HIV-infected patients with low bone mineral density MedDRA version: 16.0 Level: LLT Classification code 10020175 Term: HIV infection with other conditions System Organ Class: 100000004862
Conditions
Interventions
Product Name: Dolutegravir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dolutegravir
Other descriptive name: DOLUTEGRAVIR
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patient (>18 years old) having a diagnosis of HIV-1 infection. 2. Current HAART including abacavir plus lamivudine (kivexa) plus a boosted PI, started at least 6 months before. 3. Maintained undetectable plasma HIV-1 RNA (VL =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Suspected or documented resistance mutations to integrase inhibitors or nucleoside reverse transcriptase inhibitors. 2. Secondary osteoporosis/osteopenia (testosterone deficit, thyroid disease, ?), except vitamin D deficit. 3. Therapy with biphosphonates within the last 6 months. 4. Have used integrase inhibitors 5. Pregnant or breastfeeding. 6. Subjects with Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN), OR ALT = 3xULN and bilirubin = 1.5xULN (with >35% direct bilirubin) 7. Subjects with severe hepatic impairment (Class B or C) as determined by Child-Pugh classification 8. Patients infected with hepatitis B virus (HBV) who can not use entecavir or telbividina. 9. Patients infected with hepatitis C virus (HCV) in which is expected to begin treatment during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate changes in BMD 48 weeks after the switch from a PI to dolutegravir in HIV-infected patients with low bone mineral density.; Secondary Objective: To evaluate the changes in bone turn-over markers To evaluate the antiviral efficacy of the switch. To evaluate the tolerability and safety of the switch. ; Primary end point(s): ? Compare changes in BMD measured by DEXA at week 48 from baseline. ? Compare changes in T-score measured by DEXA at week 48 from baseline. ? Compare percentages of patients who improve from osteoporosis to osteopenia or from osteopenia to normal BMD throughout the 48 weeks of the study, considering the WHO criteria. ;Timepoint(s) of evaluation of this end point: At week 48 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Compare changes in bone turn-over (osteocalcine, specific alcaline phosphatasa, N-telopeptide) at week 48 from baseline. ? Compare percentages of patients who experienced virological failure throughout the 48 weeks of the study. Virological failure will be defined as an increase in HIV RNA >50 copies in 2 determinations within 1 month. ? Compare changes in CD4+/CD8+ T lymphocytes at week 48 from baseline. ? Determination of antiretroviral resistance at the time of virological failure and comparison with baseline. ? Compare changes in lipid parameters (total, HDL-, LDL-cholesterol and triglyceride levels) at week 48 relative to baseline values. ? Compare changes in renal parameters (filtrate glomerular rate by MDRD equation, cratinine, albumine/creatinine and proteinuria/cratinine ratios) at week 48 relative to baseline values. ? Compare percentages of patients who withdraw from the study. ? Compare percentages of patients who withdraw from the study due to toxicity. ? Compare percentages of patients with toxicity ? grade 3. ;Timepoint(s) of evaluation of this end point: At week 48 from baseline | — |
Countries
Spain
Contacts
Public ContactClinical Research Associates
Fundació Lluita contra la SIDA
Outcome results
None listed