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Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder (ParaFlu)

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ClinicalTrials.gov Identifier: NCT01354314
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : May 12, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ned Sacktor, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition HIV Associated Neurocognitive Disorder
Interventions Drug: Fluconazole
Drug: Paroxetine
Drug: Paroxetine and Fluconazole
Drug: Placebo
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Period Title: Overall Study
Started 12 11 11 11
Completed (ITT) [1] 11 11 9 10
Completed [2] 6 8 3 5
Not Completed 6 3 8 6
Reason Not Completed
Lost to Follow-up             1             0             1             1
Withdrawal by Subject             0             0             1             0
Adverse Event             0             0             0             1
Protocol Violation             1             1             0             0
Less than 90% Adherence             4             2             6             4
[1]
Completed trial with evaluable data for intention to treat analysis.
[2]
Per protocol: evaluable outcome measures and 90+ percent of target study treatment total dose.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo Total
Hide Arm/Group Description

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Total of all reporting groups
Overall Number of Baseline Participants 12 11 11 11 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
49.83  (5.77) 52.00  (6.62) 51.73  (5.76) 48.73  (10.23) 50.56  (7.17)
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
25 to 34 0 0 0 1 1
35 to 44 2 1 1 1 5
45 to 54 8 7 7 5 27
55 to 64 2 3 3 4 12
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
Male 4 9 10 9 32
Female 7 2 1 1 11
Transgender (Male to Female) 1 0 0 1 2
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
Hispanic or Latino
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
Not Hispanic or Latino
11
  91.7%
11
 100.0%
11
 100.0%
11
 100.0%
44
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
1
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  83.3%
8
  72.7%
10
  90.9%
9
  81.8%
37
  82.2%
White
2
  16.7%
3
  27.3%
1
   9.1%
1
   9.1%
7
  15.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Education  
Mean (Standard Deviation)
Unit of measure:  Years Completed
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
11.83  (2.08) 12.36  (1.80) 12.91  (1.87) 12.36  (2.11) 12.36  (1.94)
Years Since HIV Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
15.33  (6.77) 16.36  (7.90) 15.45  (6.76) 17.36  (7.93) 16.11  (7.14)
[1]
Measure Description: Based on self-report from participants.
Absolute CD4 Count  
Mean (Standard Deviation)
Unit of measure:  Cells per cubic mm
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
516.1  (244.8) 637.3  (241.7) 555.2  (282.8) 510.4  (235.1) 553.9  (248.2)
Plasma HIV Viral Load  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
Undetectable (<50 copies/mL) 7 9 11 10 37
Detectable: 50-99 copies/mL 3 0 0 1 4
Detectable: 100-249 copies/mL 0 2 0 0 2
Detectable: 250-499 copies/mL 2 0 0 0 2
Hepatitis C Infection Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 11 participants 11 participants 45 participants
Positive History 6 3 7 8 24
Negative History 6 8 4 3 21
1.Primary Outcome
Title Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat
Hide Description CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 5 7
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-30.78
(-68.27 to 24.71)
4.16
(-38.76 to 47.95)
-12.17
(-56.98 to 9.81)
-30.56
(-65.78 to 59.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paroxetine and Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.893
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paroxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.594
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Primary Outcome
Title Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol
Hide Description CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 6 2 4
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-51.35
(-119.66 to 5.95)
34.11
(-4.71 to 51.20)
-65.00
(-69.00 to -60.99)
-52.37
(-87.89 to -7.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paroxetine and Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.673
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paroxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.282
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Primary Outcome
Title Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat
