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NCT00002387 · ClinicalTrials.gov registry record · NA

The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz

A NA study of HIV Infections, sponsored by Merck Sharp & Dohme.

Completed
Registry status
NA
Development phase
80
Enrollment target
8
Study locations

NCT00002387 is a NA study of HIV Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 80 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (82% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT00002387, a NA study of HIV Infections, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
NA
Development phase
80 participants
Enrollment target
8
Study locations

Study Summary

To estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive patients. It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that: 1. The observed proportion of patients with serum viral RNA \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks. 2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks. 3. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.

Conditions Studied

HIV Infections

Interventions

  • DRUG Efavirenz
  • DRUG Indinavir sulfate

Study Locations (8)

California

  • UCSD Treatment Ctr / Dept of Medicine & Pediatrics - San Diego
  • San Francisco Gen Hosp - San Francisco

Colorado

  • Univ of Colorado / Health Science Ctr - Denver

Hawaii

  • Hawaii AIDS Clinical Trial Unit - Honolulu

Illinois

  • Rush Med Ctr / Section of Infectious Diseases - Chicago

Massachusetts

  • Beth Israel Hosp - Boston

New York

  • Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit - Stony Brook

Rhode Island

  • Brown Univ / Miriam Hosp - Providence

Trial Details

FieldValue
Enrollment Target 80 participants
Phase NA

Sponsor

Merck Sharp & Dohme

558 total trials

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What the Registry Record Tells You About NCT00002387

The ClinicalTrials.gov registry entry for NCT00002387 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 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 (82% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Efavirenz is the first listed.

NCT00002387 reports 8 study locations spanning 7 distinct geographic areas - top geographies include California, Colorado, Hawaii.

Frequently Asked Questions

What is clinical trial NCT00002387 about?

NCT00002387 is a clinical study titled "The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz". To estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease inhibitor- and non-nucl...

What is the current status of trial NCT00002387?

This trial is currently completed. It is a NA study. The enrollment target is 80 participants.

What conditions does trial NCT00002387 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002387?

The interventions under investigation include: Efavirenz (DRUG), Indinavir sulfate (DRUG).

Who is sponsoring clinical trial NCT00002387?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002387 being conducted?

This trial has 8 study locations across California, Colorado, Hawaii, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.