Phase 4
Completed N=49
Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r
Source: ClinicalTrials.gov NCT00756730 ↗Enrolled (actual)
49
Serious AEs
4.1%
Results posted
Jul 2012
Primary outcomePrimary: Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24. — 80; 73 percentage of patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24. |
80; 73 | — |
| PRIMARY At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL |
48; 55 | — |
| PRIMARY The Change in Fasting Triglyceride Level From Baseline to Week 24 |
-126; -88 | — |
| SECONDARY Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24 |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Difference in CD4 From Baseline to Week 24 |
10.75; 14.28 | — |
| SECONDARY Total Cholesterol in the Two Study Groups at 24 Weeks |
195; 195 | — |
| SECONDARY LDL Cholesterol at Week 24 |
116; 111 | — |
| SECONDARY HDL Cholesterol at Week 24 |
38; 40 | — |
Eligibility Criteria
Inclusion Criteria
- Currently receiving Antiretroviral Therapy (ART) regimen including LPV/r or FPV/r and > or equal to 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Patient must be on a stable regimen containing LPV/r or FPV/r for at least 12 weeks prior to screening.
- Documentation of an undetectable Human Immunodeficiency Virus (HIV) viral load (VL 200 mg/dL
- No ongoing issues that in the opinion of the investigator would lead to decreased ability to comply with the study procedures
- If currently receiving a proton pump inhibitor, the dose is or equal to two NRTIs and either LPV/r or FPV/r
- Prior use of darunavir or atazanavir
- CDC Class C Illness diagnosed within 30 days of screening
- Patient is currently receiving the following Hydroxamethylglutaryl-coA (HMGCoA) reductase inhibitor medications (statins): pravastatin, lovastatin, simvastatin
- Patient is currently receiving a bile acid sequestrant (cholestyramine, colestipol, and colesevelam)
- Grade 3 or 4 Laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table with the following exceptions:
- Pre-existing diabetes mellitus with asymptomatic, nonfasting glucose grade 3 elevations
- Subjects with asymptomatic grade 3 fasting triglyceride or cholesterol elevations
- Clinical or laboratory evidence of clinically significant liver impairment/dysfunction disease or cirrhosis
- Note: Individuals co-infected with chronic hepatitis B or C viruses will be allowed to enter the trial if their condition is clinically stable and they will not require therapy during the course of the study. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase
- Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance
- Use of any investigational agents 30 days prior to screening
- Life expectancy < 6 months in the opinion of the investigator
- Pregnancy or breast feeding
- Female subject of childbearing potential (i.e., heterosexually active, and not surgically sterile or at least two years post-menopausal) not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity
Data sourced from ClinicalTrials.gov (NCT00756730). 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.