Hide Description CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for all participants for whom CSF data are available (intent to treat analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For intention to treat analysis, 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 5 7
Median (Inter-Quartile Range)
Unit of Measure: pi*mm^2
6.392
(-14.214 to 11.674)
12.235
(-23.502 to 30.271)
33.767
(-10.912 to 35.853)
-8.747
(-21.055 to 4.282)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paroxetine and Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.327
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paroxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.178
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Primary Outcome
Title Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol
Hide Description CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for participants with 90% or greater adherence to study drug and for whom CSF data are available (per protocol analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For per protocol analysis, 18 participants (out of the total 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 6 2 4
Median (Inter-Quartile Range)
Unit of Measure: pi*mm^2
0.712
(-17.441 to 10.034)
0.257
(-31.676 to 25.563)
-3.959
(-22.821 to 14.904)
-13.160
(-19.314 to -4.499)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paroxetine and Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paroxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluconazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.672
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
5.Secondary Outcome
Title Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat
Hide Description CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 5 7
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-17.7
(-53.7 to 32.4)
15.2
(-19.1 to 72.3)
-16.5
(-48.5 to -6.1)
12.0
(-53.6 to 21.0)
6.Secondary Outcome
Title Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol
Hide Description CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 6 2 4
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-4.3
(-62.0 to 60.3)
33.2
(-55.1 to 84.7)
-5.1
(-5.6 to -4.5)
-18.9
(-51.8 to 12.0)
7.Secondary Outcome
Title Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat
Hide Description CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 5 7
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
1.6
(-3.2 to 3.5)
-0.7
(-2.4 to 1.1)
-2.7
(-8.1 to 2.6)
-3.8
(-5.1 to 1.4)
8.Secondary Outcome
Title Change in CSF CD163 Between Baseline and Week 24 - Per Protocol
Hide Description CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 6 2 4
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-3.2
(-6.1 to -0.2)
-0.7
(-2.5 to 3.9)
-7.5
(-9.8 to -5.1)
-1.8
(-3.8 to 0.7)
9.Secondary Outcome
Title Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat
Hide Description CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 5 7
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
0.0890
(0.0285 to 0.1855)
0.1710
(0.1043 to 0.2733)
0.2030
(-0.0270 to 0.2170)
0.1000
(-0.0475 to 0.1705)
10.Secondary Outcome
Title Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol
Hide Description CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 6 2 4
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
0.0560
(0.0233 to 0.1180)
0.1580
(-0.0012 to 0.2588)
0.0985
(0.0358 to 0.1613)
0.1375
(0.0528 to 0.2223)
11.Secondary Outcome
Title Change in CSF Neurofilament Protein Heavy Chain (pNFL) Between Baseline and Week 24 - Intent to Treat
Hide Description CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 5 7
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-0.0080
(-0.0275 to 0.0205)
0.0705
(0.0338 to 0.0975)
0.0400
(0.0290 to 0.1280)
0.0520
(0.0345 to 0.0755)
12.Secondary Outcome
Title Change in CSF Neurofilament Protein Heavy Chain (pNFH) Between Baseline and Week 24 - Per Protocol
Hide Description CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFH) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 6 2 4
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-0.0035
(-0.0208 to 0.0303)
0.0645
(0.0133 to 0.0888)
0.0270
(0.0205 to 0.0335)
0.0395
(0.0130 to 0.0618)
13.Secondary Outcome
Title Neurocognitive Performance: Trail Making A - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 9 10 10
Mean (Standard Deviation)
Unit of Measure: Z score
0.045  (0.88) 0.067  (0.98) 0.000  (0.77) 0.09  (0.89)
14.Secondary Outcome
Title Neurocognitive Performance: Trail Making A - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 7 5
Mean (Standard Deviation)
Unit of Measure: Z score
-0.28  (0.96) 0.17  (0.98) 0.24  (0.58) 0.52  (1.01)
15.Secondary Outcome
Title Neurocognitive Performance: Trail Making B - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 9 10 10
