Trial Outcomes & Findings for A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures (NCT NCT01185028)

NCT ID: NCT01185028

Last Updated: 2021-10-05

Results Overview

Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: 1 year and 2 months
• Results posted on: 2021-10-05

Participant Flow

Participant milestones

Measure	Nitazoxanide With Pegylated Interferon And Ribavirin Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nitazoxanide With Pegylated Interferon And Ribavirin n=8 Participants Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	56.375 years STANDARD_DEVIATION 7.4487834577198 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year and 2 months

Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.

Outcome measures

Measure	Nitazoxanide With Pegylated Interferon And Ribavirin n=8 Participants Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Number of Participants With Adverse Events	8 participants

SECONDARY outcome

Timeframe: 1 year and 2 mos

Proportion of participants that are HCV negative 6 months after treatment completion

Outcome measures

Measure	Nitazoxanide With Pegylated Interferon And Ribavirin n=8 Participants Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Sustained Viral Response Rate	8 participants

SECONDARY outcome

Timeframe: 1 year and 2 mos

Proportion of individuals that discontinued study drug due to intolerability.

Outcome measures

Measure	Nitazoxanide With Pegylated Interferon And Ribavirin n=8 Participants Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Tolerability of Study Drug Measured as Discontinuation.	0 Participants

Adverse Events

Nitazoxanide With Pegylated Interferon And Ribavirin

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nitazoxanide With Pegylated Interferon And Ribavirin n=8 participants at risk Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Investigations Alanine aminotransferase increased	12.5% 1/8 • Number of events 9
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Number of events 14
Investigations Blood glucose increased	12.5% 1/8 • Number of events 1
Nervous system disorders Headache	12.5% 1/8 • Number of events 3
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • Number of events 9
General disorders Fatigue	12.5% 1/8 • Number of events 3
Investigations Blood creatinine increased	12.5% 1/8 • Number of events 1
Investigations Blood albumin decreased	12.5% 1/8 • Number of events 8
Renal and urinary disorders Chromaturia	12.5% 1/8 • Number of events 2
Investigations Blood potassium increased	12.5% 1/8 • Number of events 1
General disorders Chills	12.5% 1/8 • Number of events 1
Gastrointestinal disorders Flatulence	12.5% 1/8 • Number of events 2
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 3
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 3
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 2
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 3
Infections and infestations Abscess oral	12.5% 1/8 • Number of events 1
Infections and infestations Acute sinusitis	12.5% 1/8 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1
Investigations Blood calcium decreased	12.5% 1/8 • Number of events 2
Investigations Blood potassium decreased	12.5% 1/8 • Number of events 1
Skin and subcutaneous tissue disorders Dermal cyst	12.5% 1/8 • Number of events 1
Nervous system disorders Dysgeusia	12.5% 1/8 • Number of events 1
Gastrointestinal disorders Dysphagia	12.5% 1/8 • Number of events 1
Gastrointestinal disorders Gastrooesophageal reflux disease	12.5% 1/8 • Number of events 1
Hepatobiliary disorders Hyperbilirubinaemia	12.5% 1/8 • Number of events 3
Blood and lymphatic system disorders Lymphadenopathy	12.5% 1/8 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1
Investigations Neutrophil count decreased	25.0% 2/8 • Number of events 10
Investigations Platelet count decreased	12.5% 1/8 • Number of events 7
Investigations Serum albumin decreased	12.5% 1/8 • Number of events 1
Investigations White blood cell count decreased	37.5% 3/8 • Number of events 5

Additional Information

Dr. Shyam Kottilil

NIAID/NIH

Phone: 301-435-0936

Email: skottilil@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place