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

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ClinicalTrials.gov Identifier: NCT01185028

Recruitment Status : Completed

First Posted : August 19, 2010

Results First Posted : May 15, 2013

Last Update Posted : March 21, 2018

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC)

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (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

Overall Participants Analyzed
[Units: Participants]

Age
[Units: Participants]
Count of Participants

<=18 years

0 0.0%

Between 18 and 65 years

7 87.5%

>=65 years

1 12.5%

Age ^[1]
[Units: Years]
Mean (Standard Deviation)

56.375 (7.4487834577198)

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

Sex: Female, Male
[Units: Participants]
Count of Participants

Female

2 25.0%

Male

6 75.0%

Region of Enrollment
[Units: Participants]

United States

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

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
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.

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
First Submitted:	August 18, 2010
First Posted:	August 19, 2010
Results First Submitted:	March 21, 2013
Results First Posted:	May 15, 2013
Last Update Posted:	March 21, 2018

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