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HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00855413
Recruitment Status : Terminated (Study halted by sponsor due to slow enrollment.)
First Posted : March 4, 2009
Results First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Cynthia L Gay, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute HIV Infection
HIV Infections
Interventions Drug: Darunavir
Drug: Ritonavir
Drug: Etravirine
Enrollment 15
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description 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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] [2] 
Median (Full Range)
Unit of measure:  Years
Age Number Analyzed 15 participants
23
(19 to 51)
[1]
Measure Description: Median age and range of all participants enrolled in study
[2]
Measure Analysis Population Description: years
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
2
  13.3%
Male
13
  86.7%
[1]
Measure Description: Gender of participants enrolled onto the study
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
3
  20.0%
Not Hispanic or Latino
12
  80.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  73.3%
White
4
  26.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
[1]
Measure Description: Region of enrollment for all participants
1.Primary Outcome
Title Number of Participants With Virologic Response
Hide Description Virologic response defined as plasma HIV RNA measurement <200 copies/mL at week 24
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled were included in analysis of virologic response
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
13
  86.7%
2.Secondary Outcome
Title Number of Participants With Virologic Response
Hide Description Virologic response to study treatment defined as plasma HIV RNA measurement <50 copies/mL at week 48
Time Frame 48 weeks from enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants retained on study through week 48 were included in the analysis of virologic efficacy at week 48
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
9
  75.0%
3.Secondary Outcome
Title Median Change in CD4 Cell Count From Week 0 to Week 24.
Hide Description [Not Specified]
Time Frame week 0, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled were included in this analysis
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: cells/mm^3
158
(-281 to 916)
4.Secondary Outcome
Title Median Change in CD4 Cell Count From Week 0 to Week 48.
Hide Description [Not Specified]
Time Frame 48 weeks from enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
12 participants with a week 48 study visit were included in analysis
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: cells/mm^3
349
(7 to 495)
5.Secondary Outcome
Title HIV RNA Levels Immediately Prior to Initiating Study Treatment.
Hide Description [Not Specified]
Time Frame HIV RNA level at enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: copies/mL
1,000,000
(22,858 to 29,807,640)
6.Secondary Outcome
Title Median Time to HIV RNA Suppression to <200 Copies/mL
Hide Description [Not Specified]
Time Frame From enrollment to the date of HIV RNA suppression, assessed up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: days
59
(15 to 187)
7.Secondary Outcome
Title HIV RNA Detection in Semen
Hide Description Total cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48.
Time Frame From enrollment through 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: copies/mL
2541
(0 to 7470)
8.Secondary Outcome
Title Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance
Hide Description [Not Specified]
Time Frame Enrollment to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.7%
9.Secondary Outcome
Title Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48
Hide Description Total number of adverse events observed that were possibly or definitely related to study treatment through week 48
Time Frame Enrollment to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: adverse events
13
10.Secondary Outcome
Title Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Hide Description [Not Specified]
Time Frame Week 4 and week 48
Hide Outcome Measure Data
Hide Analysis Population Description
4 participants consented to 7 optional lumbar punctures to provide CSF samples for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
25
11.Secondary Outcome
Title Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Hide Description [Not Specified]
Time Frame Week 4 and week 48
Hide Outcome Measure Data
Hide Analysis Population Description
4 participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
4
12.Secondary Outcome
Title Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Hide Description [Not Specified]
Time Frame Week 4 and week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
240
13.Secondary Outcome
Title Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Hide Description [Not Specified]
Time Frame Week 4 and week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
10
14.Secondary Outcome
Title Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Hide Description [Not Specified]
Time Frame Week 4 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
22
15.Secondary Outcome
Title Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture
Hide Description [Not Specified]
Time Frame Week 4 and week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
2
16.Secondary Outcome
Title Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Hide Description [Not Specified]
Time Frame Weeks 0-4 and weeks 12, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to provide a semen sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
185
17.Secondary Outcome
Title Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Hide Description [Not Specified]
Time Frame Weeks 0-4 and weeks 12, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to provide a semen sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
12
18.Secondary Outcome
Title Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Hide Description [Not Specified]
Time Frame Weeks 0-4 and weeks 12, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to provide a semen sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
