Human immunodeficiency virus (HIV) infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Fostolin
Product Name: Fostolin (alendronate)
Pharmaceutical Form: Tablet
INN or Proposed INN: ALENDRONATE SODIUM
CAS Number: 121268-17-5
Other descriptive name: Fostolin
Concentration uni
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male>25 years old or female>30 years old - HIV-1 antibody positive (no CD4 or HIV RNA criteria) - antiretroviral therapy naïve* (not having had suppressive ART in the prior 12 months) - be presumed to have achieved peak bone mass - eligible for initiation of antiretroviral therapy in the opinion of the investigator - able to provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Subjects unable to comply with the study protocol or unable to stand/sit upright for at least 30 minutes - history of osteoporosis (defined as hip, femoral neck or spine T score of 50 or in post-menopausal women) - history of fragility fracture or previous femoral fracture - chronic renal failure estimated by eGFR2.6mmol/L) at screening - history of Paget’s disease or known primary hyperparathyroidism - previous treatment with or allergy (including hypersensitivity) to bisphosphonates - recent history (past 12 months) of peptic or duodenal ulcers or oesophagitis, aspiration or any other upper gastro-intestinal problem or oesophageal disease that in the opinion of the investigator precludes the use of alendronate - history of dental disease, periodontal disease, poor oral hygiene (as judged in the opinion of the investigator) or recent invasive dental procedures (within the past 3 months) comprising dental extraction and dental prosthetic - current therapy with prescribed calcium or vitamin D preparations (other than over-the-counter multivitamin preparations) - current therapy with aspirin or other regularly prescribed non-steroidal anti-inflammatory drugs - recent significant steroid exposure defined as continual or cumulative use of >5mg prednisolone daily or equivalent for = three months, as per EACS guidelines - for female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study - where in the investigator’s opinion, there is a necessity to initiate ART within the pre-ART study window period (i.e. within the period between screening and ART initiation (approximately 3 weeks) - subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection - any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study - cancer or receiving chemotherapy or radiotherapy - subjects concurrently enrolled in another clinical trial of an investigational medical product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In antiretroviral-naïve, HIV1-infected adults, to compare the effect of a short (14 week) course of oral alendronate 70mg weekly versus placebo combined with calcium and vitamin D, initiated 2 weeks prior to start of antiretroviral therapy (ART) for HIV1 infection on ART-induced bone mineral density (BMD) loss over 48 weeks of follow-up post ART initiation. ;Secondary Objective: To explore the effect of alendronate on bone turnover in HIV-1 infected subjects initiating ART. To determine which factors, such as choice of ART, impacts the protective effect of alendronate in preventing BMD loss. To investigate relationships between ART-induced changes in immune function, inflammation, bone metabolism and BMD. ;Primary end point(s): Between-group difference in percentage change in total hip BMD from baseline to week 50 among subjects who received at least one dose of study medication.;Timepoint(s) of evaluation of this end point: Baseline and week 50 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Between-group differences in percentage change in lumbar spine, femoral neck BMD and body composition to week 50. Between-group differences in percentage change in total hip, lumbar spine and femoral neck BMD to weeks 14 and 26. Between-group differences in percentage change in bone turnover markers to weeks 26 and 50. Between-group differences in percentage change in 25(OH)D, PTH and calcium to week 50. Between-group differences in ART-induced changes immune function, BMD and bone turnover to week 14 and 50. Between-group differences in measures of safety. ;Timepoint(s) of evaluation of this end point: Baseline, week 14, week 26 and week 50 | — |
Countries
Denmark, Ireland
Contacts
Public ContactHIV Molecular Research Group
University College Dublin
Outcome results
None listed