Trial Outcomes & Findings for HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine (NCT NCT00855413)

NCT ID: NCT00855413

Last Updated: 2017-10-17

Results Overview

Virologic response defined as plasma HIV RNA measurement \<200 copies/mL at week 24

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2017-10-17

Participant Flow

Individuals diagnosed with acute HIV in clinical sites within 30 days of enrollment and at least 18 years of age were enrolled. Acute HIV defined as: i) negative EIA and positive NAT; ii) positive EIA and positive NAT with negative/indeterminate western blot (WB); or iii) positive EIA, positive WB and EIA negative documentation in prior 30 days.

Participant milestones

Measure	Acute HIV Infection Treatment Group All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

years

Baseline characteristics by cohort

Measure	Acute HIV Infection Treatment Group n=15 Participants All participants were administered darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis and continued for 48 weeks. Participants were evaluated on study at weeks 2, 4, 8, 12, 16, 24 and 48.
Age, Continuous Age	23 years n=5 Participants • years
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: All participants enrolled were included in analysis of virologic response

Virologic response defined as plasma HIV RNA measurement <200 copies/mL at week 24

Outcome measures

Measure	Acute HIV Infection Treatment Group n=15 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Number of Participants With Virologic Response	13 Participants

SECONDARY outcome

Timeframe: 48 weeks from enrollment

Population: All participants retained on study through week 48 were included in the analysis of virologic efficacy at week 48

Virologic response to study treatment defined as plasma HIV RNA measurement <50 copies/mL at week 48

Outcome measures

Measure	Acute HIV Infection Treatment Group n=12 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Number of Participants With Virologic Response	9 Participants

SECONDARY outcome

Timeframe: week 0, week 24

Population: All participants enrolled were included in this analysis

Outcome measures

Measure	Acute HIV Infection Treatment Group n=15 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Median Change in CD4 Cell Count From Week 0 to Week 24.	158 cells/mm^3 Interval -281.0 to 916.0

SECONDARY outcome

Timeframe: 48 weeks from enrollment

Population: 12 participants with a week 48 study visit were included in analysis

Outcome measures

Measure	Acute HIV Infection Treatment Group n=12 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Median Change in CD4 Cell Count From Week 0 to Week 48.	349 cells/mm^3 Interval 7.0 to 495.0

SECONDARY outcome

Timeframe: HIV RNA level at enrollment

Outcome measures

Measure	Acute HIV Infection Treatment Group n=15 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
HIV RNA Levels Immediately Prior to Initiating Study Treatment.	1,000,000 copies/mL

SECONDARY outcome

Timeframe: From enrollment to the date of HIV RNA suppression, assessed up to Week 48

Outcome measures

Measure	Acute HIV Infection Treatment Group n=15 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Median Time to HIV RNA Suppression to <200 Copies/mL	59 days Interval 15.0 to 187.0

SECONDARY outcome

Timeframe: From enrollment through 48 weeks

Population: Study stopped prior to target enrollment by sponsor. Given insufficient semen samples, correlation of HIV viremia in semen with time to suppression was not performed due to inadequate power to analyze the outcome.

Total cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
HIV RNA Detection in Semen	2541 copies/mL Interval 0.0 to 7470.0

SECONDARY outcome

Timeframe: Enrollment to Week 48

Outcome measures

Measure	Acute HIV Infection Treatment Group n=15 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance	1 Participants

SECONDARY outcome

Timeframe: Enrollment to week 48

Total number of adverse events observed that were possibly or definitely related to study treatment through week 48

Outcome measures

Measure	Acute HIV Infection Treatment Group n=15 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48	13 adverse events

SECONDARY outcome

Timeframe: Week 4 and week 48

Population: 4 participants consented to 7 optional lumbar punctures to provide CSF samples for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture	25 ng/mL

SECONDARY outcome

Timeframe: Week 4 and week 48

Population: 4 participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture	4 ng/mL

SECONDARY outcome

Timeframe: Week 4 and week 48

Population: Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture	240 ng/mL

SECONDARY outcome

Timeframe: Week 4 and week 48

Population: Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture	10 ng/mL

SECONDARY outcome

Timeframe: Week 4 and Week 48

Population: Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture	22 ng/mL

SECONDARY outcome

Timeframe: Week 4 and week 48

Population: Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture	2 ng/mL

SECONDARY outcome

Timeframe: Weeks 0-4 and weeks 12, 48

Population: Four participants consented to provide a semen sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen	185 ng/mL

SECONDARY outcome

Timeframe: Weeks 0-4 and weeks 12, 48

Population: Four participants consented to provide a semen sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen	12 ng/mL

SECONDARY outcome

Timeframe: Weeks 0-4 and weeks 12, 48

Population: Four participants consented to provide a semen sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen	1296 ng/mL

SECONDARY outcome

Timeframe: Weeks 0-4 and weeks 12, 48

Population: Four participants consented to provide a semen sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen	9 ng/mL

SECONDARY outcome

Timeframe: Weeks 0-4 and Weeks 12, 48

Population: Four participants consented to provide a semen sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen	22 ng/mL

SECONDARY outcome

Timeframe: Weeks 0-4 and Weeks 12, 48

Population: Four participants consented to provide a semen sample for measurement of drug levels.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen	2 ng/mL

SECONDARY outcome

Timeframe: between Week 4-12 and between Weeks 36-48

Population: Six participants consented to ileal biopsy for measurement of drug levels

Outcome measures

Measure	Acute HIV Infection Treatment Group n=6 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure	83,749 ng/g

