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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002381
The ClinicalTrials.gov registry entry for NCT00002381 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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