HIV infection and menopause MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: TRUVADA - 30 COMPRESSE RIVESTITE CON FILM IN FLACONE HDPE DA 200 MG/245 MG
Product Name: truvada
Product Code: J05AR03
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EMTRICIT
Sponsors
UNIVERSITY HEALTH NETWORK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biological female aged 45-55 2. Documented HIV-1 infection 3. Peri-menopausal or within 10 years of menopause 4. Signed Informed Consent Form and willing to comply with the protocol. 5. Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir, raltegravir or elvitegravir) in combination with TDF-FTC for > 24 weeks. i. Participants on a single tablet regimen containing TDF/FTC are able to participate as long as they meet the virologic suppression criteria. Those who are on more than 3 agents are eligible provided they meet these criteria. 6. Stable viral suppression (plasma HIV-RNA 24weeks). Single viral blip =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. HIV-2 infection 2. High 10-year fracture risk at screening ( > 20%) based on country specific FRAX 3. Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, stontrium 4. Current use of systemic steroids (inhaled steroids permitted) or chemotherapeutic agents 5. Acute viral hepatitis 6. Chronic hepatitis C with AST and/or ALT >5 x ULN or expected to require HCV treatment during the trial period. 7. Any investigational ARV within 30 days screening 8. Dialysis or renal insufficiency (creatinine clearance 35% direct bilirubin), or the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices. 10. Pregnant or breastfeeding 11. Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 amylase, CPK, or lipid elevation. 12. Any condition (including illicit drug use or alcohol abuse) or lab results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if: 1. Switching HIV+ women on TDF/FTC to TAF/FTC increases BMD at the spine at 48 weeks relative to those who continue TDF/FTC 2. To determine if any observed improvements continue or stabilize in the year after switch.;Secondary Objective: na;Primary end point(s): Comparison of the immediate vs delayed group in the % change from baseline in BMD at the lumbar spine at week 48.;Timepoint(s) of evaluation of this end point: Between baseline and week 48 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): % change from baseline in BMD at lumbar spine at 96 weeks; % change from baseline in BMD at hip at 48 weeks; % change from baseline in BMD at hip at 96 weeks; Changes in Bone architecture as determined by Trabecular bone scan (TBS) and HRpQCT; Changes in 10 year fracture risk determined by country specific FRAX calculator; % of patient with HIV-1 RNA <50 c/ml; Change from baseline in geriatric functional measures; Change from baseline in muscle quality; Change from baseline in lipid values and Framingham cardiovascular risk scores; Changes in renal tubular and glomerular function; Safety (clinical and laboratory adverse events); Changes in biomarkers of inflammation, coagulation and bone metabolism; Tolerability;Timepoint(s) of evaluation of this end point: at 96 week; at 48 week; at week 96; at week 48 and 96; at week 48 and 96; at week 48 and 96; at week 48 and 96; at week 48 and 96; at week 48 and 96; at week 48 and 96; at week 48 and 96; at week 48 and 96; at week 48 and 96 | — |
Countries
Canada, Italy
Contacts
Public ContactDipartimento di Scienze Mediche e C
Universit¿ di Modena e Reggio Emilia
Outcome results
None listed