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Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects

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ClinicalTrials.gov Identifier: NCT00991289
Recruitment Status : Completed
First Posted : October 8, 2009
Results First Posted : September 27, 2011
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infection
Hepatitis C Infection
Interventions Drug: Nitazoxanide (NTZ)
Drug: Pegylated interferon alfa-2a (PEG)
Drug: Ribavirin (RBV)
Enrollment 68
Recruitment Details Men and women at least 18 years of age with genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection and naive to previous HCV treatment were recruited for participation in this study.
Pre-assignment Details  
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Period Title: Overall Study
Started 67 [1]
COMPLETED Week 16 61 [2]
Completed 55 [3]
Not Completed 12
Reason Not Completed
Adverse Event             1
Physician Decision             2
Withdrawal by Subject             3
Lost to Follow-up             4
Protocol Violation             2
[1]
68 participants enrolled, one was found to have been ineligible and was excluded.
[2]
Completed 16 weeks of the study (the primary endpoint time point). The study continued to Week 76.
[3]
Completed study.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Baseline Participants 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants
48.1  (8.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants
<25 years 1
25 to <30 years 1
30 to <35 years 4
35 to <40 years 3
40 to <45 years 11
45 to <50 years 13
50 to <55 years 18
55 to 60 years 13
>=60 years 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Female
15
  22.4%
Male
52
  77.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants
White, Non-Hispanic 21
Black, Non-Hispanic 32
Hispanic, Regardless of Race 12
Other/Unknown 2
[1]
Measure Description: Race/ethnicity, self-reported (NIH categories)
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants
67
HCV viral load level   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Log10 IU/ml
Number Analyzed 67 participants
6.4
(6.0 to 6.7)
[1]
Measure Description: Hepatitis C virus (HCV) viral load testing was done using Cobas AmpliPrep/Taqman HCV Test with lower limit of quantitation of 43 IU/ml.
CD4+ T cell count  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm3
Number Analyzed 67 participants
452
(323 to 738)
Number of participants with indicated HIV viral load   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants
Undetectable HIV viral load 49
Detectable HIV viral load 16
Unknown 2
[1]
Measure Description: A blood sample was drawn to determine the HIV viral load by local laboratories. HIV viral load was categorized as <lower limit of quantification (undetectable) of the assay or >=lower limit of quantification of the assay (detectable). The assays used were bDNA assay (Versant HIV-1 RNA 3.0), Roche COBAS AmpliPrp/Taqman HIV-1 assay and Abbott RealTime HIV-1 assay.
HIV Antiretroviral therapy (ART) status  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 67 participants
On ART 61
Not on ART 6
1.Primary Outcome
Title Percentage of Participants With Complete Early Virologic Response (cEVR)
Hide Description Complete early virologic response (cEVR) was defined as undetectable HCV viral load (<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
38.8
(28.8 to 49.6)
2.Primary Outcome
Title Percentage of Participants With Early Virologic Response (EVR)
Hide Description Early virologic response (EVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Time Frame Weeks 0, 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
65.7
(55.0 to 75.3)
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR)
Hide Description Sustained virologic response (SVR) was defined as undetectable HCV viral load (<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders.
Time Frame 24 weeks after treatment discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled, except one who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without HCV RNA from 24 weeks after treatment discontinuation, non-EVRs and those with detectable HCV RNA at Week 28, were considered non-responders.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
32.8
(23.4 to 43.5)
4.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR)
Hide Description Rapid virologic response (RVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 8 HCV viral load result were considered non-responders.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
10.4
(5.0 to 18.7)
5.Secondary Outcome
Title Number of Participants With Adverse Events of Grade 2 or Higher
Hide Description Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Time Frame From study entry to up to week 76
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled, except one participant who was found to have been ineligible after entry.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: participants
65
6.Secondary Outcome
Title Change in Hemoglobin Level From Study Entry
Hide Description Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry.
