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Randomized, Open-label Study of Switch From Lopinavir/Ritonavir (LPV/r) or Fosamprenavir/Ritonavir (FPV/r) to Either Once Daily Atazanavir/Ritonavir (ATV/r) or Once Daily Darunavir/Ritonavir (DRV/r) (Plus Background Nucleoside Reverse Transcriptase Inhibitors) in Patients Experiencing Triglyceride Elevations While Receiving LPV/r or FPV/r. (LARD)
For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.
Details
| Lead sponsor | Community Research Initiative of New England |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 49 |
| Start date | 2008-09 |
| Completion | 2011-06 |
Conditions
- HIV Infections
Interventions
- ATV/r
- DRV/r
Primary outcomes
- Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24. — baseline, 24 weeks
A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm. - At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL — 24 weeks
- The Change in Fasting Triglyceride Level From Baseline to Week 24 — Baseline to week 24
Countries
United States