Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.

Open Label Phase 3b, 48 wk Pilot Study of the Antiviral Efficacy and Tolerability of Combination of PREZISTA/r and TMC125 When Substituted for Enfuvirtide, Current Protease Inhibitor(s) and NNRTI(s) in Antiretroviral Resistant Patients With Viral Suppression But Who Are Intolerant of Enfuvirtide.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00460746

Enrollment

Registered

2007-04-16

Start date

2007-05-31

Completion date

2008-10-31

Last updated

2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, AIDS, Immunodeficiency Virus, Human, PREZISTA, darunavir, TMC114, TMC125, Protease Inhibitor, Non-Nucleoside Reverse Transcriptase Inhibitor, enfuvirtide, Treatment Experienced

Brief summary

The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.

Detailed description

This is a multi-center, open-label (doctors and patients know which drug is being given), Phase IIIb clinical trial to evaluate the effectiveness, safety and tolerability of the combination of PREZISTA (darunavir)/ritonavir and TMC125 when substituted for enfuvirtide, current protease inhibitor(s) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) in antiretroviral resistant patients with viral suppression but who are intolerant of enfuvirtide. This study will be conducted in the U.S. at up to 5 sites where 40 patients will receive PREZISTA (darunavir) /ritonavir twice daily (600/100mg) and TMC125 (200 mg) twice daily over a 48-week treatment period. The study will consist of a total of 11 patient visits. At the screening visit (Week -1 to -6) blood will be collected from patients to determine eligibility. Once all data are available to determine the eligibility of the patient, the baseline visit will be scheduled and trial treatment initiated at this visit. The Baseline Visit (Day 1) will be followed by a 48-week treatment period. The patient will be evaluated at Weeks 2, 4, 8, 12, 16, 24, 36, and 48. Patients will be asked to return for a 2-week follow up visit at Week 50. Treatment will include PREZISTA (darunavir) /ritonavir and TMC125 plus continued nucleosides. The patient must continue all existing nucleosides in their background regimen for the duration of the study. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits. Study patients will receive oral (by mouth) PREZISTA (darunavir) 600 mg and 100 mg of ritonavir twice a day in combination with TMC125 200mg orally twice a day for 48 weeks.

Interventions

DRUGTMC125, Darunavir; Ritonavir

TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented HIV-1 positive * History of drug resistance or antiretroviral failure while receiving each of three drug classes: Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and (protease inhibitors) PIs * On a PI containing regimen with enfuvirtide with HIV viral load (VL) \< 400 copies/mL for 6 months or longer * Continuously using the same PI regimen for 4 months prior to Screening * Decline to continue enfuvirtide or their physician recommends discontinuation due to injection site reactions that persist despite optimal technique and training with available methods of administration or loss of sites for injection due to tissue nodules and hardening.

Exclusion criteria

* No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 * No prior or current therapy with PREZISTA (darunavir) or TMC125 * No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). Patients with \> 3 darunavir resistance-associated mutations with available darunavir phenotypes, may be enrolled if the resistance phenotype demonstrates: Fold Change (FC) \<10 to darunavir by PhenoSense GT (Monogram Biosciences) or FC \<10 to darunavir by Antivirogram (Virco, BVBA) or FC \<3.4 to darunavir by vircoTYPE (Virco BVBA) * AST or ALT \>5 times ULN * Calculated CrCl \< 30 ml/min.

Design outcomes

Primary

Measure	Time frame
Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	48 weeks

Secondary

Measure	Time frame
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 48
CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 48
Median Change From Baseline in Triglycerides at Week 48.	Week 48
Median Change From Baseline in Total Cholesterol at Week 48.	Week 48
Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	48 weeks
Median Change From Baseline in HDL Cholesterol.	Week 48
Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.	Week 48
Median Change From Baseline in Glucose at Week 48.	Week 48
Median Change From Baseline in LDL Cholesterol at Week 48.	Week 48

Countries

United States

Participant flow

Participants by arm

Arm	Count
Darunavir(TMC114)/Eravirine(TMC125) Darunavir/ritonavir (DRV/r) combined with Etravirine (\[ETR\] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.	10
Total	10

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Darunavir(TMC114)/Eravirine(TMC125)
Age Continuous	48 years
CD4 count	301 cells/mm^3
Race/Ethnicity, Customized Hispanic	4 participants
Race/Ethnicity, Customized White	6 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	10 Participants
Viral Load <50 copies/mL	10 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	10 / 10
serious Total, serious adverse events	1 / 10

Outcome results

Primary

Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

Time frame: 48 weeks

Population: ITT population. One subject (001) who discontinued due to adverse events had a VL \< 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL \<50 copies/mL through Week 36.

