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High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00885703
Recruitment Status : Completed
First Posted : April 22, 2009
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cryptococcal Meningitis
HIV Infections
Interventions: Drug: Fluconazole
Drug: Amphotericin B

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened on February 19, 2010. The first participant enrolled on April 16, 2010. Stage 1 closed on September 5, 2013. A5225 Stage 2 opened on September 15, 2014 and the first participant enrolled on February 2, 2015. Stage 2 closed on August 19, 2016. Ten sites enrolled participants (1 domestic, 9 international).

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
Stage 1, Fluconazole 1200mg

Participants receive Fluconazole 1200mg induction dose in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 1, Fluconazole 1600mg

Participants receive Fluconazole 1600mg induction dose in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 1, Fluconazole 2000mg

Participants receive Fluconazole 2000mg induction dose in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 1, Ampho B

Participants receive Amphotericin B followed by Fluconazole in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight

Stage 2, Fluconazole 1600mg

Participants receive Fluconazole 1600mg induction dose in Stage 2

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 2, Fulconazole 2000mg

Participants receive Fluconazole 2000mg induction dose in Stage 2

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 2, Ampho B

Participants receive Amphotericin B followed by Fluconazole in Stage 2

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight


Participant Flow:   Overall Study
    Stage 1, Fluconazole 1200mg   Stage 1, Fluconazole 1600mg   Stage 1, Fluconazole 2000mg   Stage 1, Ampho B   Stage 2, Fluconazole 1600mg   Stage 2, Fulconazole 2000mg   Stage 2, Ampho B
STARTED   22   26   24   24   24   24   24 
COMPLETED   12   16   13   15   12   11   18 
NOT COMPLETED   10   10   11   9   12   13   6 
Death                9                7                8                7                7                8                4 
Lost to Follow-up                0                0                1                0                0                1                0 
Withdrawal by Subject                0                0                0                1                3                1                1 
Ineligible (no CM)                1                3                2                1                2                3                1 



  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
Stage 1, Fluconazole 1200mg

Participants receive Fluconazole 1200mg induction dose in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 1, Fluconazole 1600mg

Participants receive Fluconazole 1600mg induction dose in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 1, Fluconazole 2000mg

Participants receive Fluconazole 2000mg induction dose in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 1, Ampho B

Participants receive Amphotericin B followed by Fluconazole in Stage 1

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight

Stage 2, Fluconazole 1600mg

Participants receive Fluconazole 1600mg induction dose in Stage 2

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 2, Fluconazole 2000mg

Participants receive Fluconazole 2000mg induction dose in Stage 2

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Stage 2, Ampho B

Participants receive Amphotericin B followed by Fluconazole in Stage 2

Fluconazole: Step 1: [For participants randomized to Fluconazole] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).

Step 2: [For participants randomized to Ampho B only] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.

Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.

Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.

Amphotericin B: Step 1: [For participants randomized to Ampho B] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight

Total Total of all reporting groups

Baseline Measures
   Stage 1, Fluconazole 1200mg   Stage 1, Fluconazole 1600mg   Stage 1, Fluconazole 2000mg   Stage 1, Ampho B   Stage 2, Fluconazole 1600mg   Stage 2, Fluconazole 2000mg   Stage 2, Ampho B   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Age 
[Units: Years]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
   40.5 
 (36 to 47) 
 33 
 (28 to 39) 
 38 
 (31 to 48) 
 35.5 
 (30 to 41) 
 32.5 
 (29.5 to 35.5) 
 33.5 
 (29 to 38) 
 37.5 
 (34 to 40) 
 36 
 (30 to 41) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Female      10  45.5%      14  53.8%      14  58.3%      11  45.8%      10  41.7%      10  41.7%      9  37.5%      78  46.4% 
Male      12  54.5%      12  46.2%      10  41.7%      13  54.2%      14  58.3%      14  58.3%      15  62.5%      90  53.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
               
Black Non-Hispanic                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Black Non-Hispanic   12   21   22   19   24   22   23   143 
Hispanic (regardless of Race)                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Hispanic (regardless of Race)   0   4   2   1   0   2   1   10 
Asian, Pacific Islander                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Asian, Pacific Islander   10   1   0   4   0   0   0   15 
Region of Enrollment 
[Units: Participants]
               
