A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT01185028

First received: August 18, 2010

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Results First Received: March 21, 2013

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hepatitis C Infection HIV Infection
Intervention:	Drug: Nitazoxanide With Pegylated Interferon And Ribavirin

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
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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
Nitazoxanide With Pegylated Interferon And Ribavirin	Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks

Participant Flow: Overall Study

	Nitazoxanide With Pegylated Interferon And Ribavirin
STARTED	8
COMPLETED	4
NOT COMPLETED	4

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
Nitazoxanide With Pegylated Interferon And Ribavirin	Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks

Baseline Measures

	Nitazoxanide With Pegylated Interferon And Ribavirin
Number of Participants [units: participants]	8
Age [units: participants]
<=18 years	0
Between 18 and 65 years	7
>=65 years	1
Age ^[1] [units: years] Mean (Standard Deviation)	56.375 (7.4487834577198)
Gender [units: participants]
Female	2
Male	6
Region of Enrollment [units: participants]
United States	8

[1]	Mean has been calculated to the third decimal place. Standard Deviation value has been calculated to the thirteenth decimal place

Outcome Measures

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1. Primary:

Number of Participants With Adverse Events [ Time Frame: 2 years ]

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2. Secondary:

Sustained Viral Response Rate [ Time Frame: 72 weeks ]

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Measure Type	Secondary
Measure Title	Sustained Viral Response Rate
Measure Description	Proportion of participants that are HCV negative 6 months after treatment completion
Time Frame	72 weeks
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.
No text entered.

Reporting Groups

	Description
Nitazoxanide With Pegylated Interferon And Ribavirin	Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks

Measured Values

	Nitazoxanide With Pegylated Interferon And Ribavirin
Number of Participants Analyzed [units: participants]	8
Sustained Viral Response Rate [units: participants]	8

No statistical analysis provided for Sustained Viral Response Rate

3. Secondary:

Tolerability [ Time Frame: 2 years ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

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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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. Shyam Kottilil
Organization: NIAID/NIH
phone: 301-435-0936
e-mail: skottilil@niaid.nih.gov

Publications:

Seeff LB, Buskell-Bales Z, Wright EC, Durako SJ, Alter HJ, Iber FL, Hollinger FB, Gitnick G, Knodell RG, Perrillo RP, et al. Long-term mortality after transfusion-associated non-A, non-B hepatitis. The National Heart, Lung, and Blood Institute Study Group. N Engl J Med. 1992 Dec 31;327(27):1906-11.

Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. Review.

Staples CT Jr, Rimland D, Dudas D. Hepatitis C in the HIV (human immunodeficiency virus) Atlanta V.A. (Veterans Affairs Medical Center) Cohort Study (HAVACS): the effect of coinfection on survival. Clin Infect Dis. 1999 Jul;29(1):150-4.

Responsible Party:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT01185028 History of Changes
Other Study ID Numbers:	100183 10-CC-0183
Study First Received:	August 18, 2010
Results First Received:	March 21, 2013
Last Updated:	May 16, 2013
Health Authority:	United States: Federal Government

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