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NCT02165202 · ClinicalTrials.gov registry record · Phase 2

Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis

A Phase 2 study of Human Immunodeficiency Virus (HIV), sponsored by PATH.

Completed
Registry status
Phase 2
Development phase
136
Enrollment target
4
Study locations

NCT02165202 is a Phase 2 study of Human Immunodeficiency Virus (HIV) that has completed, run by PATH. The registered enrollment target is 136 participants, below the 501-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (73% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT02165202, a Phase 2 study of Human Immunodeficiency Virus (HIV), has completed, sponsored by PATH.

COMPLETED
Registry status
Phase 2
Development phase
136 participants
Enrollment target
4
Study locations

Study Summary

This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.

Conditions Studied

Human Immunodeficiency Virus (HIV)

Interventions

  • DRUG Placebo
  • DRUG Rilpivirine

Study Locations (4)

New Jersey

  • New Jersey Medical School Clinical Research Center - Newark

New York

  • Bronx Prevention Center - The Bronx

Other

  • Emavundleni Clinical Research Site - Cape Town

Harare

  • Spilhaus Clinical Research Site - Belgravia

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2014-10
Est. Completion 2017-03-09
Phase Phase 2

Sponsor

PATH

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02165202

The ClinicalTrials.gov registry entry for NCT02165202 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 501-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (73% lower). The listed sponsor is PATH, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02165202 reports 4 study locations spanning 4 distinct geographic areas - top geographies include New Jersey, New York, Other.

Frequently Asked Questions

What is clinical trial NCT02165202 about?

NCT02165202 is a clinical study titled "Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis". This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.

What is the current status of trial NCT02165202?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2014-10. Estimated completion is 2017-03-09.

What conditions does trial NCT02165202 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV).

What interventions are being tested in trial NCT02165202?

The interventions under investigation include: Placebo (DRUG), Rilpivirine (DRUG).

Who is sponsoring clinical trial NCT02165202?

This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02165202 being conducted?

This trial has 4 study locations across New Jersey, New York, Harare. 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.