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NCT00992069 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers

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

Completed
Registry status
Phase 1
Development phase
37
Enrollment target
5
Study locations

NCT00992069 is a Phase 1 study of HIV and Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 37 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT00992069, a Phase 1 study of HIV and Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
37 participants
Enrollment target
5
Study locations

Study Summary

Common treatments for tuberculosis (TB) can interfere with certain antiretroviral (ARV) medications used to treat HIV. People whose immune systems are weakened by HIV infection are susceptible to TB, so it is important to find treatments for both that can be given in combination. This study will test the safety of combining a new medication for TB with an already approved HIV medication in healthy adults.

Conditions Studied

Interventions

  • DRUG Efavirenz (EFV)
  • DRUG TMC207

Study Locations (5)

California

  • Ucsf Aids Crs - San Francisco

Maryland

  • Johns Hopkins Adult AIDS CRS - Baltimore

North Carolina

  • Unc Aids Crs - Chapel Hill

Ohio

  • The Ohio State Univ. AIDS CRS - Columbus

Tennessee

  • Vanderbilt Therapeutics CRS - Nashville

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2009-12
Est. Completion 2010-12
Phase Phase 1

What the Registry Record Tells You About NCT00992069

The ClinicalTrials.gov registry entry for NCT00992069 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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

NCT00992069 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00992069 about?

NCT00992069 is a clinical study titled "Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers". Common treatments for tuberculosis (TB) can interfere with certain antiretroviral (ARV) medications used to treat HIV. People whose immune systems are weakened by HIV infection are susceptible to TB, so it is important to find treatments for both that can be given in combination. This study will tes...

What is the current status of trial NCT00992069?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2009-12. Estimated completion is 2010-12.

What conditions does trial NCT00992069 study?

This clinical trial studies the following conditions: HIV, Tuberculosis.

What interventions are being tested in trial NCT00992069?

The interventions under investigation include: Efavirenz (EFV) (DRUG), TMC207 (DRUG).

Who is sponsoring clinical trial NCT00992069?

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

Where is trial NCT00992069 being conducted?

This trial has 5 study locations across California, Maryland, North Carolina, Ohio, Tennessee. 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 Editorial

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.