Bone Health in Aging HIV Infected Women

What this trial studies

Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for \> 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks.

Conditions in scope

• Osteoporosis
• HIV
• Menopause

Interventions

• tenofovir-alafenamide-emtricitabine (Drug) — comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
• tenofovir-emtricitabine (Drug) — comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density

Who can join

Women only · Ages 40 Years to 60 Years

Inclusion criteria

• Biological female aged 40-60
• Documented HIV-1 infection
• Peri-menopausal ( as documented by history).
• Signed Informed Consent Form and willing to comply with the protocol.
• Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir or raltegravir or elvitegravir) in combination with TDF-FTC for \> 24 weeks.
• Stable viral suppression (plasma HIV-RNA\<50 copies/mL for \> 24 weeks). Single viral blip \<500/ml allowed if re-suppresses.
• If of childbearing potential, is using effective birth control methods and is willing to continue during the trial.
• Women will be assessed for vitamin D and calcium dietary intake; if inadequate for age, supplements will be recommended.

Exclusion criteria

• HIV-2
• High 10-year fracture risk at baseline ( \> 20%) based on country specific FRAX
• Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, strontium
• Current use of systemic steroids ( inhaled steroids permitted) or chemotherapeutic agents
• Acute viral hepatitis
• Chronic hepatitis C with liver transaminases \>5 x ULN or expected to require treatment for hepatitis C during the trial period.
• Any investigational ARV within 30 days.
• Dialysis or renal insufficiency (creatinine clearance \< 50ml/min)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2017-09-12
• Primary completion: 2021-02-25
• Last update posted: 2024-12-19
• First posted: 2016-06-28

Sponsor & contact

Lead sponsor: University Health Network, Toronto (Other)

Collaborators: University of Modena and Reggio Emilia, San Raffaele University Hospital, Italy, Gilead Sciences, CIHR Canadian HIV Trials Network

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine (Baseline, 48 weeks and 96 weeks)
  The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic.

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