Phase 3
Completed N=209
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
HIV · Infection, Human Immunodeficiency Virus
Source: ClinicalTrials.gov NCT00363142 ↗
Enrolled (actual)
209
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 — 92.1; 94.2 Percentage of participants
Summary
This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 |
92.1; 94.2 | — |
| SECONDARY Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis |
92; 94.2; 8; 5.8 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis |
82.9; 84.6; 17.1; 15.4 | — |
| SECONDARY Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis |
-0.015; -0.022 | — |
| SECONDARY Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis |
11.5; 15 | — |
| SECONDARY Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 |
2; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 |
48; 24; 8; 2; 3; 3 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 |
-0.5; 0.7; -2.1; 0; -13.5; -0.6 | — |
| SECONDARY Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24 |
0; 2.1 | — |
| SECONDARY Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline |
— | — |
| SECONDARY Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 |
1.38; 1.28; 1.35; 1.27; 1.49; 2.38 | — |
Eligibility Criteria
Inclusion criteria
- Subjects with HIV-1 infection.
- Are willing and able to understand and provide written consent prior to participation in this study.
Exclusion criteria
- Are pregnant or breastfeeding.
- Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.
- Have certain medical conditions that may make participation unsafe.
- Take medication that may interact with the study medication.
- Have a history of allergy to any of the study drugs or any excipients therein.
- Other inclusion/exclusion criteria to be evaluated by the physician.
Data sourced from ClinicalTrials.gov (NCT00363142). 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.