HIV MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10020180 Term: HIV positive System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10020188 Term: HIV test positive System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ C
Conditions
Interventions
Trade Name: Prezista
Pharmaceutical Form: Tablet
INN or Proposed INN: Darunavir
CAS Number: 206361-99-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Trade
Sponsors
Guy's & St. Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and Females aged between 18 and 65 2. Documented Positive HIV 1-antibody test 3. Plasma HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • Pregnant or breast feeding • Patient unlikely to comply with protocol, and in particular adhere to therapeutic regimen • Hep B sAg positive at screening or prior to starting antiretroviral therapy (ARV) • Known active HCV • Documented hepatic impairment • Major protease inhibitor mutations likely to significantly impact on the efficacy of darunavir/ritonavirDocumented osteoporosis requiring treatment • Diabetes mellitus • Received vitamin D supplementation within 3 months of screening visit. • Women of childbearing potential, or sexually active males with female partners of childbearing potential unwilling to use barrier method contraception (condoms) • Hypersensitivity to any of the active substances and excipients • Current or likely use of any of the following substances would exclude an individual from the trial: rifampicin, antiarrhythmics (amiodarone, bepridil, encainide, flecanide, propafenone, quinidine, systemic lidocaine), alfuzosin, analgesics (Pethidine, piroxicam, propoxyphne),antihistamines (astemizole, terfenadine), Antibiotics (fusidic acid), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), antipsychotics/neuroleptics (Clozapine, pimozide, sertindole), sedatives/hypnotics (Clorazepate, diazepam, estazolam, flurazepam, triazolam and midazolam administered orally) and HMG-CoA reductase inhibitors (simvastatin and lovastatin), PDE5 inhibitor (Sildenafil), St. John’s Wort and/or any CYP3A inhibitors. • Individuals experiencing side effects from their current regime will not be excluded from analysis. • Documented HIV-2 antibody test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This project aims to assess the potential long-term advantages of switching HIV patients from the standard therapy (Atripla) to a different regime of treatment (darunavir 800 mg / ritonavir 100 mg). This will be assessed by measuring Vitamin D levels, calcium and phosphate homeostasis (balance), kidney (tubular) function, bone turnover and bone mineralisation, and HIV disease progression in all the patients who take part in the study. ;Secondary Objective: This study hopes to show that patients who are switched to darunavir/ritonavir treatment have a benefit over the patients who stay on the standard Atriplar therapy in the following areas: • Reduction in parathyroid hormone levels • Improvements in serum calcium, phosphate, alkaline phosphatase • Improvement in estimated glomerular filtration rate, albuminuria and proteinuria, tubular phosphate reabsorption and other markers of renal tubular dysfunction • Improvement in bone mineral density • Immune activation: change in immune activation (CD8+CD38+) • The proportion of participants with two consecutive HIV-RNA values > 50 copies/ml. ;Primary end point(s): Change in 25(OH)Vitamin D;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes from baseline in immune activation (CD8+CD38+ expression),parathyroid hormone, alkaline phosphatase (ALP), calcium (corrected for albumin), phosphate (fasting), tubular proteinuria (retinal-binding protein/creatinine ratio), renal tubular phosphate reabsorption (TmPO4/GFR) at 12, 24 and 48 weeks, and bone mineral density (DEXA) at 48 weeks;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
United Kingdom
Contacts
Public ContactDr Alastair Teague
Guy’s & St. Thomas’ NHS Foundation Trust
Outcome results
None listed