Mean (Standard Deviation)
Unit of Measure: Z score
0.47  (0.98) -0.71  (0.93) 0.51  (1.03) 0.020  (0.75)
16.Secondary Outcome
Title Neurocognitive Performance: Trail Making B - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 7 5
Mean (Standard Deviation)
Unit of Measure: Z score
0.63  (0.95) -0.83  (1.48) 0.49  (0.89) 0.16  (0.50)
17.Secondary Outcome
Title Neurocognitive Performance: Grooved Pegboard, Dominant - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 10 10
Mean (Standard Deviation)
Unit of Measure: Z score
0.23  (0.92) 0.05  (1.09) 0.57  (1.05) -0.01  (0.88)
18.Secondary Outcome
Title Neurocognitive Performance: Grooved Pegboard, Dominant - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 7 5
Mean (Standard Deviation)
Unit of Measure: Z score
0.15  (1.10) -0.67  (0.61) 0.59  (1.23) -0.14  (1.07)
19.Secondary Outcome
Title Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 8 10 10
Mean (Standard Deviation)
Unit of Measure: Z score
-0.16  (1.10) -0.11  (0.53) 0.20  (0.85) 0.05  (0.85)
20.Secondary Outcome
Title Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 7 5
Mean (Standard Deviation)
Unit of Measure: Z score
-0.17  (1.39) 0.13  (0.61) 0.41  (0.94) -0.42  (0.84)
21.Secondary Outcome
Title Neurocognitive Performance: CalCAP, Choice - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 10 6 11 8
Mean (Standard Deviation)
Unit of Measure: Z score
0.152  (1.468) -0.570  (1.348) 0.871  (2.771) -1.325  (1.779)
22.Secondary Outcome
Title Neurocognitive Performance: CalCAP, Choice - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 1 8 5
Mean (Standard Deviation)
Unit of Measure: Z score
-0.440  (1.004) -1.17 [1]   (NA) 1.724  (2.711) -0.554  (1.751)
[1]
Mean based on only 1 participant
23.Secondary Outcome
Title Neurocognitive Performance: CalCAP, Sequential - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 10 6 11 8
Mean (Standard Deviation)
Unit of Measure: Z score
0.272  (0.781) -0.025  (0.931) 0.317  (1.534) -0.530  (0.535)
24.Secondary Outcome
Title Neurocognitive Performance: CalCAP, Sequential - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 1 8 5
Mean (Standard Deviation)
Unit of Measure: Z score
0.355  (0.886) -0.11 [1]   (NA) 0.631  (1.464) -0.394  (0.433)
[1]
Mean based on only 1 participant.
25.Secondary Outcome
Title Neurocognitive Performance: Symbol-Digit Test - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available (no data substitution) at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 9 10 10
Mean (Standard Deviation)
Unit of Measure: Z score
0.494  (0.828) 0.175  (1.183) 0.050  (0.901) -0.175  (0.677)
26.Secondary Outcome
Title Neurocognitive Performance: Symbol-Digit Test - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes participants who completed the study per protocol and with test data available (no data substitution) at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 7 5
Mean (Standard Deviation)
Unit of Measure: Z score
0.354  (0.666) -0.167  (1.010) 0.275  (0.975) -0.180  (0.903)
27.Secondary Outcome
Title Neurocognitive Performance: Timed Gait - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 10 7 8 8
Mean (Standard Deviation)
Unit of Measure: Z score
-0.575  (1.038) -0.425  (1.135) 0.283  (0.869) -0.148  (1.127)
28.Secondary Outcome
Title Neurocognitive Performance: Timed Gait - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 5 5
Mean (Standard Deviation)
Unit of Measure: Z score
-0.641  (1.141) -0.170  (1.465) 0.574  (0.833) -0.584  (1.166)
29.Secondary Outcome
Title Neurocognitive Performance: NPZ-8 - Intent to Treat
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 10 10 8 10
Mean (Standard Deviation)
Unit of Measure: Z score
0.121  (0.538) -0.165  (0.590) 0.313  (0.628) -0.191  (0.432)
30.Secondary Outcome
Title Neurocognitive Performance: NPZ-8 - Per Protocol
Hide Description Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 7 5
Mean (Standard Deviation)
Unit of Measure: Z score
-0.005  (0.527) -0.298  (0.290) 0.575  (0.485) -0.199  (0.192)
31.Secondary Outcome
Title Change in CES-D Score - Intent to Treat
Hide Description Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (intent to treat analysis).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 11 9 11 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.182  (6.750) 1.222  (13.321) -1.182  (2.822) 2.600  (8.618)
32.Secondary Outcome
Title Change in CES-D Score - Per Protocol
Hide Description Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (per protocol).
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.
Arm/Group Title Paroxetine and Fluconazole Fluconazole Paroxetine Placebo
Hide Arm/Group Description:

