CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Nitazoxanide (NTZ) +2 moredrug
Likely dose
Nitazoxanide (NTZ) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00991289
NCT00991289Phase 2Completed

The Activity of Nitazoxanide in Addition to Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Treatment-Naive Genotype 1 Subjects With HIV Coinfection

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 8, 2009·Updated Nov 4, 2021

In Brief

A Phase 2 clinical trial evaluating Nitazoxanide (NTZ), Pegylated interferon alfa-2a (PEG), and 1 other intervention for HIV Infection and Hepatitis C Infection. Completed, enrolled 68 participants across 18 sites in 2 countries.

Detailed Summary

Infection with hepatitis C virus (HCV) can cause liver scarring, or cirrhosis, and this usually occurs more rapidly among people infected with both HCV and human immunodeficiency virus (HIV). People infected with both HCV and HIV have poor response to the current HCV treatments. This phase II pilot study evaluated whether adding a new HCV medication improves response to the current standard HCV treatment with pegylated interferon and ribavirin in people with both HCV and HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2009
Enrollment StartJan 1, 2010
Primary CompletionNov 1, 2010
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.7 years ago

Interventions

Nitazoxanide (NTZ)drug

500 mg twice daily, taken orally with food

Pegylated interferon alfa-2a (PEG)drug

180 micrograms via subcutaneous injection once weekly

Ribavirin (RBV)drug

Weight-based dosing; 1,000 mg daily, taken orally, for people weighing less than 75 kg or 1,200 mg for people weighing at least 75 kg.