Phase 3
Completed N=273
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 on Current Treatment
Human Immunodeficiency Virus (HIV) Infections · Acquired Immunodeficiency Syndrome (AIDS) Virus
Source: ClinicalTrials.gov NCT01448707 ↗
Enrolled (actual)
273
Serious AEs
11.7%
Results posted
Dec 2015
Primary outcomePrimary: Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure) — 87.0; 95.0 Percentage of Participants — p=0.2331
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure) |
75.2; 85.3 | 0.6933 |
| SECONDARY Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure) |
75.2; 85.3 | 0.6933 |
| SECONDARY Virologic Response (FDA Snapshot, Switch Included) |
93.0; 96.5; 89.3; 89.9 | 0.0016 sig |
| SECONDARY Change From Baseline in Global Neurocognitive Performance z-Score |
0.39; 0.42; 0.63; 0.57 | — |
| SECONDARY Time to Loss of Virologic Response |
NA; NA | — |
| SECONDARY Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance |
1; 2; 2; 1; 0; 0 | — |
| SECONDARY Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results |
1; 2; 2; 1; 2; 0 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01448707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.