1296
19.Secondary Outcome
Title Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen
Hide Description [Not Specified]
Time Frame Weeks 0-4 and weeks 12, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to provide a semen sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
9
20.Secondary Outcome
Title Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Hide Description [Not Specified]
Time Frame Weeks 0-4 and Weeks 12, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to provide a semen sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
22
21.Secondary Outcome
Title Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen
Hide Description [Not Specified]
Time Frame Weeks 0-4 and Weeks 12, 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants consented to provide a semen sample for measurement of drug levels.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: ng/mL
2
22.Secondary Outcome
Title Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Hide Description [Not Specified]
Time Frame between Week 4-12 and between Weeks 36-48
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants consented to ileal biopsy for measurement of drug levels
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/g
83,749
23.Secondary Outcome
Title Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Hide Description [Not Specified]
Time Frame between Week 4-12 and between Weeks 36-48
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants consented to ileal biopsy for measurement of drug levels
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/g
34
24.Secondary Outcome
Title Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Hide Description [Not Specified]
Time Frame between Week 4-12 and between Weeks 36-48
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants consented to ileal biopsy for measurement of drug levels
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/g
83,749
25.Secondary Outcome
Title Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Hide Description [Not Specified]
Time Frame between week 4-12 and between weeks 36-48
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants consented to ileal biopsy for measurement of drug levels
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/g
987
26.Secondary Outcome
Title Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Hide Description [Not Specified]
Time Frame between week 4-12 and between Weeks 36-48
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants consented to ileal biopsy for measurement of drug levels
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/g
14,698
27.Secondary Outcome
Title Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure
Hide Description [Not Specified]
Time Frame between week 4-12 and between weeks 36-48
Hide Outcome Measure Data
Hide Analysis Population Description
Six participants consented to ileal biopsy for measurement of drug levels
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: ng/g
96
28.Secondary Outcome
Title Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid
Hide Description [Not Specified]
Time Frame Week 4 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants provided 7 CSF samples for measurement of HIV RNA level
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
0
29.Secondary Outcome
Title Number of Participants With Neurocognitive Impairment at Baseline
Hide Description [Not Specified]
Time Frame Week 2 or 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who consented to optional procedure of neurocognitive assessment at baseline
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
8
  61.5%
30.Secondary Outcome
Title Number of Participants With Neurocognitive Impairment at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who consented to optional procedure of neurocognitive assessment at week 24
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
3
  33.3%
31.Secondary Outcome
Title Number of Participants With Neurocognitive Impairment at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who consented to optional procedure of neurocognitive assessment at week 48
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
3
  30.0%
32.Secondary Outcome
Title Overall Neurocognitive Impairment Score at Week 2 or 4
Hide Description 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.
Time Frame Week 2 or 4
Hide Outcome Measure Data
Hide Analysis Population Description
participants who underwent neurocognitive assessment at week 2 or 4
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: z score
-0.69  (.14)
33.Secondary Outcome
Title Overall Neurocognitive Impairment at Week 24
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
participants who underwent neurocognitive assessment at baseline and week 24
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: z score
-0.40  (.15)
34.Secondary Outcome
Title Overall Neurocognitive Impairment at Week 48
Hide Description 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.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
participants who underwent neurocognitive assessment at baseline and week 48
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: z score
-.45  (.15)
35.Secondary Outcome
Title Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48
Hide Description 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.
Time Frame Baseline to Week 24 or 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent neurocognitive assessment at baseline and Week 24 and/or 48.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: z score
4.23  (.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acute HIV Infection Treatment Group
Comments An overall summary score of neurocognitive functioning was created by averaging all tests. Best available demographically corrected normative data were utilized to create z scores and then deficit scores for impairment ratings.Change in neurocognitive functioning was analyzed using a one sided repeated measures ANOVA with neurocognitive performance as the dependent variable (total z score) and time (visit) as the independent variable. Degrees of freedom were 2,17.