Time Frame Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled (except one participant who was found to have been ineligible after entry) and had HGB measurements available at entry and at the respective post-entry time point.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Median (Inter-Quartile Range)
Unit of Measure: g/dL
Change in HGB at Week 4 Number Analyzed 65 participants
-0.1
(-0.6 to 0.4)
Change in HGB at Week 8 Number Analyzed 65 participants
-2.1
(-3.0 to -1.1)
Change in HGB at Week 12 Number Analyzed 63 participants
-2.5
(-3.5 to -1.8)
Change in HGB at Week 16 Number Analyzed 60 participants
-2.5
(-3.5 to -1.4)
Change in HGB at Week 20 Number Analyzed 55 participants
-2.5
(-3.8 to -1.3)
Change in HGB at Week 24 Number Analyzed 51 participants
-2.4
(-3.2 to -1.3)
Change in HGB at Week 28 Number Analyzed 45 participants
-2.5
(-3.4 to -1.6)
Change in HGB at Week 32 Number Analyzed 38 participants
-2.7
(-3.4 to -1.7)
Change in HGB at Week 36 Number Analyzed 39 participants
-2.5
(-3.9 to -1.7)
Change in HGB at Week 40 Number Analyzed 40 participants
-2.6
(-3.4 to -2.1)
Change in HGB at Week 44 Number Analyzed 31 participants
-2.6
(-3.9 to -1.6)
Change in HGB at Week 48 Number Analyzed 32 participants
-2.7
(-3.4 to -1.9)
Change in HGB at Week 52 Number Analyzed 31 participants
-2.9
(-3.8 to -1.6)
Change in HGB at Week 76 Number Analyzed 29 participants
-0.9
(-1.3 to -0.5)
7.Secondary Outcome
Title Percent Change in Fasting Insulin Level From Study Entry
Hide Description Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing.
Time Frame Weeks 0, 16, 28, 52, and 76
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled (except one participant who was found to have been ineligible after entry) and had FINS measurements available at entry and the respective post-entry time point.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Median (Inter-Quartile Range)
Unit of Measure: percentage of FINS at study entry
Percent change in FINS at Week 16 Number Analyzed 58 participants
0
(-30.8 to 64.7)
Percent change in FINS at Week 28 Number Analyzed 40 participants
8.8
(-33.2 to 67.9)
Percent change in FINS at Week 52 Number Analyzed 28 participants
28.2
(-15.0 to 87.5)
Percent change in FINS at Week 76 Number Analyzed 23 participants
8.3
(-48.0 to 56.3)
8.Secondary Outcome
Title Percent Change in Fasting Glucose Level From Study Entry
Hide Description Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing.
Time Frame Weeks 0, 16, 28, 52, and 76
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled (except one participant who was found to have been ineligible after entry) and had FGLUC measurements available at entry and the respective post-entry time point.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Median (Inter-Quartile Range)
Unit of Measure: percentage of FGLUC at study entry
Percent change in FGLUC at Week 16 Number Analyzed 58 participants
-3.2
(-12.6 to 7.0)
Percent change in FGLUC at Week 28 Number Analyzed 41 participants
-5.3
(-9.9 to 4.9)
Percent change in FGLUC at Week 52 Number Analyzed 29 participants
1.1
(-11.8 to 8.0)
Percent change in FGLUC at Week 76 Number Analyzed 24 participants
0
(-7.4 to 8.4)
9.Secondary Outcome
Title Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry
Hide Description HOMA-IR was calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.
Time Frame Weeks 0, 16, 28, 52, and 76
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled (except one participant who was found to have been ineligible after entry) and had fasting insulin and fasting glucose measurements available at entry and the respective post-entry time point.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Median (Inter-Quartile Range)
Unit of Measure: percentage of HOMA-IR at study entry
Percent change in HOMA-IR at Week 16 (n=56) Number Analyzed 56 participants
-13.0
(-31.6 to 64.2)
Percent change in HOMA-IR at Week 28 (n=39) Number Analyzed 39 participants
-6.3
(-42.7 to 81.1)
Percent change in HOMA-IR at Week 52 (n=27) Number Analyzed 27 participants
23.2
(-24.2 to 87.1)
Percent change in HOMA-IR at Week 76 (n=22) Number Analyzed 22 participants
9.5
(-48.0 to 59.5)
10.Secondary Outcome
Title Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.
Hide Description Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test.
Time Frame Weeks 0, 4
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HCV viral load measurements available at entry and at Week 4 were analyzed.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 64
Median (Inter-Quartile Range)
Unit of Measure: log10 IU/mL
-0.12
(-0.30 to 0.13)
11.Secondary Outcome
Title Number of Participants With HCV Genotype 1
Hide Description Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY).
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who enrolled, except one participant who was found to have been ineligible after entry.