United States                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
United States   1   0   2   1   0   0   0   4 
South Africa                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
South Africa   1   6   3   5   2   3   6   26 
Uganda                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Uganda   0   2   11   5   14   13   12   57 
Zimbabwe                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Zimbabwe   2   4   1   3   4   1   3   18 
Kenya                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Kenya   8   9   7   6   4   6   2   42 
Thailand                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Thailand   5   0   0   1   0   0   0   6 
Peru                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
Peru   0   4   0   0   0   1   1   6 
India                 
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
India   5   1   0   3   0   0   0   9 
Weight 
[Units: Kilograms]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
   46.5 
 (42.0 to 52.2) 
 50.5 
 (44.0 to 65.0) 
 51.9 
 (43.5 to 58.5) 
 56.8 
 (47.5 to 64.1) 
 49.8 
 (44.5 to 60.0) 
 55.0 
 (51.6 to 59.1) 
 52.5 
 (48.5 to 60.1) 
 52.0 
 (44.7 to 59.3) 
BMI (Body Mass Index) 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
   17.2 
 (15.6 to 19.6) 
 19.6 
 (17.3 to 21.8) 
 18.3 
 (17.2 to 22.7) 
 19.8 
 (16.3 to 24.3) 
 18.7 
 (17.1 to 20.3) 
 19.8 
 (18.6 to 22.5) 
 19.6 
 (17.5 to 22.9) 
 18.9 
 (16.9 to 21.9) 
CD4+ 
[Units: Participants]
Count of Participants
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
< 50 cells/mm^3      15  68.2%      10  38.5%      17  70.8%      17  70.8%      20  83.3%      16  66.7%      17  70.8%      112  66.7% 
50 - <100 cells/mm^3      6  27.3%      9  34.6%      4  16.7%      4  16.7%      3  12.5%      5  20.8%      5  20.8%      36  21.4% 
100 - <200 cells/mm^3      1   4.5%      4  15.4%      3  12.5%      2   8.3%      0   0.0%      3  12.5%      2   8.3%      15   8.9% 
200+ cells/mm^3      0   0.0%      3  11.5%      0   0.0%      1   4.2%      1   4.2%      0   0.0%      0   0.0%      5   3.0% 
HIV-1 RNA 
[Units: log10(copies/mL)]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
   5.3 
 (5.1 to 6.0) 
 5.6 
 (5.1 to 5.8) 
 5.5 
 (5.2 to 5.9) 
 5.4 
 (5.2 to 5.7) 
 5.2 
 (4.9 to 5.5) 
 4.9 
 (2.8 to 5.4) 
 4.6 
 (3.5 to 5.5) 
 5.3 
 (4.7 to 5.7) 
Glasgow Coma Score [1] [2] 
[Units: Participants]
Count of Participants
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   23   24   167 
GCS <15      5  22.7%      3  11.5%      5  20.8%      1   4.2%      2   8.3%      0   0.0%      0   0.0%      16   9.6% 
GCS =15      17  77.3%      23  88.5%      19  79.2%      23  95.8%      22  91.7%      23 100.0%      24 100.0%      151  90.4% 
[1] The Glasgow Coma Score provides an assessment of impairment of conscious level in response to defined stimuli. The GCS is on a scale from 0=worst to 15=best.
[2] One participant missing baseline Glasgow Coma Score.
Quantitative Cryptococcal Meningitis Culture 
[Units: Log10 CFU/mL]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
   5.18 
 (4.23 to 6.02) 
 4.45 
 (3.98 to 5.09) 
 5.15 
 (4.25 to 5.80) 
 4.37 
 (3.33 to 5.23) 
 5.34 
 (4.31 to 5.47) 
 4.29 
 (2.05 to 5.32) 
 5.14 
 (3.40 to 5.42) 
 5.04 
 (3.80 to 5.42) 
Anti-Retroviral Therapy (ART) Status 
[Units: Participants]
Count of Participants
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
On ART      0   0.0%      0   0.0%      0   0.0%      0   0.0%      8  33.3%      12  50.0%      11  45.8%      31  18.5% 
Not on ART      22 100.0%      26 100.0%      24 100.0%      24 100.0%      16  66.7%      12  50.0%      13  54.2%      137  81.5% 
Opportunistic Infections 
[Units: Participants]
Count of Participants
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
One or more opportunistic infections      10  45.5%      7  26.9%      11  45.8%      10  41.7%      11  45.8%      9  37.5%      10  41.7%      68  40.5% 
No opportunistic infections      12  54.5%      19  73.1%      13  54.2%      14  58.3%      13  54.2%      15  62.5%      14  58.3%      100  59.5% 
Mini Mental Status [1] [2] 
[Units: Scores on a scale]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 19   25   21   22   23   24   24   158 
   26 
 (23 to 26) 
 25 
 (23 to 26) 
 26 
 (22 to 26) 
 26 
 (24 to 26) 
 26 
 (21 to 26) 
 26 
 (19 to 26) 
 25.5 
 (20 to 26) 
 26 
 (22 to 26) 
[1] The Mini Mental Status is a 26-point questionnaire that is used to measure cognitive impairment. Scale is 0=worst to 26=best.
[2] Not all participants were able to complete a Mini Mental Status at baseline.
Opening Pressure (from Lumbar Pucture) [1] 
[Units: Mm H20]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 21   26   23   23   24   24   24   165 
   200 
 (105 to 300) 
 200 
 (150 to 290) 
 350 
 (180 to 550) 
 190 
 (120 to 300) 
 200 
 (150 to 254) 
 190 
 (120 to 235) 
 303 
 (250 to 485) 
 210 
 (141 to 320) 
[1] Not all participants were able to have a lumbar puncture at entry.
White Blood Cell count (from CSF) [1] 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 19   21   23   21   23   23   23   153 
   80 
 (30 to 500) 
 30 
 (4 to 100) 
 17 
 (9 to 310) 
 26 
 (15 to 133) 
 19 
 (8 to 33) 
 16 
 (12 to 89) 
 13 
 (8 to 53) 
 19 
 (9 to 100) 
[1] Not all participants were able to have a lumbar puncture. Of those that did, not all were able to have enough fluid collected for WBC count.
Albumin [1] 
[Units: g/dL]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   23   24   167 
   3.0 
 (2.6 to 3.3) 
 3.2 
 (3.1 to 3.6) 
 3.3 
 (2.9 to 3.6) 
 3.2 
 (2.8 to 3.6) 
 3.1 
 (2.8 to 3.2) 
 3.1 
 (2.7 to 3.6) 
 3.1 
 (2.7 to 3.6) 
 3.2 
 (2.8 to 3.5) 
[1] Not all participants had an albumin measurement.
ALT (Alanine Aminotransferase) 
[Units: U/L]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
   15.7 
 (11.0 to 22.8) 
 19.0 
 (13.0 to 29.2) 
 24.7 
 (14.0 to 41.8) 
 21.5 
 (11.7 to 32.7) 
 25.2 
 (17.4 to 38.0) 
 24.1 
 (14.5 to 32.1) 
 18.1 
 (14.5 to 35.3) 
 20.6 
 (14.0 to 32.6) 
Creatinine Clearance 
[Units: mL/min]
Mean (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   26   24   24   24   24   24   168 
   94.2 
 (79.5 to 112.1) 
 94.5 
 (79.3 to 106.3) 
 94.2 
 (72.7 to 115.2) 
 102.3 
 (81.9 to 135.5) 
 94.0 
 (68.2 to 104.0) 
 98.8 
 (67.3 to 121.8) 
 94.4 
 (77.6 to 113.5) 
 95.0 
 (75.0 to 113.3) 
Cryptococcal Antigen (CrAG) Titer [1] 
[Units: Titers]
Median (Inter-Quartile Range)
               
