Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this pilot study is to assess the feasibility, efficacy and safety of
      Darunavir/ritonavir 800/100 mg once daily (DRV/r) monotherapy as a switch-maintenance
      strategy for patients receiving second-line ART at Yaoundé Central Hospital in Cameroon.
      HIV-infected adults receiving second-line antiretroviral therapy (ART) for ≥3 months with 2
      nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir
      (LPV/r) or atazanavir/ritonavir (ATV/r) will undergo plasma HIV-1 RNA ("viral") load testing.
      Those with a viral load below 50 copies/ml (<50 cps/ml) will undergo a repeat test ideally
      4-6 weeks later (allowed up to 12 weeks); if the viral load is confirmed as <50 cps/ml the
      patient will be invited to join the randomised phase of the study. Patients (n=150) will be
      randomised 1:2 to either continue the current triple ART regimen (n=50) or switch to DRV/r
      monotherapy (n=100). The primary end-point will be viral load suppression <400 cps/ml at week
      24; secondary end-points will be viral load suppression <50 cps/ml at week 12 and week 24,
      safety, tolerability, and emergence of protease inhibitor (PI) drug-resistance. Patients will
      continue observational follow-up depending on the treatment arm they are randomized to. After
      week 48, patients will return to local standard of care. Pharmacokinetics (PK) and
      pharmacogenomics sub-study to correlate plasma concentrations of DRV to outcomes, HIV-1 drug
      resistance testing sub study to detect mutants archived at the time of first-line ART failure
      and measuring HIV DNA load will be performed, as well as a cost-effectiveness analysis will
      test the hypothesis that savings can be achieved by switching to DRV/r monotherapy without
      affecting quality of care. The primary virological objective is to evaluate efficacy in terms
      of the percentage of subjects who have plasma HIV-1 RNA levels <400 cps/ml after 24 weeks of
      follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing
      2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method).

      Study hypothesis:

      we propose that maintenance therapy with DRV/r monotherapy is a feasible, effective and safe
      treatment option for patients receiving second-line ART in Yaoundé.
    


Intervention name(s): Darunavir; ART with 2 NRTIs plus LPV/r (or ATV/r)
Intervention type(s): Drug; Drug
Intervention description(s): Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.; Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
Other intervention name(s): PREZISTA; NRTI, lopinavir/ritonavir (LPV/r), atazanavir/ritonavir (ATV/r)
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Darunavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy; Safety; Darunavir; HIV-1 RNA level; Cameroon