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

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

Participant Flow

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Recruitment Details
Pre-assignment Details

Arm/Group Title	Paroxetine and Fluconazole	Paroxetine	Fluconazole	Placebo
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.

Baseline Characteristics

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Arm/Group Title		Paroxetine and Fluconazole	Paroxetine	Fluconazole	Placebo	Total
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
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

Outcome Measures

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1. Primary Outcome

Title	Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat
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

Outcome Measure Data

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
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)

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]

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]

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
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

Outcome Measure Data

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
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)

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]

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]

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
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

Outcome Measure Data

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
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)

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]

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]

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
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

Outcome Measure Data

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
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)

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]

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]

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).
Time Frame	24 Weeks

Outcome Measure Data

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
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
Description	Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).
Time Frame	24 Weeks

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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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
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%)
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
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

Limitations and Caveats

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[Not Specified]

More Information

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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

EMail: sacktor@jhmi.edu

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