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NCT00001035 · ClinicalTrials.gov registry record · Phase 1

The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT00001035: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00001035 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001035, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy. IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.

Interventions

  • DRUG Zidovudine
  • DRUG Didanosine
  • DRUG Zalcitabine
  • DRUG Interferon alfa-2b

Trial Details

FieldValue
Enrollment Target 10 participants
Est. Completion 1996-09
Phase Phase 1

What the finished NCT00001035 record still lists

NCT00001035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.

NCT00001035 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001035 about?

NCT00001035 is a clinical study titled "The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections". To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nuc...

What is the current status of trial NCT00001035?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. Estimated completion is 1996-09.

What interventions are being tested in trial NCT00001035?

The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG), Zalcitabine (DRUG), Interferon alfa-2b (DRUG).

Who is sponsoring clinical trial NCT00001035?

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 NCT00001035's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT00001035, the US trial registry maintained by the National Library of Medicine. NCT00001035 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.