Phase 3
Completed N=256
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
HIV · AIDS Virus · Human Immunodeficiency Virus Infection · Acquired Immunodeficiency Syndrome Virus
Source: ClinicalTrials.gov NCT00458302 ↗
Enrolled (actual)
256
Serious AEs
10.9%
Results posted
Feb 2010
Primary outcomePrimary: Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48] — 108; 106 participants
Summary
The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50 copies/ml for at least 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48] |
108; 106 | — |
| SECONDARY Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48] |
110; 107 | — |
| SECONDARY Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144] |
94; 88 | — |
| SECONDARY Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144] |
106; 106 | — |
| SECONDARY Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144] |
102; 95 | — |
| SECONDARY Mean Change From Baseline in CD4+ Cell Count |
-16.9; -32.9; -23.6; -20.7; -5.4; -35.8 | — |
| SECONDARY Resistance Determinations |
42; 48; 23; 31; 1; 1 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score |
1.7; 1.7; 0.4; 3.5; 0.7; 3.1 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale |
0.1; -0.1; -0.1; -0.1; 0.1; -0.1 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale |
0.1; 1.8; 1.0; 1.3; 1.4; 1.7 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale |
0.3; -0.8; -0.1; 0.4; -0.6; 0.0 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale |
0.6; 1.0; 0.4; 1.4; 0.0; 1.0 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale |
0.4; -0.2; -0.6; 0.8; -0.3; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with documented HIV-1 infection
- Patients currently receiving HAART for at least 24 weeks
- Plasma viral load 100/mm3 at the start of HAART and > 200/mm3 at screening.
Exclusion Criteria
- No history of virological failure defined as two consecutive plasma HIV-1 RNA > 500 copies/mL while on previous or current antiretroviral therapy
- No history of any primary PI mutations as defined by the IAS-USA guidelines 2006
- No patients co-infected with hepatitis B
- No pregnant or breastfeeding women
- No active clinically significant disease or life threatening disease or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study.
Data sourced from ClinicalTrials.gov (NCT00458302). 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.