Overview

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA

Status:
Completed
Trial end date:
2015-03-18
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag International NV
Treatments:
Darunavir
Reverse Transcriptase Inhibitors
Ritonavir
Criteria
Inclusion Criteria:

- HIV-1 infection

- receiving HAART for at least 48 weeks

- Have at least 2 documented plasma HIV-1 RNA <50 copies/mL, and no HIV-1 RNA >=50
copies/mL in the 48 weeks prior to the screening

- Be taking the same antiretroviral (ARV) combination for at least 8 weeks before
screening

- Have the preference, together with the physician, to change the current HAART regimen
for reasons of simplification and/or toxicity

Exclusion Criteria:

- Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA >500
copies/mL while on previous or current antiretroviral therapy

- Has a history of any primary PI mutations

- Has clinical or laboratory evidence of significantly decreased hepatic function or
decompensation, irrespective of liver enzyme levels (liver insufficiency)

- Is diagnosed with acute viral hepatitis at screening or before Baseline 1

- Is co-infected with hepatitis B