 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Gastrointestinal disorders HOSPITAL ADMISSION FOR MALENA AND FEVERS	2.7% 1/37 • Number of events 1 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders LOWER REPIRATORY TRACT INFECTION	2.7% 1/37 • Number of events 1 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Other adverse events

Measure	Raltegravir n=37 participants at risk Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
Gastrointestinal disorders Abdominal Cramps	5.4% 2/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Cold	5.4% 2/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Eye disorders Conjunctivitis	5.4% 2/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Gastrointestinal disorders Diarrhoea	10.8% 4/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Gastrointestinal disorders Reflux	5.4% 2/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea	5.4% 2/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	18.9% 7/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Respiratory, thoracic and mediastinal disorders Viral Upper Respiratory Tract Infection	5.4% 2/37 • at 48 and 96 weeks An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Additional Information

Professor Andrew Carr

St Vincents Hospital

Phone: +61 2 8382 3359

Email: andrew.carr@svha.org.au

Results disclosure agreements

• Principal investigator is a sponsor employee The Institution, its personnel and the Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the sponsor. This includes periodic information releases and announcements to the news media or a third party regarding the progress of this Study.
• Publication restrictions are in place

Restriction type: OTHER