Participants Analyzed 
[Units: Participants]
 22   23   22   23   23   23   22   158 
   756 
 (256 to 8192) 
 128 
 (32 to 1024) 
 815.5 
 (125 to 8192) 
 1050 
 (160 to 4096) 
 256 
 (20 to 1024) 
 128 
 (16 to 2048) 
 416 
 (128 to 4096) 
 452.5 
 (32 to 2405) 
[1] Not all participants had a CrAG titer observed at baseline.


  Outcome Measures

1.  Primary:   Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B   [ Time Frame: Measured from study entry through Week10 ]

2.  Primary:   Categorized Quantitative Culture Results   [ Time Frame: At entry, Week 2, and Week 10 ]

3.  Primary:   Change in Log10 Quantitative CSF Culture Results   [ Time Frame: Entry and Week 2 ]

4.  Primary:   Kaplan Meier (KM) Proportion of Participant Mortality   [ Time Frame: Measured from study entry through Week 24 ]

5.  Secondary:   Results of the Neurological Examination   [ Time Frame: Measured at study entry, Week 2, and Week 10 ]

6.  Secondary:   Results of Functional Status Evaluation   [ Time Frame: Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24 ]

7.  Secondary:   Length of Hospitalization   [ Time Frame: Measured from study entry through Week 10 ]

8.  Secondary:   Number of Hospital Admissions   [ Time Frame: Measured from study entry through Week 24 ]

9.  Secondary:   Number of Participants With Progression of Symptoms   [ Time Frame: Measured from study entry through Week 24 ]

10.  Secondary:   Number of Participants With CNS IRIS   [ Time Frame: Measured from study entry through Week 24 ]

11.  Secondary:   Number of Participants With Grade 3 and 4 Adverse Events   [ Time Frame: Measured from study entry through Week 24 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00885703     History of Changes
Other Study ID Numbers: A5225 (HiFLAC)
10149 ( Registry Identifier: DAIDS-ES )
ACTG A5225
HiFLAC
A5225/HiFLAC
A5225
First Submitted: April 20, 2009
First Posted: April 22, 2009
Results First Submitted: January 11, 2018
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018