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description:
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: participants
67
Time Frame From study entry to Week 76.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NTZ/PEG/RBV
Hide Arm/Group Description Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
All-Cause Mortality
NTZ/PEG/RBV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NTZ/PEG/RBV
Affected / at Risk (%)
Total   13/67 (19.40%) 
Blood and lymphatic system disorders   
Anaemia  1  2/67 (2.99%) 
Neutropenia  1  3/67 (4.48%) 
Gastrointestinal disorders   
Abdominal pain  1  2/67 (2.99%) 
Diarrhoea  1  1/67 (1.49%) 
Haematemesis  1  1/67 (1.49%) 
Vomiting  1  1/67 (1.49%) 
General disorders   
Pyrexia  1  1/67 (1.49%) 
Infections and infestations   
Cellulitis  1  1/67 (1.49%) 
Pneumonia  1  3/67 (4.48%) 
Urosepsis  1  1/67 (1.49%) 
Injury, poisoning and procedural complications   
Joint injury  1  1/67 (1.49%) 
Investigations   
Blood creatine phosphokinase increased  1  1/67 (1.49%) 
Nervous system disorders   
Syncope  1  1/67 (1.49%) 
Renal and urinary disorders   
Haematuria  1  1/67 (1.49%) 
Renal failure acute  1  1/67 (1.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NTZ/PEG/RBV
Affected / at Risk (%)
Total   67/67 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  12/67 (17.91%) 
Neutropenia  1  16/67 (23.88%) 
Gastrointestinal disorders   
Abdominal pain  1  7/67 (10.45%) 
Constipation  1  4/67 (5.97%) 
Diarrhoea  1  18/67 (26.87%) 
Dysphagia  1  4/67 (5.97%) 
Nausea  1  13/67 (19.40%) 
Vomiting  1  6/67 (8.96%) 
General disorders   
Fatigue  1  23/67 (34.33%) 
Irritability  1  4/67 (5.97%) 
Pain  1  5/67 (7.46%) 
Pyrexia  1  5/67 (7.46%) 
Infections and infestations   
Pneumonia bacterial  1  4/67 (5.97%) 
Investigations   
Alanine aminotransferase increased  1  36/67 (53.73%) 
Aspartate aminotransferase increased  1  29/67 (43.28%) 
Blood albumin abnormal  1  7/67 (10.45%) 
Blood alkaline phosphatase increased  1  6/67 (8.96%) 
Blood bicarbonate abnormal  1  5/67 (7.46%) 
Blood bilirubin increased  1  14/67 (20.90%) 
Blood glucose abnormal  1  11/67 (16.42%) 
Blood glucose increased  1  6/67 (8.96%) 
Blood phosphorus decreased  1  14/67 (20.90%) 
Blood potassium decreased  1  6/67 (8.96%) 
Blood sodium decreased  1  9/67 (13.43%) 
Blood triglycerides abnormal  1  4/67 (5.97%) 
Blood uric acid increased  1  11/67 (16.42%) 
Haemoglobin decreased  1  24/67 (35.82%) 
Lipase increased  1  11/67 (16.42%) 
Neutrophil count decreased  1  54/67 (80.60%) 
Platelet count decreased  1  35/67 (52.24%) 
Weight decreased  1  21/67 (31.34%) 
White blood cell count decreased  1  23/67 (34.33%) 
Metabolism and nutrition disorders   
Decreased appetite  1  14/67 (20.90%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  5/67 (7.46%) 
Back pain  1  5/67 (7.46%) 
Pain in extremity  1  5/67 (7.46%) 
Nervous system disorders   
Dizziness  1  9/67 (13.43%) 
Headache  1  7/67 (10.45%) 
Psychiatric disorders   
Anxiety  1  5/67 (7.46%) 
Depression  1  9/67 (13.43%) 
Insomnia  1  5/67 (7.46%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/67 (7.46%) 
Dyspnoea  1  7/67 (10.45%) 
Oropharyngeal pain  1  4/67 (5.97%) 
Respiratory tract congestion  1  4/67 (5.97%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  4/67 (5.97%) 
Pruritus  1  4/67 (5.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00991289     History of Changes
Other Study ID Numbers: A5269
10764 ( Registry Identifier: DAIDS ES )
ACTG A5269 ( Other Identifier: ACTG )
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: August 29, 2011
Results First Posted: September 27, 2011
Last Update Posted: February 15, 2019