Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people, all of whom received a HIV medication called raltegravir. The trial was measuring changes in bone mineral density (a measure of how dense and strong bones are) in the lower spine and hips over time, as well as whether participants' HIV remained at very low levels in the blood. By the end of the study, 32 people had fully completed it, while 20 did not finish for various reasons. The reported data shows that bone mineral density in the lower spine increased by an average of 2.7% at week 48 and 3.0% at week 96. In the hips, the reported figures were an average increase of 2.3% at week 48 and 1.9% at week 96. These are percentage changes from where each participant started at the beginning of the trial. For the secondary outcome, the reported data shows that 90.6% of participants had HIV levels in the blood below 50 copies per millilitre — a threshold commonly used to indicate very low, hard-to-detect levels of the virus. It is worth noting that the trial involved only one group (everyone received raltegravir), so there was no comparison group reported in this data. Some outcome details, such as individual timepoint breakdowns for the hip measurements, were not fully separated in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Osteoporosis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are willing and able to give written consent to participate
- You are an adult aged 18 or older who is living with HIV
- You have been on a stable HIV treatment regimen that includes two specific medications (tenofovir/TDF and a type of drug called a boosted protease inhibitor) for at least the past 6 months
- You have no history of your HIV becoming resistant to a type of HIV drug called a protease inhibitor
- Your HIV levels in the blood have been undetectable (very low) for at least the past 3 months
- A bone density scan (a special type of X-ray) has shown that you have lower than normal bone density in your spine or hip (a condition sometimes called osteopenia)
Who may not be able to join:
- You are currently taking part in another clinical trial (unless the lead researcher gives special approval)
- You are taking tenofovir (TDF) specifically to treat a chronic hepatitis B infection
- You are currently receiving, or need to receive, treatment for low bone density — including if you have previously had a fragility fracture (a broken bone caused by weak bones)
- You are currently taking steroid tablets by mouth, or using an inhaled steroid medication called fluticasone
- Your HIV treatment has previously stopped working with, or you have had a bad reaction to, a drug called raltegravir (RAL)
- You have a medical reason why you cannot take raltegravir (confirm with trial site)
- You are currently breastfeeding
- You are pregnant
- You have a medical condition affecting your hormones or body chemistry that is causing your low bone density — such as low vitamin D levels, low hormone levels (including low testosterone or imbalanced hormones), an underactive thyroid, or overactive parathyroid glands (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Andrew D Carr, Professor, St Vincents Hospital
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.