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

Overall Number of Participants Analyzed 6 3 8 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.667  (3.327) 6.000  (16.093) -0.875  (3.182) 8.800  (7.190)
Time Frame Adverse event data were collected during the 24 week clinical trial period for each subject, and if pertinent, during the follow-up period, which was at least 14 days and up to 60 days after discontinuation of the intervention. When applicable, some adverse event data were collected between the screening visit and baseline visit (e.g., safety data pertaining to the lumbar puncture procedure).
Adverse Event Reporting Description Routine safety blood tests were performed at screening, baseline, week 4, week 12, and week 24 visits. A combination of open-ended questioning, medical chart review, and standard questionnaires was used to collect adverse event data at each of the visits. A study clinician performed standard neuro-medical physical exams at baseline, week 12, and week 24. If warranted, data collection occurred between visits, ad hoc, to track ongoing adverse events, as well as after stopping the intervention.
 
Arm/Group Title Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Hide Arm/Group Description

Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day

Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day

Paroxetine: Two 10 MG capsules paroxetine once daily in the evening

Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day

Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing

Placebos in place of fluconazole and paroxetine

Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening

All-Cause Mortality
Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/11 (0.00%)      0/11 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      0/11 (0.00%)      3/11 (27.27%)      3/11 (27.27%)    
Endocrine disorders         
Glucose, non-fasting, high  [1]  0/12 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Gastrointestinal disorders         
Small bowel obstruction   0/12 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Injury, poisoning and procedural complications         
Heroin abuse, relapse   0/12 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1 1/11 (9.09%)  1
Psychiatric disorders         
Depression, acute  [2]  0/12 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Surgical and medical procedures         
Surgery, knee replacement  [3]  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Surgery, neck  [4]  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Grade 4 (DAIDS); hyperglycemia in the context of acute uncontrolled diabetes
[2]
Grade 3 (DAIDS); Acute episode, resolved
[3]
Inpatient elective surgery followed by complications
[4]
Elective surgery to treat cervical stenosis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paroxetine and Fluconazole Paroxetine Fluconazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/12 (91.67%)      10/11 (90.91%)      10/11 (90.91%)      10/11 (90.91%)    
Blood and lymphatic system disorders         
Lymphadenopathy, cervical   0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Cardiac disorders         
Hypertensive episode  [1]  0/12 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1
Endocrine disorders         
Glucose, blood, high  [2]  0/12 (0.00%)  0/11 (0.00%)  3/11 (27.27%)  4 1/11 (9.09%)  1
Eye disorders         
Visual changes   0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Gastrointestinal disorders         
Abdominal cramping or pain  [3]  0/12 (0.00%)  0 1/11 (9.09%)  1 1/11 (9.09%)  1 1/11 (9.09%)  1
Constipation  [4]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Diarrhea  [5]  5/12 (41.67%)  5 1/11 (9.09%)  1 1/11 (9.09%)  1 2/11 (18.18%)  2
Gastroenteritis, foodborne illness  [6]  0/12 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1
Nausea  [4]  4/12 (33.33%)  4 1/11 (9.09%)  1 4/11 (36.36%)  4 1/11 (9.09%)  1
Vomiting  [5]  1/12 (8.33%)  1 1/11 (9.09%)  1 1/11 (9.09%)  1 0/11 (0.00%) 
General disorders         
Agitation   0/12 (0.00%)  0 1/11 (9.09%)  1 1/11 (9.09%)  1 0/11 (0.00%)  0
Altered taste   0/12 (0.00%)  1/11 (9.09%)  1 1/11 (9.09%)  1 0/11 (0.00%) 
Darkening of urine   0/12 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%)  1/11 (9.09%)  1
Dizziness  [7]  2/12 (16.67%)  2 0/11 (0.00%)  0/11 (0.00%)  0/11 (0.00%) 
Dry mouth  [6]  3/12 (25.00%)  3 0/11 (0.00%)  2/11 (18.18%)  2 0/11 (0.00%) 
Fatigue  [5]  1/12 (8.33%)  1 0/11 (0.00%)  0/11 (0.00%)  0/11 (0.00%) 
Flank pain, unilateral  [8]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Glucose, blood, low  [9]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 1/11 (9.09%)  1
Headache, non-specific  [10]  1/12 (8.33%)  1 2/11 (18.18%)  2 1/11 (9.09%)  1 0/11 (0.00%) 
Hypokalemia  [5]  1/12 (8.33%)  2 0/11 (0.00%)  0/11 (0.00%)  0/11 (0.00%) 
Incontinence, acute nocturnal  [11]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Insomnia   0/12 (0.00%)  2/11 (18.18%)  2 1/11 (9.09%)  1 0/11 (0.00%) 
