Human Immunodeficiency Virus MedDRA version: 18.1 Level: LLT Classification code 10020434 Term: Human immunodeficiency virus infection causing other specified conditions System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Triumeq
Pharmaceutical Form: Film-coated tablet
Product Name: Tenofovir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tenofovir
Other descriptive name: TENOFOVIR DISOPROXIL
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Documented HIV-1 antibody test • Female aged >40 years • Plasma HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: • Hepatitis B surface antigen positive (at any time since HIV diagnosis) • Hepatitis C co-infection (HCV IgG negative, if HCV IgG positive must be HCV RNA negative) • Known HIV resistance mutations to any of the study drugs • Current or planned use of bisphosphonates • Screening laboratory parameters =/> grade 3 (ACTG criteria – see appendix A) • Creatinine clearance 3 units daily for the past month) or drug dependence which would make the participant unable to comply with the protocol (investigator opinion) • Active opportunistic infection within the last 4 weeks • Significant co-morbidities (investigator opinion) • Untreated hyperthyroidism (TSH below the lower limit of the normal range) • Female patients of child-bearing potential who have/are: o positive pregnancy test at screening or during the study o breast feeding o planning to become pregnant o unwilling to use adequate contraception throughout the study • Individuals unable or unwilling to comply with the requirements of the study (investigator opinion). • Hypersensitivity to any of the active substances or excipients • Current or likely use of any of the following substances: o Carbamazepine, Oxcarbazine, Phenobarbitone, Phenytoin, St John’s Wort, dofetilide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to compare the changes in bone mineral density (BMD) over 96 weeks in women who switch from Truvada/NNRTI to Triumeq, as compared to women who stay on their current Truvada/NNRTI regimen.;Secondary Objective: Tenofovir (a component of truvada, atripla and eviplera) has been associated with hyperparathyroidism, increased bone turnover and kidney injury. Secondary outcomes will examine parathyroid hormone concentrations, bone turnover markers and kidney function. ;Primary end point(s): Changes in total hip BMD at week 48 between the 2 study treatment arms (women continuing on Truvada/NNRTI vs. those switching to Triumeq) ;Timepoint(s) of evaluation of this end point: The primary endpoint will be analysed at 48 weeks from randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in spine, total hip and neck of femur BMD at 24, 48 and 96 weeks • Changes in parathyroid hormone at 24, 48 and 96 weeks • Changes in bone turnover markers at 24, 48 and 96 weeks • Changes in renal function at 4, 12, 24, 48 and 96 weeks • Changes in urinary albumin, protein, retinol-binding protein excretion and fractional excretion of phosphate at 24, 48 and 96 weeks ;Timepoint(s) of evaluation of this end point: The timepoints will include 24, 48 and 96 weeks. | — |
Countries
United Kingdom
Contacts
Public ContactDr Frank Post
King's College Hospital NHS Foundation Trust
Outcome results
None listed