Arm	Measure	Group	Value (NUMBER)
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Baseline (Day 1)	100 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 2	100 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 4	100 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 8	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 12	80 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 16	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 24	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 36	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 48	80 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Post-Treatment Follow Up	90 percentage of participants

Secondary

CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.

Time frame: Week 48

Population: ITT , LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Baseline (Day 1)	338.3 cells/mm^3	Standard Deviation 135.91
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 4 Change from Baseline	2.3 cells/mm^3	Standard Deviation 31.22
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 8 Change from Baseline	-25.0 cells/mm^3	Standard Deviation 72.04
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 12 Change from Baseline	-18.9 cells/mm^3	Standard Deviation 44.25
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 16 Change from Baseline	0.5 cells/mm^3	Standard Deviation 53.58
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 24 Change from Baseline	24.5 cells/mm^3	Standard Deviation 34
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 36 Change from Baseline	22.7 cells/mm^3	Standard Deviation 58.84
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.	Week 48 Change from Baseline	47.3 cells/mm^3	Standard Deviation 48.03

Secondary

CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.

Time frame: Week 48

Population: Intent To Treat (ITT), last observation carried forward (LOCF).

Arm	Measure	Group	Value (MEDIAN)
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 48 Change from Baseline	63.5 cells/mm^3
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Baseline (Day 1)	301.0 cells/mm^3
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 4 Change from Baseline	-12.0 cells/mm^3
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 8 Change from Baseline	-32.0 cells/mm^3
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 12 Change from Baseline	-17.0 cells/mm^3
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 16 Change from Baseline	-7.0 cells/mm^3
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 24 Change from Baseline	19.0 cells/mm^3
Darunavir(TMC114)/Eravirine(TMC125)	CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.	Week 36 Change from Baseline	38.0 cells/mm^3

Secondary

Median Change From Baseline in Glucose at Week 48.

Time frame: Week 48

Population: ITT , LOCF.

Arm	Measure	Group	Value (MEDIAN)
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Glucose at Week 48.	Baseline (Day 1)	92.5 mg/dL
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Glucose at Week 48.	Week 48 Change from Baseline	1.0 mg/dL

Secondary

Median Change From Baseline in HDL Cholesterol.

Time frame: Week 48

Population: ITT , LOCF.

Arm	Measure	Group	Value (MEDIAN)
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in HDL Cholesterol.	Baseline (Day 1)	47.5 mg/dL
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in HDL Cholesterol.	Week 48 Change from Baseline	-2.5 mg/dL

Secondary

Median Change From Baseline in LDL Cholesterol at Week 48.

Time frame: Week 48

Population: ITT , LOCF.

Arm	Measure	Group	Value (MEDIAN)
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in LDL Cholesterol at Week 48.	Baseline (Day 1)	100.0 mg/dL
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in LDL Cholesterol at Week 48.	Week 48 Change from Baseline	-9.0 mg/dL

Secondary

Median Change From Baseline in Total Cholesterol at Week 48.

Time frame: Week 48

Population: ITT , LOCF.

Arm	Measure	Group	Value (MEDIAN)
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Total Cholesterol at Week 48.	Baseline (Day 1)	189.0 mg/dL
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Total Cholesterol at Week 48.	Week 48 Change from Baseline	-27.5 mg/dL

Secondary

Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.

Time frame: Week 48

Population: ITT , LOCF.

Arm	Measure	Group	Value (MEDIAN)
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.	Baseline (Day 1)	4.7 ratio of TC and HDL
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.	Week 48 Change from Baseline	-0.3 ratio of TC and HDL

Secondary

Median Change From Baseline in Triglycerides at Week 48.

Time frame: Week 48

Population: ITT , LOCF.

Arm	Measure	Group	Value (MEDIAN)
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Triglycerides at Week 48.	Baseline (Day 1)	229.0 mg/dL
Darunavir(TMC114)/Eravirine(TMC125)	Median Change From Baseline in Triglycerides at Week 48.	Week 48 Change from Baseline	-24.5 mg/dL

Secondary

Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

Time frame: 48 weeks

Arm	Measure	Group	Value (NUMBER)
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Baseline (Day 1)	100 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 2	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 4	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 8	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 12	80 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 16	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 24	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 36	90 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Week 48	80 percentage of participants
Darunavir(TMC114)/Eravirine(TMC125)	Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.	Post-Treatment Follow Up	90 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.

CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.

Median Change From Baseline in Glucose at Week 48.

Median Change From Baseline in HDL Cholesterol.

Median Change From Baseline in LDL Cholesterol at Week 48.

Median Change From Baseline in Total Cholesterol at Week 48.

Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.

Median Change From Baseline in Triglycerides at Week 48.

Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.