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

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. Identifier: NCT01185028
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : May 15, 2013
Last Update Posted : March 21, 2018
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

  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
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]
[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   8 

  Outcome Measures

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

2.  Secondary:   Sustained Viral Response Rate   [ Time Frame: 72 weeks ]

3.  Secondary:   Tolerability   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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:  
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


Responsible Party: National Institutes of Health Clinical Center (CC) Identifier: NCT01185028     History of Changes
Other Study ID Numbers: 100183
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