Lightheadedness   1/12 (8.33%)  1 0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Nose bleed  [11]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Polyuria  [11]  1/12 (8.33%)  1 0/11 (0.00%)  0/11 (0.00%)  0/11 (0.00%) 
Psychotropic effects, non-specific   0/12 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%)  0/11 (0.00%) 
Tinnitus, bilateral   0/12 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%)  0/11 (0.00%) 
Vivid or disturbing dreams   0/12 (0.00%)  2/11 (18.18%)  2 0/11 (0.00%)  0/11 (0.00%) 
Weight loss  [5]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Hepatobiliary disorders         
Alanine aminotransferase (ALT), high  [12]  0/12 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%)  1/11 (9.09%)  1
Aspartate aminotransferase (AST), high  [12]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Alkaline phosphatase, high  [12]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Bilirubin, total, high  [13]  0/12 (0.00%)  2/11 (18.18%)  5 3/11 (27.27%)  4 1/11 (9.09%)  1
Creatinine, blood, high  [12]  0/12 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  3
Immune system disorders         
Absolute neutrophil count (ANC), low  [12]  0/12 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  2
Infections and infestations         
Chlamydia, new infection/exposure  [14]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Lymph node infection, neck  [14]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Syphilis, new infection/exposure  [14]  1/12 (8.33%)  1 0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Tooth infection  [14]  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Upper respiratory infection   0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/11 (0.00%) 
Injury, poisoning and procedural complications         
Automobile accident  [15]  0/12 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%)  0/11 (0.00%) 
Sprain, ankle   0/12 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/11 (0.00%) 
Metabolism and nutrition disorders         
Blood urea nitrogen (BUN), high  [16]  3/12 (25.00%)  5 0/11 (0.00%)  1/11 (9.09%)  3 3/11 (27.27%)  6
Blood urea nitrogen (BUN), low  [17]  1/12 (8.33%)  1 0/11 (0.00%)  1/11 (9.09%)  1 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders         
Back pain, generalized   1/12 (8.33%)  1 1/11 (9.09%)  1 0/11 (0.00%)  0/11 (0.00%) 
Joint pain, generalized   0/12 (0.00%)  1/11 (9.09%)  1 1/11 (9.09%)  1 0/11 (0.00%) 
Joint pain, hip, unilateral   0/12 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%)  0/11 (0.00%) 
Joint pain, shoulder, unilateral   0/12 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%)  0/11 (0.00%) 
Nervous system disorders         
Headache, post-lumbar puncture  [18]  1/12 (8.33%)  1 0/11 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1
Psychiatric disorders         
Depressed mood  [6]  0/12 (0.00%)  0/11 (0.00%)  2/11 (18.18%)  2 0/11 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis (kidney stone)   1/12 (8.33%)  1 1/11 (9.09%)  1 0/11 (0.00%)  0 1/11 (9.09%)  1
Prostitis   0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Urinary hesitancy   1/12 (8.33%)  1 0/11 (0.00%)  0/11 (0.00%)  0/11 (0.00%) 
Reproductive system and breast disorders         
Sexual dysfunction   0/12 (0.00%)  4/11 (36.36%)  4 1/11 (9.09%)  1 0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute bronchospasm  [19]  0/12 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  2
Skin and subcutaneous tissue disorders         
Alopecia   2/12 (16.67%)  2 0/11 (0.00%)  1/11 (9.09%)  1 1/11 (9.09%)  1
Cyst, subcutaneous   0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1 0/11 (0.00%) 
Rash   1/12 (8.33%)  1 1/11 (9.09%)  1 1/11 (9.09%)  1 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Grade 3 (DAIDS); context of diagnosed/treated hypertension, participant had not taken morning medications
[2]
Blood test, non-fasting, grade 2 or 3 (DAIDS 2.0)
[3]
Generalized abdominal cramping or pain (non-focalized)
[4]
Grade 2 or 3 (DAIDS 2.0)
[5]
Grade 2 (DAIDS 2.0)
[6]
Self-reported
[7]
Self-reported, intermittent
[8]
Non-specific, self-limited
[9]
Blood test, non-fasting, grade 2 (DAIDS 2.0)
[10]
Intermittent, grade 2 (DAIDS 2.0)
[11]
Self-limited
[12]
Blood test, grade 2 (DAIDS 2.0)
[13]
Blood test, grade 2 or 3 (DAIDS 2.0)
[14]
Treated for infection
[15]
Passenger, visit to ED, back injury, discharged home
[16]
Blood test, range: 23-41 mg/dL
[17]
Blood test, range: 5-6 mg/dL
[18]
Post-LP postural headache requiring follow-up care
[19]
Grade 2 (DAIDS 2.0); context of chronic obstructive pulmonary disease requiring visit to emergency department
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ned Sacktor
Organization: The Johns Hopkins University
Phone: 410-550-1045
Responsible Party: Ned Sacktor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01354314     History of Changes
Other Study ID Numbers: NA_00037283
P30MH075673-05 ( U.S. NIH Grant/Contract )
First Submitted: May 13, 2011
First Posted: May 16, 2011
Results First Submitted: April 3, 2017
Results First Posted: May 12, 2017
Last Update Posted: June 9, 2017