SECONDARY outcome

Timeframe: between Week 4-12 and between Weeks 36-48

Population: Six participants consented to ileal biopsy for measurement of drug levels

Outcome measures

Measure	Acute HIV Infection Treatment Group n=6 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure	34 ng/g

SECONDARY outcome

Timeframe: between Week 4-12 and between Weeks 36-48

Population: Six participants consented to ileal biopsy for measurement of drug levels

Outcome measures

Measure	Acute HIV Infection Treatment Group n=6 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure	83,749 ng/g

SECONDARY outcome

Timeframe: between week 4-12 and between weeks 36-48

Population: Six participants consented to ileal biopsy for measurement of drug levels

Outcome measures

Measure	Acute HIV Infection Treatment Group n=6 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure	987 ng/g

SECONDARY outcome

Timeframe: between week 4-12 and between Weeks 36-48

Population: Six participants consented to ileal biopsy for measurement of drug levels

Outcome measures

Measure	Acute HIV Infection Treatment Group n=6 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure	14,698 ng/g

SECONDARY outcome

Timeframe: between week 4-12 and between weeks 36-48

Population: Six participants consented to ileal biopsy for measurement of drug levels

Outcome measures

Measure	Acute HIV Infection Treatment Group n=6 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure	96 ng/g

SECONDARY outcome

Timeframe: Week 4 and Week 48

Population: Four participants provided 7 CSF samples for measurement of HIV RNA level

Outcome measures

Measure	Acute HIV Infection Treatment Group n=4 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid	0 participants

SECONDARY outcome

Timeframe: Week 2 or 4

Population: Participants who consented to optional procedure of neurocognitive assessment at baseline

Outcome measures

Measure	Acute HIV Infection Treatment Group n=13 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Number of Participants With Neurocognitive Impairment at Baseline	8 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants who consented to optional procedure of neurocognitive assessment at week 24

Outcome measures

Measure	Acute HIV Infection Treatment Group n=9 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Number of Participants With Neurocognitive Impairment at Week 24	3 Participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants who consented to optional procedure of neurocognitive assessment at week 48

Outcome measures

Measure	Acute HIV Infection Treatment Group n=10 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Number of Participants With Neurocognitive Impairment at Week 48	3 Participants

SECONDARY outcome

Timeframe: Week 2 or 4

Population: participants who underwent neurocognitive assessment at week 2 or 4

Neuropsychological performance was assessed at Week 2 or 4, Week 24 and Week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test-Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=10 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Overall Neurocognitive Impairment Score at Week 2 or 4	-0.69 z score Standard Deviation .14

SECONDARY outcome

Timeframe: Week 24

Population: participants who underwent neurocognitive assessment at baseline and week 24

Neuropsychological performance was assessed at week 2 or 4, week 24 and week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=9 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Overall Neurocognitive Impairment at Week 24	-0.40 z score Standard Deviation .15

SECONDARY outcome

Timeframe: Week 48

Population: participants who underwent neurocognitive assessment at baseline and week 48

Neuropsychological performance was assessed at baseline (week 2 or 4), week 24 and week 48 in the following domain (measures): Premorbid/language (Wide Range Achievement Test (WRAT) 4 - Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test - Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=10 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Overall Neurocognitive Impairment at Week 48	-.45 z score Standard Deviation .15

SECONDARY outcome

Timeframe: Baseline to Week 24 or 48

Population: Participants who underwent neurocognitive assessment at baseline and Week 24 and/or 48.

Change in overall z score from baseline to week 24 or 48. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=11 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48	4.23 z score Standard Deviation .15

SECONDARY outcome

Timeframe: From enrollment through Week 48

Population: Participants who consented to neurocognitive assessments at baseline and week 24 or 48. Sponsor stopped study prior to target enrollment.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=11 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning	NA r value Insufficient CSF samples which were all below detectible limits for HIV RNA assay resulted in insufficient power to assess for correlations

SECONDARY outcome

Timeframe: Baseline to Week 24 and 48

Population: Participants who consented to optional neurocognitive assessments at baseline and week 24 or 48

Outcome measures

Measure	Acute HIV Infection Treatment Group n=11 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48	-.82 r value

SECONDARY outcome

Timeframe: Weeks 4 and 48

Population: Study stopped prior to target enrollment by sponsor. Given insufficient ileal biopsy samples, correlation of HIV viremia in ileal biopsies with time to suppression was not performed due to inadequate power to analyze the outcome.

Average HIV RNA detected in the ileal biopsy specimens per participant over weeks 4 and 48.

Outcome measures

Measure	Acute HIV Infection Treatment Group n=6 Participants Participants received darunavir 800mg, ritonavir 100mg once daily plus etravirine as 400mg once daily or 200mg twice daily started within 30 days of acute HIV diagnosis.
HIV RNA Detection in Ileal Biopsy Specimens	40 copies/mL Interval 0.0 to 506.0

Adverse Events

Darunavir/Ritonavir and Etravirine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Darunavir/Ritonavir and Etravirine n=15 participants at risk Darunavir/Ritonavir and Etravirine DRV/r will be administered 800 mg/100 mg orally once daily. ETR will be given 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen. Darunavir/Ritonavir and Etravirine: DRV/r will be administered 800 mg/100 mg orally once daily. ETR will be given 200 mg orally twice daily, although patients may choose to take ETR 400 mg QD to have a simpler all QD regimen.
Investigations Blood Cholesterol Increased	6.7% 1/15 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.

Additional Information

Dr. Cynthia Gay

The University of North Carolina

Phone: 9198432726

Email: cynthia_gay@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place