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NCT00002381 · ClinicalTrials.gov registry record · Phase 1

The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine

A Phase 1 study of HIV Infections, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
2
Study locations

NCT00002381: Completed Phase 1 study of HIV Infections, sponsored by Boehringer Ingelheim.

NCT00002381 is a Phase 1 study of HIV Infections that has completed, run by Boehringer Ingelheim. The registered enrollment target is 24 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002381, a Phase 1 study of HIV Infections, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
2
Study locations

Study Summary

To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the historical controls treated with nevirapine but without nelfinavir or d4T. To determine the efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor naive, and have \<= 6 months prior d4T exposure at the time of screening.

Conditions Studied

Interventions

  • DRUG Stavudine
  • DRUG Nelfinavir mesylate
  • DRUG Nevirapine

Study Locations (2)

California

  • Saint Francis Mem Hosp / HIV Care Unit - San Francisco

Rhode Island

  • Roger Williams Med Ctr - Providence

Trial Details

FieldValue
Enrollment Target 24 participants
Phase Phase 1
Boehringer Ingelheim

515 total trials

What the finished NCT00002381 record still lists

NCT00002381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower).

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Stavudine is the first listed.

NCT00002381 reports a single indexed study location in California, Rhode Island.

Frequently Asked Questions

What is clinical trial NCT00002381 about?

NCT00002381 is a clinical study titled "The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine". To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the historical controls treated with nevirap...

What is the current status of trial NCT00002381?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants.

What conditions does trial NCT00002381 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002381?

The interventions under investigation include: Stavudine (DRUG), Nelfinavir mesylate (DRUG), Nevirapine (DRUG).

Who is sponsoring clinical trial NCT00002381?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002381 being conducted?

This trial has 2 study locations across California, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00002381's enrollment target sits among peer trials

24 470th of 542 higher than 64 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections 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 NCT00002381, the US trial registry maintained by the National Library of Medicine. NCT00002381 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.