Type of Statistical Test Other
Comments one sided ANOVA.
Statistical Test of Hypothesis P-Value 0.03
Comments The degrees of freedom (df) for the within factor (number of visits - 1) was 2, and the second df is the error df of 17.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.23
Parameter Dispersion
Type: Standard Deviation
Value: 0.15
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning
Hide Description [Not Specified]
Time Frame From enrollment through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who consented to neurocognitive assessments at baseline and week 24 or 48. Sponsor stopped study prior to target enrollment.
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: r value
NA [1] 
[1]
Insufficient CSF samples which were all below detectible limits for HIV RNA assay resulted in insufficient power to assess for correlations
37.Secondary Outcome
Title Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48
Hide Description [Not Specified]
Time Frame Baseline to Week 24 and 48
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Participants who consented to optional neurocognitive assessments at baseline and week 24 or 48
Arm/Group Title Acute HIV Infection Treatment Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: r value
-.82
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Statistical Analysis Overview Comparison Group Selection Acute HIV Infection Treatment Group
Comments Correlation between time (days) to HIV RNA suppression <200 copies/mL and total z score (mean) was assessed by Spearman correlation
Type of Statistical Test Other
Comments Spearman correlation
Statistical Test of Hypothesis P-Value <.005
Comments R = -0.82
Method Spearman correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter spearman correlation
Estimated Value -.82
Estimation Comments [Not Specified]
Other Statistical Analysis Correlation between time (days) to HIV RNA suppression <200 copies/mL and total z score (mean) was assessed by Spearman correlation
38.Secondary Outcome
Title HIV RNA Detection in Ileal Biopsy Specimens
Hide Description Average HIV RNA detected in the ileal biopsy specimens per participant over weeks 4 and 48.
Time Frame Weeks 4 and 48
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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.
Arm/Group Title Acute HIV Infection Treatment Group
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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 Number of Participants Analyzed 6
Mean (Full Range)
Unit of Measure: copies/mL
40
(0 to 506)
Time Frame Adverse events were collected for each participant over the 96 weeks of the study.
Adverse Event Reporting Description 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.
 
Arm/Group Title Darunavir/Ritonavir and Etravirine
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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.

All-Cause Mortality
Darunavir/Ritonavir and Etravirine
Affected / at Risk (%)
Total   0/15 (0.00%)    
Hide Serious Adverse Events
Darunavir/Ritonavir and Etravirine
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Darunavir/Ritonavir and Etravirine
Affected / at Risk (%) # Events
Total   4/15 (26.67%)    
Gastrointestinal disorders   
Nausea  1  1/15 (6.67%)  1
Investigations   
Blood Cholesterol Increased  1  1/15 (6.67%)  1
Nervous system disorders   
Dizziness  1  1/15 (6.67%)  1
Headache  1  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/15 (6.67%)  1
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Early termination prior to target enrollment due to slow enrollment limited analysis involving optional procedures. Lack of paired (baseline and followup) samples from optional procedures also limited ability to perform these analyses.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Dr. Cynthia Gay
Organization: The University of North Carolina
Phone: 9198432726
EMail: cynthia_gay@med.unc.edu
Publications:
C Gay, A Johnson, S McCoy, J Kuruc, K McGee, L McNeil, M Kerkau, J Sebastian, C Pilcher, D Margolis, P Leone, S Fiscus, G Ferrari, C Hicks, J Eron, The Duke-UNC Acute HIV Infection Consortium. "Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0082.
C Gay, O Dibben, A Stacey, N Gasper-Smith, M Liu, N Goonetilleke, G Ferrari, J Eron, C Hicks, A McMichael, B Haynes, P Borrow, M Cohen, the Duke-UNC CHAVI 001 Clinical Working Group. "Effect(s) of antiretroviral treatment on acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0086.
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Responsible Party: Cynthia L Gay, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00855413    
Other Study ID Numbers: CID 0821
First Submitted: March 2, 2009
First Posted: March 4, 2009
Results First Submitted: February 24, 2017
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017