Chronic HIV infection.
Conditions
Interventions
Pharmaceutical Form: Coated tablet
INN or Proposed INN: LAMIVUDINE
CAS Number: 134678-17-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: Norvir
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult (18 years old or more) HIV-1-infected subjects. - Hip or spine T-scores between -2.5 mesured by dual-energy X-ray absorptiometry (DXA) (in the previous 24 weeks). - On stable cART based on TDF+3TC or FTC+r/PI for at least 24 weeks. - Having plasma HIV-1 RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy, breast-feeding status or plans for pregnancy in the short term. - Primary genotypic resistance mutations and/or previous virological failures to ATV or 3TC/FTC. - Chronic hepatitis B infection. - Patients with indication for therapy for the prevention of bone fractures. - 25-OH vitamin D deficiency (< 10ng/mL), - Hypogonadism (low total testosterone according to local reference range), untreated. - Hypothyroidism (low T4 and increased thyroid stimulating hormone levels according to local reference ranges) - Hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges). - Having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more). - Using anti-resorptive therapy (Calcium and vitamin D supplements are encouraged but not mandated) - BMI lower than 19.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients free of virologic failure (confirmed VL? 50 copies/mL) at 48 weeks - Proportion of patients with adverse effects at 48 weeks - Changes in bone turnover markers (BTMs): urinary N-terminal telopeptide of type-1 collagen (NTX), and bone-specific alkaline phosphatase at 48 weeks. - Changes from baseline to week 48 in: (i) estimated glomerular filtration rate (eGFR) and phosphorus in blood sample; (ii) proximal tubule dysfunction parameters: glucose, protein, albumin, creatinin, phosphorus, beta-2 microglobuline and NAG in urine samples.;Timepoint(s) of evaluation of this end point: - Proportion of patients free of virologic failure (confirmed VL? 50 copies/mL) at 48 weeks - Proportion of patients with adverse effects at 48 weeks - Changes in bone turnover markers (BTMs): urinary N-terminal telopeptide of type-1 collagen (NTX), and bone-specific alkaline phosphatase at 48 weeks. - Changes from baseline to week 48 in: (i) estimated glomerular filtration rate (eGFR) and phosphorus in blood sample; (ii) proximal tubule dysfunction parameters: glucose, protein, albumin, creatinin, phosphorus, beta-2 microglobuline and NAG in urine samples. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change in BMD by dual-energy X-ray (DXA) absorptiometry in HIV-infected adults with hip or spine T-score < -1.0 by DXA at week 48 after switching to r/ATV plus lamivudine.;Secondary Objective: To assess the effects of switching on: - Proportion of patients free of virologic failure (confirmed VL? 50 copies/mL) at 48 weeks - Adverse effects at 48 weeks - Bone turnover markers (BTMs): urinary N-terminal telopeptide of type-1 collagen (NTX), and bone-specific alkaline phosphatase at 48 weeks. - (i) Estimated glomerular filtration rate (eGFR) and phosphorus in blood sample; (ii) proximal tubule dysfunction parameters: glucose, protein, albumin, creatinin, phosphorus, beta-2 microglobuline and NAG in urine samples. at week 48 when compared to baseline;Primary end point(s): Change in BMD by dual-energy X-ray (DXA) absorptiometry at week 48.;Timepoint(s) of evaluation of this end point: Change in BMD by dual-energy X-ray (DXA) absorptiometry at week 48. | — |
Countries
Spain
Contacts
Public ContactJaime Camacho
CTU Clinic (Clinical Trial Unit)
Outcome results
None listed