Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00991289 · ClinicalTrials.gov registry record · Phase 2

Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
68
Enrollment target

NCT00991289: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00991289 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00991289, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study 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.

Primary Outcome

Complete early virologic response (cEVR) was defined as undetectable HCV viral load (\<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).

Interventions

  • DRUG Ribavirin (RBV)
  • DRUG Nitazoxanide (NTZ)
  • DRUG Pegylated interferon alfa-2a (PEG)

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2010-01
Est. Completion 2012-01
Phase Phase 2

What the finished NCT00991289 record still lists

NCT00991289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).

The record links to 0 conditions, and to 3 interventions - of which Ribavirin (RBV) is the first listed.

NCT00991289 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00991289 about?

NCT00991289 is a clinical study titled "Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects". 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 ...

What is the current status of trial NCT00991289?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2010-01. Estimated completion is 2012-01.

What interventions are being tested in trial NCT00991289?

The interventions under investigation include: Ribavirin (RBV) (DRUG), Nitazoxanide (NTZ) (DRUG), Pegylated interferon alfa-2a (PEG) (DRUG).

Who is sponsoring clinical trial NCT00991289?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00991289's enrollment target sits among peer trials

68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02044497 · 68 participants · Phase 4

    Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients

  • NCT03779854 · 68 participants · Phase 2

    Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

  • NCT03821246 · 68 participants · Phase 2

    Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy

  • NCT04115514 · 68 participants · Phase 2

    Treatment of ARDS With Instilled T3

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00991289, the US trial registry maintained by the National Library of Medicine. NCT00991289 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.