Simplification From Tenofovir Plus Lamivudine or Emtricitabine Plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir Plus Lamivudine in Virologically-Suppressed-HIVInfected Adults With Osteopenia

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A 48-week, open label, non comparative prospective trial in stable chronic human immunodeficiency virus-infected patients having achieved complete virological suppression for more than 24 weeks (human immunodeficiency virus-1 RNA <50 c/ml) switching from an antiretroviral regimen containing tenofovir and lamivudine or emtricitabine and boosted protease inhibitor to boosted atazanavir and lamivudine Study visits will take place at screening, baseline, weeks 4, 12, 24, and 48.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Garcia Cinca
• Collaborators: Fundacion Clinic per a la Recerca Biomédica; Jose Luis Blanco - Fundació Clínic per a la Recerca Biomèdica
• Treatments: Atazanavir Sulfate; Emtricitabine; HIV Protease Inhibitors; Lamivudine; Protease Inhibitors; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Human immunodeficiency virus-1-infected subjects with age ≥18 years old

• Hip or spine T-scores between < -1.0 and >-2.5 by dual-energy X-ray absorptiometry (in the previous 24 weeks)

• Stable antiretroviral treatment based on tenofovir and lamivudine or emtricitabine and boosted protease inhibitor for at least 24 weeks.

• Having plasma human immunodeficiency virus-1 RNA <50 copies/mL for at least the previous 24 weeks, including at least two samples.

Exclusion Criteria:

• Pregnancy, breast-feeding status or plans for pregnancy in the short term

• Primary genotypic resistance mutations and/or previous virological failures to atazanavir or lamivudine/emtricitabine

• 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)

• 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)

• Body mass index lower than 19