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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paroxetine and Fluconazole

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

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

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
Placebo

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

Participant Flow:   Overall Study
    Paroxetine and Fluconazole   Paroxetine   Fluconazole   Placebo
STARTED   12   11   11   11 
Completed (ITT) [1]   11   11   9   10 
COMPLETED [2]   6   8   3   5 
NOT COMPLETED   6   3   8   6 
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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paroxetine and Fluconazole

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

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

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
Placebo

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 Total of all reporting groups

Baseline Measures
   Paroxetine and Fluconazole   Paroxetine   Fluconazole   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 12   11   11   11   45 
Age 
[Units: Years]
Mean (Standard Deviation) 		 49.83  (5.77)   52.00  (6.62)   51.73  (5.76)   48.73  (10.23)   50.56  (7.17) 
Age, Customized 
[Units: Years]
 		         
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 
[Units: 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Years Completed]
Mean (Standard Deviation) 		 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] 
[Units: Years]
Mean (Standard Deviation) 		 15.33  (6.77)   16.36  (7.90)   15.45  (6.76)   17.36  (7.93)   16.11  (7.14) 
[1] Based on self-report from participants.
Absolute CD4 Count 
[Units: Cells per cubic mm]
Mean (Standard Deviation) 		 516.1  (244.8)   637.3  (241.7)   555.2  (282.8)   510.4  (235.1)   553.9  (248.2) 
Plasma HIV Viral Load 
[Units: 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 
[Units: Participants]
 		         
Positive History   6   3   7   8   24 
Negative History   6   8   4   3   21 


  Outcome Measures

1.  Primary:   Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 1

2.  Primary:   Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 2

3.  Primary:   Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 3

4.  Primary:   Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change in CSF CD163 Between Baseline and Week 24 - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change in CSF Neurofilament Protein Heavy Chain (pNFL) Between Baseline and Week 24 - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change in CSF Neurofilament Protein Heavy Chain (pNFH) Between Baseline and Week 24 - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 12

13.  Secondary:   Neurocognitive Performance: Trail Making A - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 13

14.  Secondary:   Neurocognitive Performance: Trail Making A - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 14

15.  Secondary:   Neurocognitive Performance: Trail Making B - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 15

16.  Secondary:   Neurocognitive Performance: Trail Making B - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 16

17.  Secondary:   Neurocognitive Performance: Grooved Pegboard, Dominant - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 17

18.  Secondary:   Neurocognitive Performance: Grooved Pegboard, Dominant - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 18

19.  Secondary:   Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 19

20.  Secondary:   Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 20

21.  Secondary:   Neurocognitive Performance: CalCAP, Choice - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 21

22.  Secondary:   Neurocognitive Performance: CalCAP, Choice - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 22

23.  Secondary:   Neurocognitive Performance: CalCAP, Sequential - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 23

24.  Secondary:   Neurocognitive Performance: CalCAP, Sequential - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 24

25.  Secondary:   Neurocognitive Performance: Symbol-Digit Test - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 25

26.  Secondary:   Neurocognitive Performance: Symbol-Digit Test - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 26

27.  Secondary:   Neurocognitive Performance: Timed Gait - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 27

28.  Secondary:   Neurocognitive Performance: Timed Gait - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 28

29.  Secondary:   Neurocognitive Performance: NPZ-8 - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 29

30.  Secondary:   Neurocognitive Performance: NPZ-8 - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 30

31.  Secondary:   Change in CES-D Score - Intent to Treat   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 31

32.  Secondary:   Change in CES-D Score - Per Protocol   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 32


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: 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