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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00991289

First received: October 7, 2009

Last updated: July 6, 2016

Last verified: July 2016

History of Changes

Results First Received: August 29, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	HIV Infection Hepatitis C Infection
Interventions:	Drug: Nitazoxanide (NTZ) Drug: Pegylated interferon alfa-2a (PEG) Drug: Ribavirin (RBV)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
NTZ/PEG/RBV	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.

Participant Flow: Overall Study

	NTZ/PEG/RBV
STARTED	67 ^[1]
COMPLETED Week 16	61 ^[2]
COMPLETED	55 ^[3]
NOT COMPLETED	12
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.

Baseline Characteristics

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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.
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Reporting Groups

	Description
NTZ/PEG/RBV	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.

Baseline Measures

	NTZ/PEG/RBV
Number of Participants [units: participants]	67
Age [units: years] Mean (Standard Deviation)	48.1 (8.5)
Age, Customized [units: 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
Gender [units: participants]
Female	15
Male	52
Race/Ethnicity, Customized ^[1] [units: Participants]
White, Non-Hispanic	21
Black, Non-Hispanic	32
Hispanic, Regardless of Race	12
Other/Unknown	2
Region of Enrollment [units: participants]
United States	67
HCV viral load level ^[2] [units: log10 IU/ml] Median (Inter-Quartile Range)	6.4 (6.0 to 6.7)
CD4+ T cell count [units: cells/mm3] Median (Inter-Quartile Range)	452 (323 to 738)
Number of participants with indicated HIV viral load ^[3] [units: participant]
Undetectable HIV viral load	49
Detectable HIV viral load	16
Unknown	2
HIV Antiretroviral therapy (ART) status [units: participant]
On ART	61
Not on ART	6

[1]	Race/ethnicity, self-reported (NIH categories)
[2]	Hepatitis C virus (HCV) viral load testing was done using Cobas AmpliPrep/Taqman HCV Test with lower limit of quantitation of 43 IU/ml.
[3]	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.

Outcome Measures

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1. Primary:

Percentage of Participants With Complete Early Virologic Response (cEVR) [ Time Frame: Week 16 ]

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2. Primary:

Percentage of Participants With Early Virologic Response (EVR) [ Time Frame: Weeks 0, 16 ]

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3. Secondary:

Percentage of Participants With Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after treatment discontinuation ]

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4. Secondary:

Percentage of Participants With Rapid Virologic Response (RVR) [ Time Frame: Week 8 ]

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Measure Type	Secondary
Measure Title	Percentage of Participants With Rapid Virologic Response (RVR)
Measure 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
Safety Issue	No

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.
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.

Reporting Groups

	Description
NTZ/PEG/RBV	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.

Measured Values

	NTZ/PEG/RBV
Number of Participants Analyzed [units: participants]	67
Percentage of Participants With Rapid Virologic Response (RVR) [units: percentage of participants] Number (90% Confidence Interval)	10.4 (5.0 to 18.7)

No statistical analysis provided for Percentage of Participants With Rapid Virologic Response (RVR)

5. Secondary:

Number of Participants With Adverse Events of Grade 2 or Higher [ Time Frame: From study entry to up to week 76 ]

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6. Secondary:

Change in Hemoglobin Level From Study Entry [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76. ]

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7. Secondary:

Percent Change in Fasting Insulin Level From Study Entry [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]

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8. Secondary:

Percent Change in Fasting Glucose Level From Study Entry [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]

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9. Secondary:

Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]

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10. Secondary:

Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy. [ Time Frame: Weeks 0, 4 ]

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11. Secondary:

Number of Participants With HCV Genotype 1 [ Time Frame: Week 0 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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